Clinical trial • Phase II • Immunology

OBEXELIMAB for Systemic Lupus Erythematosus

Phase II trial of OBEXELIMAB for Systemic Lupus Erythematosus.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic Lupus Erythematosus
Trial Stage
Phase II
Drug Modality
Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
13-06-2024
First CTIS Authorization Date
07-10-2024

Trial design

Randomised, placebo sterile solution for sc injection - one sc injection every 7 days during 24-week treatment period (placebo arm). investigational arm: obexelimab - one sc injection every 7 days during 24-week treatment period.-controlled Phase II trial in Germany, Italy, Greece and others.

Randomised
Yes
Comparator
Placebo sterile solution for SC injection - one SC injection every 7 days during 24-week treatment period (placebo arm). Investigational arm: Obexelimab - one SC injection every 7 days during 24-week treatment period.
Target Sample Size
111
Trial Duration For Participant
252

Eligibility

Recruits 111 The trial indicates 'isVulnerablePopulationSelected': true. Inclusion criteria require participants to be capable of giving signed informed consent. Subject information and informed consent forms (ICFs) and related ICF variants (e.g., Pregnancy ICF, Pregnancy and Newborn ICF, Caregiver ICF) are provided in multiple country/language versions. Caregiver ICF documents are present for some countries, indicating provisions for caregiver consent where relevant. No explicit assent procedures for minors are provided (participants must be ≥18)..

Pregnancy Exclusion
7. Female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5. OR b) A WOCBP who meets all of the following: - Agrees to either sexual abstinence or use of contraception (as detailed in Appendix 5) until at least 8 weeks after the last administration of IMP. - Has a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1 prior to the first dose of IMP. - Agrees to refrain from egg donation until at least 8 weeks after the last dose of IMP.
Vulnerable Population
The trial indicates 'isVulnerablePopulationSelected': true. Inclusion criteria require participants to be capable of giving signed informed consent. Subject information and informed consent forms (ICFs) and related ICF variants (e.g., Pregnancy ICF, Pregnancy and Newborn ICF, Caregiver ICF) are provided in multiple country/language versions. Caregiver ICF documents are present for some countries, indicating provisions for caregiver consent where relevant. No explicit assent procedures for minors are provided (participants must be ≥18).

Inclusion criteria

  • {"criterion_text":"- 1. ≥ 18 to ≤ 70 years of age.\n- 2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.\n- 3. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria.\n- 4. At screening, at least one of the following: a) anti-nuclear antibody (ANA) ≥ 1:80 b) positive anti-dsDNA c) positive anti-Sm\n- 5. Patient has all 3 of the following based on features active on the day of the visits: a) hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1. Note: Clinical points exclude laboratory tests, except proteinuria. Patients with proteinuria scored as present (i.e., urine protein/creatinine > 500 mg/g) at screening will also be scored as present on Day 1 if a dipstick performed at the site on Day 1 is at least 2+ proteinuria. If the urine protein/creatinine > 500 mg/g at screening is not known to be stable based on recent past proteinuria testing, then a repeat urine protein/creatinine measurement is required during the Screening Period. b) BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1. c) In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent.\n- 6. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant. The treatment regimen must be as below: a) If taking oral corticosteroid: No increase in dosing regimen during the Screening Period, and at stable dose ≤ 20 mg/day prednisone-equivalent at least 2 weeks prior to Day 1. b) If taking antimalarial: - No dose increase within 8 weeks prior to the Screening visit. - After the Screening visit (i.e., during the Screening Period and the Treatment Period), dosing must be stable and as follows: hydroxychloroquine ≤ 400 mg/day, quinacrine ≤ 100 mg/day, or chloroquine ≤ 250 mg/day. c) If taking immunosuppressant: - No dose increase within 8 weeks prior to the Screening visit. - After the Screening visit (i.e., during the Screening period and the Treatment period), must be taking no more than 1 immunosuppressant and at a stable dose as follows: mycophenolate mofetil ≤ 3 g/day, mycophenolate sodium ≤ 2160 mg/day, azathioprine ≤ 200 mg/day, 6- mercaptopurine ≤ 100 mg/day, methotrexate ≤ 25 mg/week, cyclosporine ≤ 2 mg/kg/day, tacrolimus ≤ 3 mg/day, or voclosporin ≤ 23.7 mg twice daily.\n- 7. Female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5. OR b) A WOCBP who meets all of the following: - Agrees to either sexual abstinence or use of contraception (as detailed in Appendix 5) until at least 8 weeks after the last administration of IMP. - Has a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1 prior to the first dose of IMP. - Agrees to refrain from egg donation until at least 8 weeks after the last dose of IMP.\n- 8. A male patient is eligible if the following conditions apply: - Agrees to either sexual abstinence or use of contraception (as detailed in Appendix 5) until at least 8 weeks after the last dose of IMP or is surgically sterile. AND Agrees to refrain from donating sperm until at least 8 weeks after the last dose of IMP."}

Exclusion criteria

  • {"criterion_text":"- Patients are excluded from the study if any of the following criteria apply: 1. Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient’s safety or additional therapy that is not permitted in the protocol is needed.\n- 10. Malignancy within 5 years except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin.\n- 11. History of drug or alcohol abuse in the previous 12 months before screening in the opinion of the investigator.\n- 12. Use prior to screening of one or more of the following: a) Within 6 months: rituximab or similar major B cell-depleting biologic therapy, or T cell-depleting agent such as Campath (alemtuzumab). Note: Patients who received B-cell-targeted therapy > 6 and ≤ 12 months prior to randomization must have a B-cell count that is within the laboratory reference range at screening, as measured by the central laboratory. b) Within 1 month: belimumab or any inhibitor of B cell activating factor (BAFF) and/or APRIL, anifrolumab, abatacept, infliximab, adalimumab, certolizumab, golimumab, etanercept, tocilizumab, anakinra, immunoglobulin, blood products, cyclophosphamide IV or oral, live or live-attenuated vaccine, or other biologics with immunomodulating/immunosuppressive activity. c) Within 5 half-lives or 30 days, whichever is longer: any investigational drug.\n- 13. Use after the Screening visit of medical treatment (including prescription drugs, non-prescription drugs, biological products, Chinese or herbal medicines, diet supplements, etc.) or health care products considered by the investigator or central adjudicator to potentially impact the interpretation of study results.\n- 14. Currently enrolled in another interventional clinical study. Note: Patients enrolled in ongoing cohort or non-interventional studies may not donate blood or tissue samples for such studies during their participation in this study (including the Follow-up Period). All the other exclusion criteria can be found in the protocol (section 5.2.2).\n- 2. A history of thrombosis or embolism in the previous 6 months before the Screening visit, or thrombotic history in the previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state. A thrombotic history associated with APS or another relevant hypercoagulable state more than 12 months prior to Screening visit is excluded if it is not treated per local standards with prophylactic anticoagulation.\n- 3. Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE, such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis.\n- 4. Active severe neuropsychiatric or CNS SLE.\n- 5. Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator. Current diagnosis of thyroiditis or secondary Sjogren's Syndrome is permitted.\n- 6. Presence of uncontrolled or New York Heart Association Class III or IV congestive heart failure.\n- 7. Any condition or finding on physical exam, current or previous medical history, vital signs, 12-lead ECG, or laboratory tests that, in the opinion of the investigator or central adjudicator, might interfere with the evaluation of the investigational product or should otherwise exclude a patient.\n- 8. Surgery (not considered minor by the investigator or the central adjudicator) within 4 weeks before Screening, or planned surgery during the study.\n- 9. History of relevant allergies, including allergy to study drug or any murine or human-derived protein or immunoglobulin products that, in the opinion of the investigator or central adjudicator, make inclusion in the study inappropriate."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of patients who achieve a response at Week 24, defined according to the BILAGBased Composite Lupus Assessment (BICLA) Response","definition_or_measurement_approach":"Response measured at Week 24 according to the BILAG-Based Composite Lupus Assessment (BICLA) response (proportion of patients achieving BICLA response at Week 24)."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 24","definition_or_measurement_approach":"Proportion of patients achieving SRI-4 response at Week 24."}
  • {"endpoint_text":"- Proportion of patients who achieve Lupus Low Disease Activity State (LLDAS) at Week 24.","definition_or_measurement_approach":"Proportion of patients meeting LLDAS criteria at Week 24."}
  • {"endpoint_text":"- Time to flare","definition_or_measurement_approach":"Time from baseline to disease flare (as defined in protocol) measured over study period."}
  • {"endpoint_text":"- Proportion of patients achieving prednisone equivalent dose ≤ 5 mg/day by the Week 12 visit and maintained through Week 24 with no disease worsening","definition_or_measurement_approach":"Proportion achieving and maintaining prednisone-equivalent ≤5 mg/day by Week 12 through Week 24 without disease worsening."}
  • {"endpoint_text":"- Proportion of patients who achieve a ≥ 50% improvement from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score (CLASI-50 response) at Week 24 compared with baseline","definition_or_measurement_approach":"Proportion achieving ≥50% improvement in CLASI-A (CLASI-50) at Week 24 vs baseline."}
  • {"endpoint_text":"- Proportion of patients who achieve ≥ 50% decrease in active joint count (Joint-50 response) at Week 24 compared with baseline","definition_or_measurement_approach":"Proportion achieving ≥50% decrease in active joint count at Week 24 vs baseline."}
  • {"endpoint_text":"- Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 24","definition_or_measurement_approach":"Change from baseline in FACIT-Fatigue score at Week 24."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
111
Recruitment Window Months
18
Consent Approach
Participants must be capable of giving signed informed consent (ICF). Subject information and ICF documents are provided in multiple languages and country-specific versions; pregnancy and newborn ICFs and caregiver ICFs are available. Consent is provided by the participant (adult ≥18). Caregiver ICFs are available where applicable. ICF language versions present in the public documents include German, Italian, Greek, Portuguese, Spanish, Romanian, English, Polish, Bulgarian, Dutch and French (country-specific ICFs listed in the documentation).

Methods

  • HCP referral letters (channel: healthcare professionals) - country-specific versions present (e.g., DE, IT, PT, GR, ES, PL, BG, BE).
  • Study website layout and study-website text (channel: online/study website) - country/language-specific versions available.
  • Printed study introduction/trifold and brochures (channel: print materials for patients) - country-specific versions (e.g., DE, IT, PT, GR, ES, PL, BG, BE).
  • Understanding Your Study / 'Understanding Your Study' booklets and illustrative materials (patient-facing educational material) - country-specific.
  • PFS (patient-facing support) Complete IFU and 2D animation illustration boards (channel: multimedia educational/IFU materials).
  • Direct-to-Patient (DTP) instructions and World Courier DTP materials (channel: direct shipment/logistics to patients/sites) - global/ROW materials present.
  • Clincierge participant materials (travel guidance, pay portal guidance, privacy notes) (channel: participant support services).
  • FirmaCares brochure template (DE) (channel: patient support/provider) - country-specific vendor materials.

Geography

Total Number Of Sites
40
Total Number Of Participants
91

Germany

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
14-05-2025
Processing Time Days
257
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Medicover GmbH
Contact Person Name
David Kofler
Contact Person Email
david.kofler@medicover.de
Site Name
University Hospital Cologne AöR
Department Name
Med. Klinik 1 für Innere Medizin Immunologische Ambulanz
Contact Person Name
Philipp Köhler

Italy

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
08-05-2025
Processing Time Days
315
Number Of Sites
7
Number Of Participants
4

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC di Reumatologia
Contact Person Name
Marta Mosca
Contact Person Email
marta.mosca@med.unipi.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinical Rheumatology, Department of Internal Medicine
Contact Person Name
Alberto Sulli
Contact Person Email
albertosulli@unige.it
Site Name
University Hospital Of Ferrara
Department Name
UO di Reumatologia
Contact Person Name
Marcello Govoni
Contact Person Email
gvl@unife.it
Site Name
Azienda Sanitaria Locale Citta Di Torino
Department Name
CMID-SCDU Nefrologia e Dialisi
Contact Person Name
Savino Sciascia
Contact Person Email
savino.sciascia@unito.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Department of Medicine, Rheumatology Unit
Contact Person Name
Giovanni Orsolini
Contact Person Email
giovanniorsolini@univr.it
Site Name
Universita' Campus Bio-medico Di Roma
Department Name
UOC di Immunoreumatologia
Contact Person Name
Roberto Giacomelli
Contact Person Email
r.giacomelli@unicampus.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unit of Immunology, Rheumatology, Allergy and Rare diseases
Contact Person Name
Lorenzo Dagna
Contact Person Email
dagna.lorenzo@unisr.it

Greece

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
23-05-2025
Processing Time Days
240
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Asklepieion Voulas General Hospital
Department Name
Rheumatology Department
Contact Person Name
Antonia Elezoglou
Contact Person Email
taniaelezoglou@gmail.com
Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
4th Department of Internal Medicine, Rheumatology Clinic
Contact Person Name
Theodoros Dimitroulas
Contact Person Email
imitroul@hotmail.com
Site Name
Euromedica Kyanous Stavros
Department Name
Rheumatology Department
Contact Person Name
Lucas Settas
Contact Person Email
loukassettas@gmail.com
Site Name
Olympion Therapeftirio General Clinic Of Patras S.A.
Department Name
Rheumatology Department
Contact Person Name
Andreas Bounas
Contact Person Email
andbounas@gmail.com
Site Name
University General Hospital Attikon
Department Name
4th Department of Internal Medicine
Contact Person Name
Dimitrios Boumpas
Contact Person Email
boumpasd@uoc.gr
Site Name
University General Hospital Of Heraklion
Department Name
Clinic of Rheumatology and Clinical Immunology
Contact Person Name
Prodromos Sidiropoulos
Contact Person Email
sidiropp@med.uoc.gr

Portugal

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
05-05-2025
Processing Time Days
224
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Centro Hospitalar de Setubal E.P.E.
Department Name
Internal Medicine
Contact Person Name
Daniela Brigas
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Rheumatology
Contact Person Name
Carina Lopes
Contact Person Email
calopes@chlo.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Rheumatology
Contact Person Name
Nikita Khmelinskii
Contact Person Email
nkhmelinskii@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
26-05-2025
Processing Time Days
333
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Department Name
Allergology-Immunology, Rheumatology Department
Contact Person Name
Liliana Duca
Contact Person Email
liliduca@neomed.org
Site Name
Spitalul Clinic Dr. I. Cantacuzino
Department Name
Clinical Internal Medicine and Rheumatology
Contact Person Name
Ana Maria Gheorghiu
Contact Person Email
ana.gherghe@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
03-06-2025
Processing Time Days
270
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
RHUMATOLOGY
Contact Person Name
Christian von Frenckell
Contact Person Email
cvonfrenckell@chuliege.be
Site Name
UZ Leuven
Department Name
Rhumatology
Contact Person Name
Ellen Langhe
Contact Person Email
ellen.delanghe@uzleuven.be

Bulgaria

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
08-05-2025
Processing Time Days
241
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
Department Name
Department internal diseases
Contact Person Name
Dimitar Penev
Contact Person Email
d_penev@hotmail.com
Site Name
Medical Center Medtech Services Ltd.
Contact Person Name
Krasimir Kraev
Contact Person Email
dr_k.kraev@abv.bg
Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Vladimira Boyadzhieva

Denmark

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
314
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Region Sjaelland
Department Name
Reumatologisk afdeling
Contact Person Name
Ada Colic
Contact Person Email
adco@regionsjaelland.dk

Spain

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
08-08-2025
Processing Time Days
366
Number Of Sites
6
Number Of Participants
7

Sites

Site Name
Futuremeds Spain S.L.
Department Name
Rheumatology
Contact Person Name
Karin Freitag
Contact Person Email
doctorakarinfreitag@dkf.es
Site Name
Futuremeds Spain S.L.
Department Name
Rheumatology
Contact Person Name
Jacqueline Uson Jaeger
Contact Person Email
Jacqueline.uson@futuremeds.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Rheumatology
Contact Person Name
José Salvador García Morillo
Contact Person Email
salvaymar@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Rheumatology
Contact Person Name
Fernando Martínez Valle
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Rheumatology
Contact Person Name
Andrés González García
Site Name
Hospital Universitario La Paz
Department Name
Medicina Interna
Contact Person Name
Juan José Ríos Blanco
Contact Person Email
juanj.rios@salud.madrid.org

Poland

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
23-09-2025
Processing Time Days
382
Number Of Sites
8
Number Of Participants
31

Sites

Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Bydgoszcz
Contact Person Name
Katarzyna Kolossa
Contact Person Email
k.kolossa@naszlekarz.pl
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Contact Person Name
Magdalena Celińska-Löwenhoff
Contact Person Email
trials@plejady.com.pl
Site Name
Prywatna Praktyka Lekarska Prof Dr Hab Med Paweł Hrycaj
Contact Person Name
Paweł Hrycaj
Contact Person Email
pawel.hrycaj@gmail.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Oddział Kliniczny Nefrologii i Chorób Wewnętrznych
Contact Person Name
Ilona Kurnatowska
Contact Person Email
ilona.kurnatowska@umed.lodz.pl
Site Name
Krakowskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Przemysław Borowy
Site Name
Somed Cr Sp. z o.o. sp.k.
Department Name
Somed CR
Contact Person Name
Tomasz Budlewski
Contact Person Email
tomasz.budlewski@somed.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Warszawa
Contact Person Name
Małgorzata Gryka- Marton
Contact Person Email
mgrykamarton@gmail.com
Site Name
Pracownia Badań Klinicznych Salus
Contact Person Name
Katarzyna Rachwał-Siek

Sponsor

Primary sponsor

Full Name
Zenas Biopharma (USA) LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Pharmaceutical Product Development LLC (PPD Development LP / PPD Development)
Responsibilities
Multiple sponsorDuties including codes 1,11,12,13,2,4,5,6,8,9 (various trial operational roles as listed in sponsorDuties).
Name
PPD Global Central Labs
Responsibilities
sponsorDuties code: 4
Name
PPD Global Ltd.
Responsibilities
Project management duties or monitoring/regulatory (sponsorDuties code: 15)
Name
Almac Diagnostic Services LLC
Responsibilities
sponsorDuties code: 4
Name
PCI Pharma Services Germany GmbH
Responsibilities
sponsorDuties code: 14
Name
Suvoda LLC
Responsibilities
sponsorDuties code: 3
Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties code: 7

Third parties

  • {"country":"United States","full_name":"Almac Diagnostic Services LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Inato","duties_or_roles":"Feasibility (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Olink Proteomics Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Dxterity Diagnostics Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1,11,12,13,2,4,5,6,8,9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Study Branding and printing materials (sponsorDuties code: 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Project management duties or monitoring/regulatory (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Obexelimab
Active Substance
OBEXELIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
EU MP number PRD9993985; prodAuthStatus: 1
Orphan Designation
Yes
Frequency
One SC injection every 7 days during 24-week treatment period
Maximum Dose
Max daily dose amount 250 mg; max total dose amount 6000 mg
Investigational Product Name
Placebo sterile solution for SC injection
Modality
Other
Frequency
One SC injection every 7 days during 24-week treatment period (placebo arm)

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