Clinical trial • Phase III • Immunology

IANALUMAB for Sjögren's syndrome

Phase III trial of IANALUMAB for Sjögren's syndrome.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Sjögren's syndrome
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
07-06-2024
First CTIS Authorization Date
09-07-2024

Trial design

Randomised, vay736 (ianalumab) investigational arms and placebo to vay736 150 mg/1 ml solution for injection in pre-filled syringe (placebo comparator). specific active dose levels/schedules for vay736 are not stated in the provided record; placebo described as 'placebo to vay736 150 mg/1 ml solution for injection in pre-filled syringe'.-controlled Phase III trial in Sweden, Hungary, Italy and others.

Randomised
Yes
Comparator
VAY736 (ianalumab) investigational arms and Placebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe (placebo comparator). Specific active dose levels/schedules for VAY736 are not stated in the provided record; placebo described as 'Placebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe'.
Target Sample Size
345
Trial Duration For Participant
364

Eligibility

Recruits 345 Signed informed consent is required prior to participation. Multiple subject information and informed consent forms are provided (Main ICF - Adult; Molecular Pre-screening ICF; Genetics ICF; Follow up for pregnant participant; Follow up for pregnant partner; Info Sheet for Female Partner; Separate Data Protection Consent). Country-specific ICFs and language versions are available (examples: Hungarian, Swedish, Italian, Spanish, Polish, Slovak, French, Romanian, Greek, Bulgarian, German). A Parent/Legal Guardian ICF document is present in the submission set for France. The trial record indicates isVulnerablePopulationSelected: true; participant consent is obtained via the provided adult ICFs and additional, separate consent forms where applicable (e.g., genetics, data protection, pregnancy follow-up)..

Pregnancy Exclusion
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
Vulnerable Population
Signed informed consent is required prior to participation. Multiple subject information and informed consent forms are provided (Main ICF - Adult; Molecular Pre-screening ICF; Genetics ICF; Follow up for pregnant participant; Follow up for pregnant partner; Info Sheet for Female Partner; Separate Data Protection Consent). Country-specific ICFs and language versions are available (examples: Hungarian, Swedish, Italian, Spanish, Polish, Slovak, French, Romanian, Greek, Bulgarian, German). A Parent/Legal Guardian ICF document is present in the submission set for France. The trial record indicates isVulnerablePopulationSelected: true; participant consent is obtained via the provided adult ICFs and additional, separate consent forms where applicable (e.g., genetics, data protection, pregnancy follow-up).

Inclusion criteria

  • {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study\n- Patients taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day predniso(lo)ne or equivalent for at least 30 days before randomization. Stable dose should be maintained throughout the 52 weeks of the blinded treatment period of the study, however limited increases of the corticosteroid dose for a limited time and tapering of background steroids are allowed during the course of the study as described in Protocol Section 6.2.1\n- Patients taking: •\tdisease-modifying antirheumatic drugs (DMARDs) other than specifically allowed in inclusion criterion #9, or •\tthe following Traditional Chinese Medicines: Total glucoside of peony (TGP) or Tripterium glycosides (TG) must discontinue these medications at least 30 days prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.\n- Women and men ≥ 18 years of age\n- Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria (Shiboski et al 2017)\n- Time since diagnosis of Sjögren's of ≤ 7.5 years at screening\n- Positive anti-Ro/SSA antibody at screening: •\tPatients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review •\tEnrollment of anti-Ro/SSA-negative patients will be limited up to ≤10% of the study population\n- Screening ESSDAI score of ≥5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic.\n- Stimulated whole salivary flow (sSF) rate of ≥ 0.05 mL/min at screening\n- Ability to communicate well with the Investigator, understand and agree to comply with the requirements of the study\n- Patients taking hydroxychloroquine (≤ 400 mg/day), methotrexate (≤ 25 mg/week) or azathioprine (≤ 150 mg/day) alone or in combination are allowed to continue their medication and must have been on a stable dose for at least 30 days prior to randomization. Stable dose within the predefined dose limits should be maintained throughout the 52 weeks of the blinded treatment period of the study"}

Exclusion criteria

  • {"criterion_text":"- Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically: •\tModerate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSDAI domains •\tActive rheumatoid arthritis (RA) that impedes on the ability to score the ESSDAI articular domain •\tSystemic sclerosis •\tAny other concurrent connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's syndrome organ domain assessments.\n- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the subject. •\tHBsAg negative subjects who are hepatitis B core antibody (HBcAb) positive are also excluded unless all of the following criteria are met: o\tHBV DNA is negative o\thepatitis B monitoring is implemented - in these subjects monthly testing of HBsAg and HBV DNA must be performed while on study treatment and at least every 12 weeks after end of treatment for the entire duration of safety follow-up. o\tAntiviral prophylaxis must be implemented before the first administration of the study treatment and continued up to 12 months after end of study treatment. If antiviral therapy cannot be given or if the patient is not willing to comply with the antiviral treatment requirement, the patient is not eligible for the study. •\tHepatitis C: Patients with positive Hep C antibody and HCV RNA at screening are excluded. Chronic hepatitis C patients who have completed HCV anti-viral treatment must be HCV-RNA negative at least 12 weeks after treatment before randomization to be eligible. Cases of spontaneous HCV clearance should be discussed with sponsor before enrollment.\n- Evidence of active tuberculosis (TB) infection is exclusionary. Patient with previously treated TB and previously treated or newly diagnosed latent TB may be eligible (after anti-TB treatment, patients with history of or latent TB may become eligible according to national guidelines)\n- History of major organ, hematopoietic stem cell or bone marrow transplant.\n- Required regular use of medications known to cause dry mouth/eyes as regular and major side effect, and which have not been on a stable dose for at least 30 days prior to Screening, or any anticipated change in the treatment regimen during the course of the study.\n- Use of topical ocular prescription medications (excluding artificial tears, gels, lubricants) that have not been on a stable dose for at least 90 days prior to randomization, or any anticipated change in the treatment regimen during the course of the study.\n- Receipt of live/attenuated vaccine within a 4-week period prior to randomization.\n- History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) (ELISA and Western blot) test result.\n- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer or Sjögren’s related lymphoma), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n- History of sarcoidosis\n- Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes mellitus), psychiatric or additional physical condition that the Investigator feels may jeopardize the patient in case of participation in this study\n- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer, or longer if required by local regulations\n- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test\n- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational medication. Highly effective contraception methods include: •\tTotal abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. •\tFemale sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. •\tMale sterilization (at least 6 months prior to screening). For female participant on the study, the vasectomized male partner should be the sole partner for that participant. •\tUse of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Contraception should be used in accordance with locally approved prescribing information of concomitant medications administered. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate history of vasomotor symptoms). Women are considered not of child-bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).\n- Patients with a known history of non-compliance to medication, or who were unable or unwilling to complete PRO questionnaires, or who are unable or unwilling to use the device for collection of PROs\n- United States (and other countries, if locally required): Sexually active males, unless they agree to use barrier protection during intercourse with a woman of child-bearing potential, while taking study treatment. As condom use alone has a reported failure rate exceeding 1% per year, it is recommended that female partners of male study participants use a second method of birth control. Although ianalumab is not teratogenic and/or genotoxic, and not transferred to semen, male contraception is required, as requested by FDA. Globally, for all sexually active males, contraception should be used in accordance with locally approved prescribing information of concomitant medications administered.\n- Prior treatment with ianalumab\n- Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb) within 36 weeks prior to randomization or as long as B-cell count is less than the lower limit of normal or baseline value prior to receipt of previous B cell-depleting therapy (whichever is lower)\n- Prior treatment with any of the following: •\twithin 24 weeks prior to randomization: iscalimab (anti CD-40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v. (intravenous)/s.c.) plasmapheresis; •\twithin 12 weeks prior to randomization: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors) unless explicitly allowed in inclusion criterion #9\n- Use of corticosteroids (predniso(lo)ne or equivalent corticosteroid) at dose >10 mg/day\n- Any one of the following laboratory values at screening: •\tHemoglobin levels < 8.0 g/dL •\tWhite blood cells (WBC) count < 2.0 x 103/µL •\tPlatelet count < 80 x 103/µL •\tAbsolute neutrophil count (ANC) < 0.8 x 103/µL (one re-test is allowed during the screening period).\n- Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms.\n- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug (sucrose, L-histidine hydrochloride/ L-histidine, polysorbate 20)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary efficacy endpoint is change from baseline in ESSDAI score at week 48","definition_or_measurement_approach":"Change from baseline in ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) measured at Week 48 compared to baseline; superiority of ianalumab versus placebo based on this change."}

Secondary endpoints

  • {"endpoint_text":"- ESSDAI response at Week 48","definition_or_measurement_approach":"Proportion of patients achieving an ESSDAI response at Week 48."}
  • {"endpoint_text":"- Low systemic disease activity (ESSDAI < 5)","definition_or_measurement_approach":"Proportion of patients with ESSDAI score <5 at Week 48 (low systemic disease activity)."}
  • {"endpoint_text":"- ESSPRI response at Week 48","definition_or_measurement_approach":"ESSPRI response at Week 48 (patient-reported index); proportion or change from baseline as defined in study-specific endpoint definitions."}
  • {"endpoint_text":"- Changes from baseline in sSF at Week 48","definition_or_measurement_approach":"Change from baseline in stimulated whole salivary flow (sSF) rate at Week 48 (measured in mL/min)."}
  • {"endpoint_text":"- Changes from baseline in PhGA at Week 48","definition_or_measurement_approach":"Change from baseline in Physician's Global Assessment (PhGA) at Week 48."}
  • {"endpoint_text":"- Changes from baseline in PaGA at Week 48","definition_or_measurement_approach":"Change from baseline in Patient's Global Assessment (PaGA) at Week 48."}
  • {"endpoint_text":"- Changes from baseline in FACIT-F at Week 48","definition_or_measurement_approach":"Change from baseline in FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) score at Week 48."}
  • {"endpoint_text":"- SSSD response at Week 48","definition_or_measurement_approach":"Sjogren’s Syndrome Symptom Diary (SSSD) response at Week 48 (proportion of patients meeting response criteria)."}
  • {"endpoint_text":"- Change from baseline in ESSPRI score at Week 48","definition_or_measurement_approach":"Change from baseline in ESSPRI score at Week 48."}

Recruitment

Planned Sample Size
345
Recruitment Window Months
67
Consent Approach
Signed informed consent must be obtained prior to participation. Multiple, country- and language-specific informed consent documents are provided (main adult ICFs, molecular pre-screening ICF, genetics ICF, follow-up for pregnant participant and partner, info sheet for female partner, separate data protection consent). Local ICF versions exist for participating countries and languages as submitted.

Geography

Total Number Of Sites
51
Total Number Of Participants
150

Sweden

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
11
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Region Stockholm – SLSO
Department Name
4300:Centrum för reumatologi
Principal Investigator Name
Marika Kvarnström
Principal Investigator Email
marika.kvarnstrom@regionstockholm.se
Contact Person Name
Marika Kvarnström

Hungary

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
11
Number Of Sites
4
Number Of Participants
26

Sites

Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
2505: Szemeszeti Osztaly
Principal Investigator Name
Akos Vadnay
Principal Investigator Email
vadnayszemeszet@gmail.com
Contact Person Name
Akos Vadnay
Contact Person Email
vadnayszemeszet@gmail.com
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
2506: Infektologia hepatologia Oszt
Principal Investigator Name
Tibor Martyin
Principal Investigator Email
martyintibor@freemail.hu
Contact Person Name
Tibor Martyin
Contact Person Email
martyintibor@freemail.hu
Site Name
University Of Debrecen
Department Name
2503: III Belgyogyasztai Klinika
Principal Investigator Name
Antonia Szanto
Principal Investigator Email
szanto.antonia@med.unideb.hu
Contact Person Name
Antonia Szanto
Contact Person Email
szanto.antonia@med.unideb.hu
Site Name
Vita Verum Medical Bt.
Department Name
2504
Principal Investigator Name
Tunde Varga
Principal Investigator Email
vargatundedr1@gmail.com
Contact Person Name
Tunde Varga
Contact Person Email
vargatundedr1@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
17
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
2807: S.O.D. Clinica Medica
Principal Investigator Name
Gianluca Moroncini
Principal Investigator Email
g.moroncini@univpm.it
Contact Person Name
Gianluca Moroncini
Contact Person Email
g.moroncini@univpm.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
2805: U.O.C. Reumatologia D.A.I. Medicina Interna e Specialità Mediche
Principal Investigator Name
Fabrizio Conti
Principal Investigator Email
fabrizio.conti@uniroma1.it
Contact Person Name
Fabrizio Conti
Contact Person Email
fabrizio.conti@uniroma1.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
2803: S.O.C. Clinica di Reumatologia
Principal Investigator Name
Luca Quartuccio
Principal Investigator Email
luca.quartuccio@asufc.sanita.fvg.it
Contact Person Name
Luca Quartuccio
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
2800: S.C. Reumatologia
Principal Investigator Name
Cinzia Casu
Principal Investigator Email
cinzia.casu@ospedaleniguarda.it
Contact Person Name
Cinzia Casu
Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
2804: U.O. Day Hospital di Reumatologia
Principal Investigator Name
Nicoletta Del Papa
Principal Investigator Email
nicoletta.delpapa@asst-pini-cto.it
Contact Person Name
Nicoletta Del Papa
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
2801: U.O.C. Medicina interna e Immunologia Clinica
Principal Investigator Name
Amato De Paulis
Principal Investigator Email
depaulis@unina.it
Contact Person Name
Amato De Paulis
Contact Person Email
depaulis@unina.it
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
2802: U.O. Diagnosi e Terapia delle malattie allergiche e del sistema immunitario
Principal Investigator Name
Massimo Triggiani
Principal Investigator Email
mtriggiani@unisa.it
Contact Person Name
Massimo Triggiani
Contact Person Email
mtriggiani@unisa.it

Spain

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
12
Number Of Sites
7
Number Of Participants
19

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
4251:reumatología
Principal Investigator Name
Jose Andres Roman Ivorra
Principal Investigator Email
roman_jan@gva.es
Contact Person Name
Jose Andres Roman Ivorra
Contact Person Email
roman_jan@gva.es
Site Name
Hospital Universitario Reina Sofia
Department Name
4256:reumatología
Principal Investigator Name
Alejandro Escudero Contreras
Contact Person Name
Alejandro Escudero Contreras
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
4255:reumatología
Principal Investigator Name
Ricardo Blanco Alonso
Principal Investigator Email
ricardo.blanco@scsalud.es
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
4253:reumatología
Principal Investigator Name
Jose Maria Pego Reigosa
Principal Investigator Email
jose.maria.pego.reigosa@sergas.es
Contact Person Name
Jose Maria Pego Reigosa
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
4254:reumatología
Principal Investigator Name
Ivan Castellvi Barranco
Principal Investigator Email
ICastellvi@santpau.cat
Contact Person Name
Ivan Castellvi Barranco
Contact Person Email
ICastellvi@santpau.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
4252:reumatología
Principal Investigator Name
Belen Serrano Benavente
Principal Investigator Email
bserranob@salud.madrid.org
Contact Person Name
Belen Serrano Benavente
Contact Person Email
bserranob@salud.madrid.org
Site Name
Hospital Universitario Marques De Valdecilla (duplicate entry in list?)
Department Name
4255:reumatología
Principal Investigator Name
Ricardo Blanco Alonso
Principal Investigator Email
ricardo.blanco@scsalud.es
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es

Poland

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
26
Number Of Sites
5
Number Of Participants
28

Sites

Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
3554: NA
Principal Investigator Name
Małgorzata Socik-Pojawa
Principal Investigator Email
malgorzatasocikpojawa@medycynakliniczna.pl
Contact Person Name
Małgorzata Socik-Pojawa
Site Name
Pratia S.A.
Department Name
3555: NA
Principal Investigator Name
Mariusz Korkosz
Principal Investigator Email
mariusz.korkosz@pratia.com
Contact Person Name
Mariusz Korkosz
Contact Person Email
mariusz.korkosz@pratia.com
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
3551:Klinika Reumatologii i Chorób Wewnętrznych Oddział Kliniczny 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
Department Name
3552: NA
Principal Investigator Name
Maria Misterska-Skóra
Principal Investigator Email
maria.misterska-skora@cmoporow.com
Contact Person Name
Maria Misterska-Skóra
Site Name
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj
Department Name
3553: NA
Principal Investigator Name
Paweł Hrycaj
Principal Investigator Email
pawel.hrycaj@gmail.com
Contact Person Name
Paweł Hrycaj
Contact Person Email
pawel.hrycaj@gmail.com

Slovakia

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
11
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
Reum.hapi s.r.o.
Department Name
4000: Reumatologická ambulancia
Principal Investigator Name
Marianna Hauptvoglova
Principal Investigator Email
hauptvoglova.reumhapi@gmail.com
Contact Person Name
Marianna Hauptvoglova
Site Name
Albamed s.r.o.
Department Name
4001: Reumatologická ambulancia
Principal Investigator Name
Silvia Ciernik
Principal Investigator Email
silvia.ciernik@gmail.com
Contact Person Name
Silvia Ciernik
Contact Person Email
silvia.ciernik@gmail.com
Site Name
Univerzitna nemocnica Nemocnica svaeteho Michala a.s.
Department Name
4004: Reumatologická ambulancia
Principal Investigator Name
Lenka Tarabcakova
Principal Investigator Email
lenka.tarabcakova@gmail.com
Contact Person Name
Lenka Tarabcakova
Contact Person Email
lenka.tarabcakova@gmail.com
Site Name
REUMACENTRUM s.r.o.
Department Name
4007: Reumatologická ambulancia
Principal Investigator Name
Livia Bruskova
Principal Investigator Email
bruskovalivia@gmail.com
Contact Person Name
Livia Bruskova
Contact Person Email
bruskovalivia@gmail.com
Site Name
Artromac N.O.
Department Name
4003: Reumatologická ambulancia
Principal Investigator Name
Michaele Zarikova
Principal Investigator Email
m.zarikova@gmail.com
Contact Person Name
Michaele Zarikova
Contact Person Email
m.zarikova@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
12
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
2355: Rheumatologie, Medizinische Klinik III
Principal Investigator Name
Anne-Kathrin Tausche-Wunderlich
Contact Person Name
Anne-Kathrin Tausche-Wunderlich
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
2351: Rheumazentrum Ruhrgebiet
Principal Investigator Name
Ioana Andreica
Principal Investigator Email
Ioana.andreica@elisabethgruppe.de
Contact Person Name
Ioana Andreica
Site Name
Immanuel-Krankenhaus GmbH
Department Name
2353: Abteilung Rheumatologie und Klinische Immunologie
Principal Investigator Name
Andreas Krause
Principal Investigator Email
Andreas.krause@immanuelalbertinen.de
Contact Person Name
Andreas Krause
Site Name
Medizinische Hochschule Hannover
Department Name
5354:Klinik für Rheumatologie und Immunologie
Principal Investigator Name
Torsten Witte
Principal Investigator Email
witte.torsten@mh-hannover.de
Contact Person Name
Torsten Witte
Contact Person Email
witte.torsten@mh-hannover.de
Site Name
University Hospital Cologne AöR
Department Name
2356: Klinik I für Innere Medizin
Principal Investigator Name
Philipp Koehler
Principal Investigator Email
philipp.koehler@uk-koeln.de
Contact Person Name
Philipp Koehler
Contact Person Email
philipp.koehler@uk-koeln.de

Romania

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
11-07-2024
Processing Time Days
13
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Department Name
3701: Rheumatology
Principal Investigator Name
Liliana Duca
Principal Investigator Email
liliduca@neomed.org
Contact Person Name
Liliana Duca
Contact Person Email
liliduca@neomed.org
Site Name
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Department Name
3708: Rheumatology
Principal Investigator Name
Ciprian Jurcut
Principal Investigator Email
cjurcut@gmail.com
Contact Person Name
Ciprian Jurcut
Contact Person Email
cjurcut@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
3700: Rheumatology
Principal Investigator Name
Simona Rednic
Principal Investigator Email
srednic@umfcluj.ro
Contact Person Name
Simona Rednic
Contact Person Email
srednic@umfcluj.ro
Site Name
Saint Maria Hospital
Department Name
3705: Rheumatology
Principal Investigator Name
Andra Rodica Balanescu
Principal Investigator Email
balanescu.andra@gmail.com
Contact Person Name
Andra Rodica Balanescu
Contact Person Email
balanescu.andra@gmail.com
Site Name
Medaudio-Optica S.R.L.
Department Name
3704: Rheumatology
Principal Investigator Name
Razvan Ionitescu
Principal Investigator Email
razvan1us@yahoo.com
Contact Person Name
Razvan Ionitescu
Contact Person Email
razvan1us@yahoo.com

Greece

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
2101: 4th Internal Medicine Clinic
Principal Investigator Name
Theodoros Dimitroulas
Principal Investigator Email
dimitroul@hotmail.com
Contact Person Name
Theodoros Dimitroulas
Contact Person Email
dimitroul@hotmail.com
Site Name
Hippokration Hospital
Department Name
2100:2nd Internal Medicine Clinic
Principal Investigator Name
Dimitrios Vassilopoulos
Principal Investigator Email
dvassilop@med.uoa.gr
Contact Person Name
Dimitrios Vassilopoulos
Contact Person Email
dvassilop@med.uoa.gr
Site Name
Athens Naval Hospital
Department Name
2102: Rheumatology Clinic
Principal Investigator Name
Gkikas Katsifis
Principal Investigator Email
katsifisg@yahoo.gr
Contact Person Name
Gkikas Katsifis
Contact Person Email
katsifisg@yahoo.gr

France

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
11-07-2024
Processing Time Days
13
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
2252 : Service de Rhumatologie
Principal Investigator Name
Christophe Richez
Principal Investigator Email
christophe.richez@chu-bordeaux.fr
Contact Person Name
Christophe Richez
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
2255 : Service de Rhumatologie
Principal Investigator Name
Christian Lavigne
Principal Investigator Email
chlavigne@chu-angers.fr
Contact Person Name
Christian Lavigne
Contact Person Email
chlavigne@chu-angers.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
2253 : Service de Rhumatologie
Principal Investigator Name
Jacques-Eric Gottenberg
Principal Investigator Email
jacques-eric.gottenberg@chru-strasbourg.fr
Contact Person Name
Jacques-Eric Gottenberg
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
2254 : Service de Rhumatologie
Principal Investigator Name
Valerie Devauchelle Pensec
Principal Investigator Email
valerie.devauchelle-pensec@chu-brest.fr
Contact Person Name
Valerie Devauchelle Pensec
Site Name
Centre Hospitalier Le Mans
Department Name
2251 : Service de Rhumatologie
Principal Investigator Name
Paul Legendre
Principal Investigator Email
plegendre@ch-lemans.fr
Contact Person Name
Paul Legendre
Contact Person Email
plegendre@ch-lemans.fr
Site Name
Bicetre Hospital
Department Name
2256 : Service de Rhumatologie
Principal Investigator Name
Xavier Mariette
Principal Investigator Email
chlavigne@chu-angers.fr
Contact Person Name
Xavier Mariette
Contact Person Email
chlavigne@chu-angers.fr

Bulgaria

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
12-07-2024
Processing Time Days
14
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Military Medical Academy
Department Name
1501 : Rheumatology department
Principal Investigator Name
Boycho Oparanov
Principal Investigator Email
oparanov@abv.bg
Contact Person Name
Boycho Oparanov
Contact Person Email
oparanov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Burgas AD
Department Name
1502 : Rheumatology department
Principal Investigator Name
Ivan Kazmin
Principal Investigator Email
ivnikaz@yahoo.com
Contact Person Name
Ivan Kazmin
Contact Person Email
ivnikaz@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
1503 : Rheumatology clinic
Principal Investigator Name
Anastas Batalov
Principal Investigator Email
abatalov@hotmail.com
Contact Person Name
Anastas Batalov
Contact Person Email
abatalov@hotmail.com

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
code 1
Name
IQVIA RDS Spain S.L.
Responsibilities
code 1
Name
IQVIA RDS, Inc.
Responsibilities
Randomization of patients, management of drug supply logistics, dispensing and unblinding; code 3
Name
Icon Clinical Research Limited
Responsibilities
code 1
Name
Parexel International (IRL) Limited
Responsibilities
code 12
Name
Syneos Health Inc.
Responsibilities
code 1
Name
Syneos Health Clinical Spain S.L.
Responsibilities
code 1
Name
Rps Research Iberica S.L.
Responsibilities
code 1

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Storage of blood for biomarker analysis and storage of blood PK samples","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"IQVIA RDS Spain S.L.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Auto-antibodies (connective profile panel)","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Ancillary supply","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"ApoEx AB","duties_or_roles":"Pharmaceutical control, drug distribution, relabelling, and destruction of IMP","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"PRO formatting, translations, and licensing of ePROs","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local drug supply and Local equipment storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Rps Research Iberica S.L.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"Patients Reported Outcomes management, data collection via tablet","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Cambridge Cognition Limited","duties_or_roles":"Data collection for DSST and digital sub study","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Eco-Abc Sp. z o. o. (second entry duplicate)","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"IQVIA RDS, Inc.","duties_or_roles":"Randomization of patients, management of drug supply logistics, dispensing and unblinding; code 3","organisation_type":"Industry"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Home nursing service administration","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Syneos Health Clinical Spain S.L.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"ApoEx AB (duplicate)","duties_or_roles":"Pharmaceutical control, drug distribution, relabelling, and destruction of IMP","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited (duplicate)","duties_or_roles":"Ancillary supply","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Cambridge Cognition Limited (duplicate)","duties_or_roles":"Data collection for DSST and digital sub study","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
VAY736
Active Substance
IANALUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
Marketing authorisation status: prodAuthStatus 1
Maximum Dose
300 mg
Investigational Product Name
Placebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe
Modality
Other
Starting Dose
placebo matching VAY736 150 mg/1 mL (as labelled)
Investigational Product Name
- (auxiliary: glucocorticoids product record)
Active Substance
-
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 2
Maximum Dose
50 mg

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