Clinical trial • Phase III • Immunology|Rare Disease

DAZODALIBEP for Sjögren's syndrome|Sjögren's syndrome with moderate-to-severe symptom state

Phase III trial of DAZODALIBEP for Sjögren's syndrome|Sjögren's syndrome with moderate-to-severe symptom state.

Overview

Trial Therapeutic Area: Immunology|Rare Disease
Trial Disease: Sjögren's syndrome|Sjögren's syndrome with moderate-to-severe symptom state
Trial Stage: Phase III
Drug Modality: Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date: 27-02-2024
First CTIS Authorization Date: 17-06-2024

Trial design

Randomised, placebo (the placebo is formulated as sterile liquid intended for intravenous infusion following dilution in normal saline; nominal vial volume 5.0 ml; aseptically filled into 6r glass vials, stoppered and sealed).-controlled Phase III trial in France, Belgium, Germany and others.

Randomised: Yes
Comparator: Placebo (the placebo is formulated as sterile liquid intended for intravenous infusion following dilution in normal saline; nominal vial volume 5.0 mL; aseptically filled into 6R glass vials, stoppered and sealed).
Target Sample Size: 275
Trial Duration For Participant: 336

Eligibility

Recruits 275 Vulnerable population flag is selected. Inclusion requires participants to be adults (≥18 years) and 'Participants must be capable of providing their own informed consent.' Written informed consent must be obtained prior to any protocol procedures. Specific consent/ICF documents exist for pregnancy, breastfeeding, infant follow-up and optional programs; participants must be able to self-complete PROs without assistance. No paediatric participants are included..

Pregnancy Exclusion: Individuals who are pregnant or lactating or planning to become pregnant or donate eggs during the study or for 3 months after the last dose of IP (if participant withdraws from study).
Vulnerable Population: Vulnerable population flag is selected. Inclusion requires participants to be adults (≥18 years) and 'Participants must be capable of providing their own informed consent.' Written informed consent must be obtained prior to any protocol procedures. Specific consent/ICF documents exist for pregnancy, breastfeeding, infant follow-up and optional programs; participants must be able to self-complete PROs without assistance. No paediatric participants are included.

Inclusion criteria

{"criterion_text":"- 1. Adults, ≥ 18 years at time of informed consent (the minimum age for adult participants may be greater than 18 years of age in accordance with country-specific age definitions for adulthood). Participants must be capable of providing their own informed consent. 2. Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria (Section 10.1, Appendix 1). If SS diagnosis is based on positive anti-Ro autoantibody, anti-Ro positivity must be confirmed by central lab. 3. Have an ESSPRI score of ≥ 5 at screening despite current or prior symptomatic or local therapy. 4. Have an ESSDAI score of < 5 at screening. 5. Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the definition of the standard central laboratory test)."}
{"criterion_text":"- 6. Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min."}
{"criterion_text":"- 7. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the [US, EU] General Data Protection Regulation [GDPR] in the EU) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations. Participants must be able to self-complete Patient-Reported Outcomes (PROs) without assistance."}
{"criterion_text":"- 8. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from signing the informed consent form (ICF) and must agree to continue using such precautions through the end of the study or 3 months after last IP administration (if participant withdraws from study). Cessation of contraception after this point should be discussed with a responsible physician. The Investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of IP. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and must have a negative urine pregnancy test on the day of dosing prior to each dose of IP (Section 8.3.5). Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Highly effective methods of contraception (with a failure rate of < 1% per year when used consistently and correctly) include: · Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: - Oral - Intravaginal - Transdermal - Injectable · Progestogen-only hormonal contraception associated with inhibition of ovulation: - Oral - Injectable - Implantable · Intrauterine device (IUD) · Intrauterine hormone-releasing system (IUS) · Bilateral tubal occlusion · Vasectomized partner if partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of the surgical success). · Sexual abstinence Sexual abstinence is considered a highly effective method only if it is the preferred and usual lifestyle of the participant and the participant agrees to refrain from heterosexual intercourse from screening through the end of the study follow-up. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. A recommendation that the female partners (of childbearing potential) of male study participants should use a highly effective method of contraception other than a barrier method should be made. - Females of childbearing potential are defined as those who are not surgically sterile (surgical sterilization includes bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or those who are not postmenopausal (defined as 12 - consecutive months with no menses without an alternative medical cause). - Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the woman of childbearing potential study participant and that the vasectomized partner has received medical assessment of the surgical success)."}
{"criterion_text":"- 10. Meets all of the following tuberculosis (TB) criteria: a. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment. b. No signs or symptoms suggestive of active TB from medical history or physical examination. c. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor). d. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion 11(a). Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded. If IGRA result by central laboratory is incongruent with recent local testing within 4 weeks prior to or during screening, a repeat assessment will be permitted. e. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS)."}

Exclusion criteria

{"criterion_text":"- 1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening."}
{"criterion_text":"- 2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis."}
{"criterion_text":"- 3. Active malignancy or history of malignancy within the last 5 years, except as follows: a. In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR b. Cutaneous basal cell carcinoma following presumed curative therapy."}
{"criterion_text":"- 4. Individuals who are pregnant or lactating or planning to become pregnant or donate eggs during the study or for 3 months after the last dose of IP (if participant withdraws from study)."}
{"criterion_text":"- 5. Individuals who have a positive test for, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. A positive test for hepatitis B at screening is defined as: (1) positive for hepatitis B surface antigen (HBsAg); OR (2) positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) AND hepatitis B virus (HBV) DNA detected above the lower limit of quantification (LLOQ) by reflex testing by the central laboratory at screening. Individuals with a positive test for or a history of treatment for hepatitis C are excluded unless they have a documented sustained viral response to antiviral drugs approved for the treatment of hepatitis C, defined as an undetectable viral level of hepatitis C RNA at least 24 weeks following completion of therapy. Individuals with advanced fibrosis or cirrhosis due to hepatitis C should not be enrolled."}
{"criterion_text":"- 6. Individuals with a positive test for SARS-CoV-2 on the day of randomization. Only those with symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to (COVID-19) within 10 days prior to randomization, should be tested. Individuals with COVID-19 or COVID-19 exposure can delay randomization for 10 days and randomize once recovered; otherwise, they will need to rescreen."}
{"criterion_text":"- 7a. Any opportunistic infections in the last 12 months (Section 10.3, Appendix 3), with the exception of a single episode of herpes zoster, non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity."}
{"criterion_text":"- 7b. Active infections requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening."}
{"criterion_text":"- 8. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy."}
{"criterion_text":"- 9. Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results."}
{"criterion_text":"- 10. Individuals who, in the opinion of the Investigator, are unable or unwilling to comply with protocol requirements (eg, active drug or alcohol abuse or for other reasons), including the completion of the DASPRI and PRO."}
{"criterion_text":"- 11. Individuals who have received live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study. Non-live vaccines are permitted during study (see Inclusion Criterion 10 for COVID-19 vaccination); however, for participants planning to receive a vaccine within a month after Dose 1, completing vaccination prior to starting dosing should be considered by the Investigator."}
{"criterion_text":"- 12. Last administration of experimental or investigational biologic or oral agents (other than those listed in Exclusion Criterion 15) < 6 months prior to screening."}
{"criterion_text":"- 13. Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) < 3 months prior to screening."}
{"criterion_text":"- 14. Individuals treated with systemic corticosteroids for indications other than SS, RA, and SLE for more than a total of 2 weeks within 6 months prior to screening."}
{"criterion_text":"- 15a. Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) if they have been initiated or if the dose has changed within 8 weeks prior to screening or during the screening period."}
{"criterion_text":"- 15b. Oral, intramuscular, (IM), IV, or intra-articular (IA) corticosteroids within 4 weeks prior to screening. Pro re nata (PRN) use of oral corticosteroids is not allowed during the screening window and through randomization. Inhaled, intranasal, or topical corticosteroids are allowed provided doses are expected to be stable during the study."}
{"criterion_text":"- 15c. Methotrexate, azathioprine, leflunomide, mycophenolate mofetil (MMF), other disease-modifying anti-rheumatic drug (DMARD), immunosuppressant, immunosuppressive biologics, or antiproliferative agents if last dose was taken within: 4 weeks prior to screening; OR drug-specific 5 half-lives elimination period (if longer than 4 weeks)."}
{"criterion_text":"- 15d. Any medication that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of participant safety or study results."}
{"criterion_text":"- 15e. Any increase or initiation of a new dose of regularly scheduled nonsteroidal anti-inflammatory drugs within 2 weeks prior to screening through randomization (Day 1)."}
{"criterion_text":"- 15f. Any increase or initiation of new doses of cevimeline, pilocarpine, or cyclosporine eye drops (Restasis®) or lifitegrast (Xiidra®) or any other topical (ophthalmic) anti-inflammatory/ immunomodulatory eyedrops within 2 weeks prior to screening through randomization (Day 1)."}
{"criterion_text":"- 15g. Use of herbal or homeopathic remedies for underlying rheumatological conditions, specifically sinomenine, tripterygium glycosides, or total glucosides of peony, within 4 weeks prior to screening."}
{"criterion_text":"- 16. Individuals who have received previous treatment with anti-CD40L compounds at any time before screening."}
{"criterion_text":"- 17. Individuals with blood tests, at screening, of any of the following: Aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN); Alanine aminotransferase (ALT) > 2 × ULN; Total bilirubin (TBL) > 2 × ULN, unless Gilbert’s syndrome is documented in the medical history; Hemoglobin < 90 g/L; Neutrophils < 1.0 × 109/L; Lymphocytes < 0.5 × 109/L; Platelets < 100 × 109/L; International normalized ratio (INR) > 1.3."}

Endpoints

Primary endpoints

{"endpoint_text":"- 1. Change from baseline in Diary for Assessing Sjögren’s Patient Reported Index (DASPRI) score at Week 48 (Plan A)","definition_or_measurement_approach":"Change from baseline at Week 48 measured using the DASPRI patient diary (Plan A)."}
{"endpoint_text":"- 2. Change from baseline in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score at Week 48 (Plan B)","definition_or_measurement_approach":"Change from baseline at Week 48 measured using the ESSPRI patient-reported index (Plan B)."}

Secondary endpoints

{"endpoint_text":"- 1.\tProportion of participants achieving a meaningful improvement in DASPRIb (Plan A) or ESSPRI[1.5] (Plan B) response, defined as a decrease of at least 1.5 points from baseline in the ESSPRI score, without premature discontinuation from treatment and without receiving rescue or potentially confounding therapy.","definition_or_measurement_approach":"Responder analysis: proportion meeting defined decrease (≥1.5 points in ESSPRI) at specified timepoint(s), excluding those with premature discontinuation or rescue therapy."}
{"endpoint_text":"- 2. Change from baseline in DASPRI Dryness (Plan A) or ESSPRI Dryness (Plan B) at Week 48","definition_or_measurement_approach":"Change from baseline in the dryness domain of DASPRI (Plan A) or ESSPRI (Plan B) at Week 48."}
{"endpoint_text":"- 3. Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a) at Week 48 (Plan A and Plan B)","definition_or_measurement_approach":"Change from baseline in PROMIS-Fatigue SF-10a score at Week 48."}
{"endpoint_text":"- 4. Change from baseline in DASPRI Pain (Plan A) or ESSPRI Pain (Plan B) at Week 48","definition_or_measurement_approach":"Change from baseline in the pain domain (DASPRI or ESSPRI) at Week 48."}
{"endpoint_text":"- 5. Change from baseline in at Week 48 (Plan B only)","definition_or_measurement_approach":"Text as provided in protocol; specific instrument/measure not fully specified in public summary (Plan B only)."}
{"endpoint_text":"- 6. Change from baseline in DASPRI total score (Plan A) or ESSPRI total score (Plan B) at Week 12 and Week 24","definition_or_measurement_approach":"Change from baseline in total DASPRI (Plan A) or ESSPRI (Plan B) at Weeks 12 and 24."}
{"endpoint_text":"- 7. Change from baseline in DASPRI Fatigue (Plan A) or ESSPRI Fatigue (Plan B) at Week 48","definition_or_measurement_approach":"Change from baseline in the fatigue domain (DASPRI/ESSPRI) at Week 48."}
{"endpoint_text":"- 8. Change from baseline in total stimulated salivary flow at Week 48 (Plan A and Plan B).","definition_or_measurement_approach":"Change from baseline in whole stimulated salivary flow (mL/min) at Week 48."}
{"endpoint_text":"- 9. Pharmacokinetic concentration of dazodalibep in plasma including maximum plasma concentration (Cmax) and minimum plasma concentration (Cmin).","definition_or_measurement_approach":"Plasma PK sampling to determine Cmax and Cmin for dazodalibep."}
{"endpoint_text":"- 10. Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events of special interest (AESIs).","definition_or_measurement_approach":"Safety monitoring: incidence and characterization of TEAEs, TESAEs and AESIs during treatment and follow-up."}

Recruitment

Registry Or Advocacy Recruitment: True, Sjogren’s Foundation
Digital Remote Recruitment: True, use of digital/remote methods is planned (digital/payed search ads, program website, digital prescreener forms, social media ads and digital recruitment campaign materials localized per country).
Planned Sample Size: 275
Recruitment Window Months: 47
Consent Approach: Written informed consent is required from each participant prior to any protocol procedures; participants must be ≥18 and 'capable of providing their own informed consent.' Multiple ICF documents exist (main ICF and specific forms for pregnancy, breastfeeding, infant follow-up, optional programs, transport/concierge) and are provided in local languages (examples in the public documents include French, German, Portuguese, Dutch, English, Polish, Spanish, Greek, Hungarian, Italian, Croatian, Slovenian, Danish).

Methods

Digital advertising (paid search, digital ads) and program website prescreeners (country-specific digital recruitment materials referenced in recruitment documents).
Printed materials and direct mail: brochures, brochure inserts, flyers and GP/physician letters developed for local languages/countries.
Referral pathways and prescreener: HCP referral letters and referral confirmation procedures described in recruitment materials.
Patient outreach via patient advocacy group materials (Sjogren’s Foundation involvement in patient materials).
Concierge/transportation assistance and travel reimbursement arrangements (travel vendor and reimbursement services listed).

Geography

Total Number Of Sites: 80
Total Number Of Participants: 194

France

Earliest CTIS Part Ii Submission Date: 14-05-2024
Latest Decision Or Authorization Date: 19-03-2026
Processing Time Days: 674
Number Of Sites: 5
Number Of Participants: 9

Sites

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Service de Médicine Interne
Principal Investigator Name: Vincent JACHIET
Principal Investigator Email: vincent.jachiet@aphp.fr
Contact Person Name: Vincent JACHIET
Contact Person Email: vincent.jachiet@aphp.fr

Site Name: Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name: Service de Médicine interne et immunologie clinique
Principal Investigator Name: Benjamin DERVIEUX
Principal Investigator Email: benjamin.dervieux@ghrmsa.fr
Contact Person Name: Benjamin DERVIEUX
Contact Person Email: benjamin.dervieux@ghrmsa.fr

Site Name: Centre Hospitalier Regional Et Universitaire De Brest
Department Name: Service de Rhumatologie
Principal Investigator Name: Valérie DEVAUCHELLE_PENSEC
Principal Investigator Email: valerie.devauchelle-pensec@chu-brest.fr
Contact Person Name: Valérie DEVAUCHELLE_PENSEC
Contact Person Email: valerie.devauchelle-pensec@chu-brest.fr

Site Name: Les Hopitaux Universitaires De Strasbourg
Department Name: Service de Rhumatologie
Principal Investigator Name: Jacques Eric GOTTENBERG
Principal Investigator Email: jacques-eric.gottenberg@chu-strasbourg.fr
Contact Person Name: Jacques Eric GOTTENBERG
Contact Person Email: jacques-eric.gottenberg@chu-strasbourg.fr

Site Name: Centre Hospitalier Universitaire De Bordeaux
Department Name: Service de Médicine interne et immunologie clinique
Principal Investigator Name: Noémie GENSOUS
Principal Investigator Email: noemie.gensous@chu-bordeaux.fr
Contact Person Name: Noémie GENSOUS
Contact Person Email: noemie.gensous@chu-bordeaux.fr

Belgium

Earliest CTIS Part Ii Submission Date: 16-05-2024
Latest Decision Or Authorization Date: 19-03-2026
Processing Time Days: 672
Number Of Sites: 1
Number Of Participants: 3

Sites

Site Name: Universitair Ziekenhuis Gent
Department Name: Rheumatology
Principal Investigator Name: Isabelle Peene
Principal Investigator Email: Isabelle.Peene@uzgent.be
Contact Person Name: Isabelle Peene
Contact Person Email: Isabelle.Peene@uzgent.be

Germany

Earliest CTIS Part Ii Submission Date: 27-05-2024
Latest Decision Or Authorization Date: 23-03-2026
Processing Time Days: 665
Number Of Sites: 7
Number Of Participants: 13

Sites

Site Name: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name: HRF II - Hamburger Rheuma Forschungszentrum II
Principal Investigator Name: Andrea Everding
Principal Investigator Email: everding@hotmail.de
Contact Person Name: Andrea Everding
Contact Person Email: everding@hotmail.de

Site Name: Rheumazentrum Greifswald
Department Name: Rheumazentrum Greifswald
Principal Investigator Name: Michael Fiene
Principal Investigator Email: michael.fiene@rheumazentrum-greifswald.info
Contact Person Name: Michael Fiene
Contact Person Email: michael.fiene@rheumazentrum-greifswald.info

Site Name: University Medical Center Hamburg-Eppendorf
Department Name: III. Medizinische Klinik und Poliklinik Nephrologie, Rheumatologie und Endokrinologie
Principal Investigator Name: Ina Kötter
Principal Investigator Email: ina.koetter@klinikumbb.de
Contact Person Name: Ina Kötter
Contact Person Email: ina.koetter@klinikumbb.de

Site Name: Universitaetsklinikum Heidelberg AöR
Department Name: Klinik für Hämatologie, Onkologie, Rheumatologie
Principal Investigator Name: Norbert Blank
Principal Investigator Email: norbert.blank@med.uni-heidelberg.de
Contact Person Name: Norbert Blank
Contact Person Email: norbert.blank@med.uni-heidelberg.de

Site Name: Medical Center - University Of Freiburg
Department Name: Klinik für Rheumatologie und Klinische Immunologie
Principal Investigator Name: Stephanie Finzel
Principal Investigator Email: stephanie.finzel@uniklinik-freiburg.de
Contact Person Name: Stephanie Finzel
Contact Person Email: stephanie.finzel@uniklinik-freiburg.de

Site Name: BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH
Department Name: MVZ Rheumazentrum Prof. Dr. med. Gunther Neeck
Principal Investigator Name: Gunther Neeck
Principal Investigator Email: gunther.neeck@biomedro.de
Contact Person Name: Gunther Neeck
Contact Person Email: gunther.neeck@biomedro.de

Site Name: Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus Sachsen GmbH
Department Name: Hautklinik
Principal Investigator Name: Martin Kaatz
Principal Investigator Email: Kaatz.Martin@drk-khs.de
Contact Person Name: Martin Kaatz
Contact Person Email: Kaatz.Martin@drk-khs.de

Portugal

Earliest CTIS Part Ii Submission Date: 16-05-2024
Latest Decision Or Authorization Date: 23-03-2026
Processing Time Days: 676
Number Of Sites: 4
Number Of Participants: 9

Sites

Site Name: Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Department Name: Reumatology
Principal Investigator Name: Taciana Videira
Principal Investigator Email: taciana.videira@chvng.min-saude.pt
Contact Person Name: Taciana Videira
Contact Person Email: taciana.videira@chvng.min-saude.pt

Site Name: Centro Hospitalar De Lisboa Ocidental E.P.E.
Department Name: Rheumatology Service
Principal Investigator Name: Fernando Pimentel Santos
Principal Investigator Email: pimentel.santos@nms.unl.pt
Contact Person Name: Fernando Pimentel Santos
Contact Person Email: pimentel.santos@nms.unl.pt

Site Name: Unidade Local De Saude Do Alto Minho E.P.E.
Department Name: Reumatology Service
Principal Investigator Name: Daniela Peixoto
Principal Investigator Email: danielapeixoto81@hotmail.com
Contact Person Name: Daniela Peixoto
Contact Person Email: danielapeixoto81@hotmail.com

Site Name: Unidade Local De Saude De Santa Maria E.P.E.
Department Name: Reumatology
Principal Investigator Name: Nikita Khmelinskii
Principal Investigator Email: nkhmelinskii@gmail.com
Contact Person Name: Nikita Khmelinskii
Contact Person Email: nkhmelinskii@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date: 20-05-2024
Latest Decision Or Authorization Date: 04-08-2025
Processing Time Days: 441
Number Of Sites: 3
Number Of Participants: 9

Sites

Site Name: Aarhus Universitetshospital
Department Name: Department of Rheumatology
Principal Investigator Name: Ellen-Margrethe Hauge
Principal Investigator Email: ellhau@rm.dk
Contact Person Name: Ellen-Margrethe Hauge
Contact Person Email: ellhau@rm.dk

Site Name: Lillebaelt Hospital
Department Name: Medicinsk afdeling
Principal Investigator Name: Tine Lottenburger
Principal Investigator Email: tine.lottenburger@rsyd.dk
Contact Person Name: Tine Lottenburger
Contact Person Email: tine.lottenburger@rsyd.dk

Site Name: Odense University Hospital
Department Name: Department of Rheumatology
Principal Investigator Name: Torkell Juulsgaard Ellingsen
Principal Investigator Email: torkell.ellingsen@rsyd.dk
Contact Person Name: Torkell Juulsgaard Ellingsen
Contact Person Email: torkell.ellingsen@rsyd.dk

Slovenia

Earliest CTIS Part Ii Submission Date: 21-05-2024
Latest Decision Or Authorization Date: 19-03-2026
Processing Time Days: 667
Number Of Sites: 2
Number Of Participants: 5

Sites

Site Name: University Medical Center Ljubljana
Department Name: Clinical Department of Rheumatology
Principal Investigator Name: Ziga Rotar
Principal Investigator Email: ziga.rotar@kclj.si
Contact Person Name: Ziga Rotar
Contact Person Email: ziga.rotar@kclj.si

Site Name: UNIVERZITETNI KLINICNI CENTER MARIBOR
Department Name: Department of Rheumatology
Principal Investigator Name: Iztok Holc
Principal Investigator Email: Iztok.HOLC@ukc-mb.si
Contact Person Name: Iztok Holc
Contact Person Email: Iztok.HOLC@ukc-mb.si

Croatia

Earliest CTIS Part Ii Submission Date: 10-05-2024
Latest Decision Or Authorization Date: 24-03-2026
Processing Time Days: 683
Number Of Sites: 5
Number Of Participants: 13

Sites

Site Name: KBC Split
Department Name: Department of Rheumatology, Allergology and Clinical Immunology
Principal Investigator Name: Dijana Perkovic
Principal Investigator Email: dperkov@kbsplit.hr
Contact Person Name: Dijana Perkovic
Contact Person Email: dperkov@kbsplit.hr

Site Name: Klinicki Bolnicki Centar Osijek
Department Name: Department of Rheumatology, Allergology and Clinical Immunology
Principal Investigator Name: Jasminka Milas Ahic
Principal Investigator Email: milas-ahic.jasminka@kbco.hr
Contact Person Name: Jasminka Milas Ahic
Contact Person Email: milas-ahic.jasminka@kbco.hr

Site Name: University Hospital Sveti Duh
Department Name: Department Of Physical Medicine and Rehabilitation
Principal Investigator Name: Ksenija Mastrovic Radoncic
Principal Investigator Email: kmastrovic@kbsd.hr
Contact Person Name: Ksenija Mastrovic Radoncic
Contact Person Email: kmastrovic@kbsd.hr

Site Name: KBC Zagreb
Department Name: Clinic For Rheumatic Diseases and Rehabilitation
Principal Investigator Name: Porin Peric
Principal Investigator Email: porin.peric@gmail.com
Contact Person Name: Porin Peric
Contact Person Email: porin.peric@gmail.com

Site Name: Poliklinika BONIFARM
Department Name: Clinical and Clinical Research Department
Principal Investigator Name: Marinko Bilusic
Principal Investigator Email: mbilusic@bonifarm.hr
Contact Person Name: Marinko Bilusic
Contact Person Email: mbilusic@bonifarm.hr

Spain

Earliest CTIS Part Ii Submission Date: 25-04-2024
Latest Decision Or Authorization Date: 24-03-2026
Processing Time Days: 698
Number Of Sites: 13
Number Of Participants: 24

Sites

Site Name: Hospital Universitario Basurto
Department Name: Rheumatology
Principal Investigator Name: Esther Ruiz Lucea
Principal Investigator Email: MARIAESTHER.RUIZLUCEA@osakidetza.eus
Contact Person Name: Esther Ruiz Lucea
Contact Person Email: MARIAESTHER.RUIZLUCEA@osakidetza.eus

Site Name: Hospital Universitario Dr Peset Aleixandre
Department Name: Rheumatology
Principal Investigator Name: Ignacio Vázquez Gómez
Principal Investigator Email: nachovg23@gmail.com
Contact Person Name: Ignacio Vázquez Gómez
Contact Person Email: nachovg23@gmail.com

Site Name: Hospital Universitario 12 De Octubre
Department Name: Rheumatology
Principal Investigator Name: Sheila Melchor Díaz
Principal Investigator Email: sheila.melchor@salud.madrid.org
Contact Person Name: Sheila Melchor Díaz
Contact Person Email: sheila.melchor@salud.madrid.org

Site Name: Hospital Universitario Hospiten Rambla
Department Name: Rheumatology
Principal Investigator Name: Jerónimo Balsalobre Aznar
Principal Investigator Email: balsalobre2@yahoo.es
Contact Person Name: Jerónimo Balsalobre Aznar
Contact Person Email: balsalobre2@yahoo.es

Site Name: Hospital General Universitario Reina Sofia
Department Name: Rheumatology
Principal Investigator Name: Rafaela Ortega Castro
Principal Investigator Email: orcam84@hotmail.com
Contact Person Name: Rafaela Ortega Castro
Contact Person Email: orcam84@hotmail.com

Site Name: Fundacio Hospital De L'Esperit Sant
Department Name: Internal Medicine
Principal Investigator Name: Gloria De La Red Bellvis
Principal Investigator Email: gred@fhes.cat
Contact Person Name: Gloria De La Red Bellvis
Contact Person Email: gred@fhes.cat

Site Name: Hospital Universitario Araba
Department Name: Rheumatology
Principal Investigator Name: Juan María Blanco Madrigal
Principal Investigator Email: juanmaria.blancomadrigal@osakidetza.eus
Contact Person Name: Juan María Blanco Madrigal
Contact Person Email: juanmaria.blancomadrigal@osakidetza.eus

Site Name: Hospital Universitario La Paz
Department Name: Rheumatology
Principal Investigator Name: Maria Gema Bonilla Hernán
Principal Investigator Email: gemabonilla@ser.es
Contact Person Name: Maria Gema Bonilla Hernán
Contact Person Email: gemabonilla@ser.es

Site Name: University Hospital Of Canary Islands
Department Name: Rheumatology
Principal Investigator Name: Federico Diaz-Gonzalez
Principal Investigator Email: federico.diaz.gonzalez@gmail.com
Contact Person Name: Federico Diaz-Gonzalez
Contact Person Email: federico.diaz.gonzalez@gmail.com

Site Name: Hospital Quironsalud Infanta Luisa
Department Name: Rheumatology
Principal Investigator Name: Lola Fernandez de la Fuente Burson
Principal Investigator Email: lolaffb@gmail.com
Contact Person Name: Lola Fernandez de la Fuente Burson
Contact Person Email: lolaffb@gmail.com

Site Name: Complexo Hospitalario Universitario A Coruna
Department Name: Rheumatology
Principal Investigator Name: Francisco Javier Blanco Garcia
Principal Investigator Email: fblagar@sergas.es
Contact Person Name: Francisco Javier Blanco Garcia
Contact Person Email: fblagar@sergas.es

Site Name: Hospital General Universitario Gregorio Maranon
Department Name: Rheumatology
Principal Investigator Name: Belen Serrano
Principal Investigator Email: bserranob@salud.madrid.org
Contact Person Name: Belen Serrano
Contact Person Email: bserranob@salud.madrid.org

Site Name: Hospital Universitario Virgen De Valme
Department Name: Rheumatology
Principal Investigator Name: Rosalia Martinez Perez
Principal Investigator Email: rosalia.martinez.perez@gmail.com
Contact Person Name: Rosalia Martinez Perez
Contact Person Email: rosalia.martinez.perez@gmail.com

Greece

Earliest CTIS Part Ii Submission Date: 12-03-2024
Latest Decision Or Authorization Date: 24-03-2026
Processing Time Days: 742
Number Of Sites: 3
Number Of Participants: 8

Sites

Site Name: Euromedica Kyanous Stavros
Department Name: Rheumatology Department
Principal Investigator Name: Lucas Settas
Principal Investigator Email: loukassettas@gmail.com
Contact Person Name: Lucas Settas
Contact Person Email: loukassettas@gmail.com

Site Name: Laiko General Hospital Of Athens
Department Name: Pathophysiology Department
Principal Investigator Name: Andreas Goules
Principal Investigator Email: agoules@med.uoa.gr
Contact Person Name: Andreas Goules
Contact Person Email: agoules@med.uoa.gr

Site Name: General University Hospital Of Larissa
Department Name: Dept of Rheumatology & Clinical Immunology
Principal Investigator Name: Christina Katsiari
Principal Investigator Email: cgk2005@gmail.com
Contact Person Name: Christina Katsiari
Contact Person Email: cgk2005@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date: 02-05-2024
Latest Decision Or Authorization Date: 23-03-2026
Processing Time Days: 690
Number Of Sites: 3
Number Of Participants: 8

Sites

Site Name: Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name: Hematológiai és Infektológiai
Principal Investigator Name: KÁDÁR János
Principal Investigator Email: drkadarj@t-online.hu
Contact Person Name: KÁDÁR János
Contact Person Email: drkadarj@t-online.hu

Site Name: Vasarhelyi Sarkanyfu Kft.
Principal Investigator Name: BALÁZS Éva
Principal Investigator Email: jimbies@gmail.hu
Contact Person Name: BALÁZS Éva
Contact Person Email: jimbies@gmail.hu

Site Name: Bekes Varmegyei Koezponti Korhaz
Department Name: Infektologiai (Hepatologiai, Immunologiai) Osztaly
Principal Investigator Name: MARTYIN Tibor
Principal Investigator Email: martyintibor@freemail.hu
Contact Person Name: MARTYIN Tibor
Contact Person Email: martyintibor@freemail.hu

Poland

Earliest CTIS Part Ii Submission Date: 20-05-2024
Latest Decision Or Authorization Date: 23-03-2026
Processing Time Days: 672
Number Of Sites: 21
Number Of Participants: 80

Sites

Site Name: Futuremeds Warszawa Centrum
Principal Investigator Name: Izabella Gładysz
Principal Investigator Email: izabella.gladysz@futuremeds.com
Contact Person Name: Izabella Gładysz
Contact Person Email: izabella.gladysz@futuremeds.com

Site Name: CENTRUM MEDYCZNE PRATIA KATOWICE
Principal Investigator Name: Tomasz Dziewit
Principal Investigator Email: tdziewit@poczta.onet.pl
Contact Person Name: Tomasz Dziewit
Contact Person Email: tdziewit@poczta.onet.pl

Site Name: Mtz Clinical Research Powered By Pratia
Principal Investigator Name: Robert Rupiński
Principal Investigator Email: rupinski@mp.pl
Contact Person Name: Robert Rupiński
Contact Person Email: rupinski@mp.pl

Site Name: Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Principal Investigator Name: Magdalena Celińska-Löwenhoff
Principal Investigator Email: magdalena.lowenhoff@gmail.com
Contact Person Name: Magdalena Celińska-Löwenhoff
Contact Person Email: magdalena.lowenhoff@gmail.com

Site Name: Pracownia Badań Klinicznych Salus
Principal Investigator Name: Katarzyna Rachwał-Siek
Principal Investigator Email: katarzyna.rachwal-siek@pbks.com.pl
Contact Person Name: Katarzyna Rachwał-Siek
Contact Person Email: katarzyna.rachwal-siek@pbks.com.pl

Site Name: Malopolskie Centrum Kliniczne
Principal Investigator Name: Ewa Zimmer-Satora
Principal Investigator Email: ezimersatora@mck-krakow.pljolas
Contact Person Name: Ewa Zimmer-Satora
Contact Person Email: ezimersatora@mck-krakow.pljolas

Site Name: ETG Lublin
Principal Investigator Name: Barbara Nieradko-Iwanicka
Principal Investigator Email: bb.nieradkoiwanicka@etg-network.com
Contact Person Name: Barbara Nieradko-Iwanicka
Contact Person Email: bb.nieradkoiwanicka@etg-network.com

Site Name: CENTRUM MEDYCZNE REUMA PARK
Principal Investigator Name: Paula Śliwińska-Stańczyk
Principal Investigator Email: stanczyki@post.pl
Contact Person Name: Paula Śliwińska-Stańczyk
Contact Person Email: stanczyki@post.pl

Site Name: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name: Oddział Kliniczny Reumatologii
Principal Investigator Name: Piotr Wiland
Principal Investigator Email: pwiland1@gmail.com
Contact Person Name: Piotr Wiland
Contact Person Email: pwiland1@gmail.com

Site Name: Reumed Sp. z o.o.
Principal Investigator Name: Mariusz Piotrowski
Principal Investigator Email: mariusz_piotrowski@yahoo.com
Contact Person Name: Mariusz Piotrowski
Contact Person Email: mariusz_piotrowski@yahoo.com

Site Name: Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name: Centrum Wsparcia Badań Klinicznych
Principal Investigator Name: Brygida Kwiatkowska
Principal Investigator Email: brygida.kwiatkowska@spartanska.pl
Contact Person Name: Brygida Kwiatkowska
Contact Person Email: brygida.kwiatkowska@spartanska.pl

Site Name: FutureMeds Wrocław
Principal Investigator Name: Ewa Krecipro-Nizińska
Principal Investigator Email: ewa.krecipro-nizinska@futuremeds.com
Contact Person Name: Ewa Krecipro-Nizińska
Contact Person Email: ewa.krecipro-nizinska@futuremeds.com

Site Name: MICS Centrum Medyczne Warszawa
Principal Investigator Name: Małgorzata Socik-Pojawa
Principal Investigator Email: malgorzatasocikpojawa@medycynakliniczna.pl
Contact Person Name: Małgorzata Socik-Pojawa
Contact Person Email: malgorzatasocikpojawa@medycynakliniczna.pl

Site Name: Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name: Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
Principal Investigator Name: Rafał Wojciechowski
Principal Investigator Email: r.wojciechowski@wp.eu
Contact Person Name: Rafał Wojciechowski
Contact Person Email: r.wojciechowski@wp.eu

Site Name: Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name: Centrum Wsparcia Badań Klinicznych
Principal Investigator Name: Joanna Kur-Zalewska
Principal Investigator Email: jkur-zalewska@wim.mil.pl
Contact Person Name: Joanna Kur-Zalewska
Contact Person Email: jkur-zalewska@wim.mil.pl

Site Name: Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
Principal Investigator Name: Agnieszka Bielewicz-Zielińska
Principal Investigator Email: a.bielewicz-zielinska@klinikabadawcza.pl
Contact Person Name: Agnieszka Bielewicz-Zielińska
Contact Person Email: a.bielewicz-zielinska@klinikabadawcza.pl

Site Name: Centrum Medyczne K2J2
Principal Investigator Name: Katarzyna Kamińska-Stachniak
Principal Investigator Email: k.kaminska-stachniak@k2j2.pl
Contact Person Name: Katarzyna Kamińska-Stachniak
Contact Person Email: k.kaminska-stachniak@k2j2.pl

Site Name: Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name: Agata Wytyk-Nowak
Principal Investigator Email: wytyk@twojaprzychodnia.com
Contact Person Name: Agata Wytyk-Nowak
Contact Person Email: wytyk@twojaprzychodnia.com

Site Name: Futuremeds Łódź
Principal Investigator Name: Katarzyna Bartnicka-Masłowska
Principal Investigator Email: katarzyna.bartnicka@futuremeds.com
Contact Person Name: Katarzyna Bartnicka-Masłowska
Contact Person Email: katarzyna.bartnicka@futuremeds.com

Site Name: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name: Klinika Reumatologii i Chorób Wewnętrznych
Principal Investigator Name: Piotr Wiland
Principal Investigator Email: pwiland1@gmail.com
Contact Person Name: Piotr Wiland
Contact Person Email: pwiland1@gmail.com

Site Name: Centrum Medyczne Oporow
Principal Investigator Name: Maria Misterska-Skóra
Principal Investigator Email: maria.misterska-skora@cmoporow.com
Contact Person Name: Maria Misterska-Skóra
Contact Person Email: maria.misterska-skora@cmoporow.com

Italy

Earliest CTIS Part Ii Submission Date: 15-05-2024
Latest Decision Or Authorization Date: 24-03-2026
Processing Time Days: 678
Number Of Sites: 13
Number Of Participants: 13

Sites

Site Name: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name: Malattie Autoimmuni Sistemiche
Principal Investigator Name: Lorenzo Beretta
Principal Investigator Email: lorenzo.beretta@policlinico.mi.it
Contact Person Name: Lorenzo Beretta
Contact Person Email: lorenzo.beretta@policlinico.mi.it

Site Name: Azienda USL IRCCS Di Reggio Emilia
Principal Investigator Name: Lucia Dardani
Principal Investigator Email: lucia.dardani@ausl.re.it
Contact Person Name: Lucia Dardani
Contact Person Email: lucia.dardani@ausl.re.it

Site Name: Centro Ricerche Cliniche Di Verona S.r.l.
Department Name: Reumatologia
Principal Investigator Name: Luca Idolazzi
Principal Investigator Email: luca.idolazzi@univr.it
Contact Person Name: Luca Idolazzi
Contact Person Email: luca.idolazzi@univr.it

Site Name: Careggi University Hospital
Department Name: Medicina Interna Interdisciplinare
Principal Investigator Name: Elena Silvestri
Principal Investigator Email: elena.silvestri@unifi.it
Contact Person Name: Elena Silvestri
Contact Person Email: elena.silvestri@unifi.it

Site Name: Azienda Ospedaliero Universitaria Pisana
Department Name: Reumatologia
Principal Investigator Name: Chiara Baldini
Principal Investigator Email: chiara.baldini74@gmail.com
Contact Person Name: Chiara Baldini
Contact Person Email: chiara.baldini74@gmail.com

Site Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name: Reumatologia
Principal Investigator Name: Maria Antonietta D’Agostino
Principal Investigator Email: mariaantonietta.dagostino@policlinicogemelli.it
Contact Person Name: Maria Antonietta D’Agostino
Contact Person Email: mariaantonietta.dagostino@policlinicogemelli.it

Site Name: Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name: Reumatologia
Principal Investigator Name: Pier Paolo Sainaghi
Principal Investigator Email: pierpaolo.sainaghi@med.uniupo.it
Contact Person Name: Pier Paolo Sainaghi
Contact Person Email: pierpaolo.sainaghi@med.uniupo.it

Site Name: Fondazione Policlinico Universitario Campus Bio-medico
Department Name: Immunoreumatologia
Principal Investigator Name: Roberto Giacomelli
Principal Investigator Email: r.giacomelli@unicampus.it
Contact Person Name: Roberto Giacomelli
Contact Person Email: r.giacomelli@unicampus.it

Site Name: Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name: UO Reumatologia
Principal Investigator Name: Rosario Foti
Principal Investigator Email: rosfoti5@gmail.com
Contact Person Name: Rosario Foti
Contact Person Email: rosfoti5@gmail.com

Site Name: Azienda Sanitaria Universitaria Friuli Centrale
Department Name: Reumatologia
Principal Investigator Name: Luca Quartuccio
Principal Investigator Email: luca.quartuccio@asufc.sanita.fvg.it
Contact Person Name: Luca Quartuccio
Contact Person Email: luca.quartuccio@asufc.sanita.fvg.it

Site Name: Centro Ricerche Cliniche Di Verona S.r.l. (additional listed site entry)
Department Name: Reumatologia
Principal Investigator Name: Luca Idolazzi
Principal Investigator Email: luca.idolazzi@univr.it
Contact Person Name: Luca Idolazzi
Contact Person Email: luca.idolazzi@univr.it

Site Name: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (additional listed site entry)
Department Name: Malattie Autoimmuni Sistemiche
Principal Investigator Name: Lorenzo Beretta
Principal Investigator Email: lorenzo.beretta@policlinico.mi.it
Contact Person Name: Lorenzo Beretta
Contact Person Email: lorenzo.beretta@policlinico.mi.it

Sponsor

Primary sponsor

Full Name: Horizon Therapeutics Ireland Designated Activity Company
Organisation Type: Pharmaceutical company
Country Of Registered Address: Ireland

Contract research organisations

Name: PPD Global Ltd.
Responsibilities: Contract Research Organization, Clinical Database Management, Pharmacovigilance services in Greece

Name: PPD Development LP
Responsibilities: Contract Research Organization, Clinical Database Management, Pharmacovigilance services.

Name: Continuum Clinical LLC
Responsibilities: Patient recruitment and retention planning, study and site support, developing patient recruitment campaigns, and reporting and analytics.

Third parties

{"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Travel vendor, Make travel arrangements and/or provide Reimbursement services for approved Patient paid expenses for ground transportation and meal during travel to/from study visits and patient stipends for US and UK","organisation_type":"Non-Pharmaceutical company"}
{"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"IP Management and Depot","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central ultrasound reader","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Sjogren’s Foundation","duties_or_roles":"Investigator Training - Specifically, ESSDAI Assessment Training; developing patient recruitment materials (patient letters, physician letters and social media ads)","organisation_type":"Health care"}
{"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"Patient recruitment and retention planning, study and site support, developing patient recruitment campaigns, and reporting and analytics.","organisation_type":"Pharmaceutical company"}
{"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Contract Research Organization, Clinical Database Management, Pharmacovigilance services in Greece","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"PPD Development LP","duties_or_roles":"10","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"eCOA, ePRO and Patient Dairy","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: Dazodalibep
Active Substance: DAZODALIBEP
Modality: Peptide/protein/enzyme
Routes Of Administration: SOLUTION FOR INFUSION (intravenous infusion)
Route: Intravenous infusion
Authorisation Status: 1

Investigational Product Name: The placebo is formulated as sterile liquid intended for intravenous infusion following dilution in normal saline. The nominal volume in each vial is 5.0 mL. The placebo is aseptically filled into 6R glass vials, stoppered with a Flurotec-coated elastomeric stopper, and sealed with an aluminum overseal.
Modality: Other
Routes Of Administration: Intravenous infusion (placebo formulation)
Route: Intravenous infusion

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