Clinical trial • Phase II • Neurology

OBEXELIMAB for Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Secondary progressive multiple sclerosis (active)

Phase II trial of OBEXELIMAB for Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Secondary progressive multiple sclerosis (active).

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Secondary progressive multiple sclerosis (active)
Trial Stage
Phase II
Drug Modality
Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
06-06-2024
First CTIS Authorization Date
27-09-2024

Trial design

Randomised, open-label, placebo sterile solution for sc injection administered subcutaneously once weekly (placebo control arm matched to obexelimab 250 mg sc qw). Phase II trial across 26 sites in Finland, Denmark, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo sterile solution for SC injection administered subcutaneously once weekly (placebo control arm matched to obexelimab 250 mg SC QW).
Target Sample Size
52
Trial Duration For Participant
532

Eligibility

Recruits 52 Vulnerable population flag selected (isVulnerablePopulationSelected = true). Participants must be capable of giving signed informed consent (Inclusion criterion 1). Country-specific informed consent forms and caregiver ICFs are provided (multiple 'Main-ICF' and 'Caregiver-ICF' documents in local languages). No paediatric assent procedures (trial enrolment restricted to adults ≥18 years)..

Pregnancy Exclusion
6. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 until at least 8 weeks after the last administration of IMP AND c. Has a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1 prior to the first dose of IMP AND d. Agrees to refrain from egg donation until at least 8 weeks after the last administration of IMP
Vulnerable Population
Vulnerable population flag selected (isVulnerablePopulationSelected = true). Participants must be capable of giving signed informed consent (Inclusion criterion 1). Country-specific informed consent forms and caregiver ICFs are provided (multiple 'Main-ICF' and 'Caregiver-ICF' documents in local languages). No paediatric assent procedures (trial enrolment restricted to adults ≥18 years).

Inclusion criteria

  • {"criterion_text":"- 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF"}
  • {"criterion_text":"- 2. Male or female, ≥ 18 to ≤ 60 years of age, inclusive, at the time of signing the ICF"}
  • {"criterion_text":"- 3. Diagnosis of RMS (relapsing-remitting or active secondary progressive) according to the 2017 revision of the McDonald diagnostic criteria"}
  • {"criterion_text":"- 4. An EDSS of ≤ 5.5 at the Screening Visit"}
  • {"criterion_text":"- 5. Must have documentation of: a. at least 1 relapse within the previous year OR b. ≥ 2 relapses within the past 2 years OR c. ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening"}
  • {"criterion_text":"- 6. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 until at least 8 weeks after the last administration of IMP AND c. Has a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1 prior to the first dose of IMP AND d. Agrees to refrain from egg donation until at least 8 weeks after the last administration of IMP"}
  • {"criterion_text":"- 7. A male patient must: a. Agree to either (i) abstain from intercourse or (ii) use contraception (as detailed in Appendix 4) until at least 8 weeks after the last administration of IMP, or (iii) be surgically sterile for the duration of the study AND b. Agree to refrain from donating sperm until at least 8 weeks after the last administration of IMP"}

Exclusion criteria

  • {"criterion_text":"- 1. Primary progressive MS or inactive secondary progressive MS"}
  • {"criterion_text":"- 11. Has received treatment with intravenous immunoglobulins, plasmapheresis or natalizumab (patients who stop getting infusions within 6 months prior to randomization should be ruled out for progressive multifocal leukoencephalopathy) within 2 months prior to randomization. Has received sphingosine 1-phosphate receptor modulator treatment within 5 half-lives of the treatment or until the end of its pharmacodynamic activity, or whichever is longer, prior to randomization (for example; Ponesimod [Ponvory®]: 2 weeks, Siponimod [Mayzent®]: 1 month, Fingolimod [Gilenya®]: 2 months, Fingolimod oral disintegrating tablets [ODT] [Tascenso ODT®]: 2 months, Ozanimod [Zeposia®]: 3 months)"}
  • {"criterion_text":"- 26. Hypersensitivity to dextran or components of dextran or any component of the study drug and placebo, including excipients"}
  • {"criterion_text":"- 4. ≥ 10 years disease duration from onset with patient’s EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)"}
  • {"criterion_text":"- 10. Has received treatment with B-interferons or glatiramer acetate within 1 month prior to randomization"}
  • {"criterion_text":"- 14. Has received cladribine, cyclophosphamide, alemtuzumab, or mitoxantrone within 2 years prior to randomization"}
  • {"criterion_text":"- 21. Malignancy within 5 years except successfully treated in situ cervical cancer, resected squamous cell carcinoma, or basal cell carcinoma of the skin"}
  • {"criterion_text":"- 19. Acute hepatitis B infection (hepatitis B surface antigen-positive), active hepatitis C virus, or HIV infection. Patients will be excluded from the study if they have a positive test for active hepatitis B through detection of (a) hepatitis B surface antigen or (b) hepatitis B core antibody. Patients with active, chronic, or uncured HBV will be excluded."}
  • {"criterion_text":"- 2. Meet criteria for neuromyelitis optica spectrum disorder"}
  • {"criterion_text":"- 3. Relapse in the 30 days prior to randomization"}
  • {"criterion_text":"- 24. History or evidence of a clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, oncologic, renal, hepatic, metabolic, hematologic, psychiatric, active infection) other than RMS that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion"}
  • {"criterion_text":"- 25. Any known allergy to mAb therapy"}
  • {"criterion_text":"- 27. Inability to comply with MRI scanning or MRI contrast administration"}
  • {"criterion_text":"- 16. Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or < 5 half-lives of the investigational treatment, whichever is longer prior to randomization"}
  • {"criterion_text":"- 20. Evidence of active tuberculosis (TB) or at high risk for TB as shown by at least one of the following: a. Documented history of active TB or latent TB, unless completion of treatment according to local guidelines b. Positive, indeterminate, or invalid interferon-gamma release assay results at screening, unless treatment is documented. Patients with an indeterminate test result can repeat the test once either centrally or locally, but if the repeat test is also indeterminate, the patient is excluded c. Signs or symptoms that could represent active TB d. Chest radiograph, computed tomography, or MRI that suggests possible diagnosis of TB"}
  • {"criterion_text":"- 5. Has > 20 Gd+ lesions on brain MRI at screening"}
  • {"criterion_text":"- 6. Prior use of B cell–depleting agents"}
  • {"criterion_text":"- 22. Hematology or clinical chemistry parameters that meet any of the following criteria at screening: a. White blood cell count < 3.5 × 10^3/μL b. Absolute neutrophil count < 1.5 × 10^3/μL c. Elevated serum creatinine > 2.5 × upper limit of normal (ULN) OR estimated creatinine clearance < 40 mL/min calculated by the Cockcroft-Gault formula at screening d. Hemoglobin < 10 g/dL e. Platelet count < 75 × 10^3/μL"}
  • {"criterion_text":"- 13. Has received treatment with teriflunomide within 3 months to randomization (unless elimination procedure was done)"}
  • {"criterion_text":"- 18. History of drug or alcohol abuse in the previous 12 months before screening in the opinion of the investigator"}
  • {"criterion_text":"- 28. History of Gilbert’s syndrome"}
  • {"criterion_text":"- 7. Prior use of other biologic immunomodulatory agents ≤ 6 months prior to randomization"}
  • {"criterion_text":"- 17. Has received live vaccine, live-attenuated vaccine, or live therapeutic infectious agent within the 4 weeks prior to randomization"}
  • {"criterion_text":"- 15. Has received lymphoid irradiation or stem cell transplantation"}
  • {"criterion_text":"- 8. Has received systemic corticosteroids or adrenocorticotropic hormone within 1 month (30 days) prior to screening MRI"}
  • {"criterion_text":"- 12. Has received azathioprine or methotrexate within 6 months prior to randomization"}
  • {"criterion_text":"- 9. Has received dimethyl fumarate within 1 month prior to randomization"}
  • {"criterion_text":"- 23. Abnormal liver function tests meeting any of the following criteria: a. Alanine aminotransferase > 2 × ULN b. Aspartate aminotransferase > 2 × ULN c. Total bilirubin > 1.5 × ULN"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Cumulative number of new GdE T1 hyperintense lesions over Week 8 and Week 12, as measured by brain MRI","definition_or_measurement_approach":"Measured by brain MRI; cumulative number of new gadolinium-enhancing T1 (GdE T1) hyperintense lesions assessed at Week 8 and Week 12."}

Secondary endpoints

  • {"endpoint_text":"- Cumulative number of new and/or enlarging T2 weighted hyperintense lesions detected over Week 8 and Week 12","definition_or_measurement_approach":"Detected and counted on brain MRI as new and/or enlarging T2-weighted hyperintense lesions at Week 8 and Week 12."}
  • {"endpoint_text":"- Number of new GdE T1 hyperintense lesions at Week 4, Week 8, and Week 12","definition_or_measurement_approach":"Count of new GdE T1 hyperintense lesions on brain MRI at Weeks 4, 8 and 12."}
  • {"endpoint_text":"- Change from baseline in volume of T2 lesions at Week 12","definition_or_measurement_approach":"MRI-based volumetric change from baseline in T2 lesion volume at Week 12."}
  • {"endpoint_text":"- Change from baseline in serum NfL at Week 12","definition_or_measurement_approach":"Change from baseline in serum neurofilament light chain (NfL) levels measured at Week 12."}
  • {"endpoint_text":"- Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs of special interest, (AESI), as defined by the Common Terminology of Criteria for Adverse Events (CTCAE) Version 5.0","definition_or_measurement_approach":"Safety assessed by incidence and classification of AEs, SAEs and AESI using CTCAE v5.0 definitions and reporting."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
52
Recruitment Window Months
31
Consent Approach
Informed consent must be signed by the participant (Inclusion criterion 1: 'Capable of giving signed informed consent'). Main ICFs and optional procedure ICFs (MRI, CSF, pregnancy/newborn, pharmacogenomics, future research) are provided in multiple country-specific languages (documents: Main-ICF and many language variants). Caregiver ICFs and specific ICF variants (e.g., Pregnancy ICF, Optional Procedures ICF) are available. Participants are adults (≥18) so no child assent procedures are described.

Methods

  • Study website (country-specific study website layouts provided) — channel: online study websites; target: patients with relapsing multiple sclerosis; country-specific website documents available (e.g. IT, ES, BE, CZ, AT, PL, HR, GRC, DK).
  • Printed materials / trifold study introduction brochures — channel: printed leaflets/trifold; target: potential participants and referring clinicians; country-specific trifold documents available.
  • GP / HCP letters (e.g. Italy GP letter) — channel: direct communication to healthcare professionals to support patient referral.
  • Recruitment arrangements and country recruitment brochures (K1/K2 documents) — channel: country-specific recruitment packs; target: patients and local clinics.
  • Study branding and printed materials managed by third parties (Jumo Health USA Inc.) — channel: branded recruitment materials at site level.
  • Patient travel assistance and reimbursement support (Clincierge / Gray Consulting involvement) — channel: patient-facing travel assistance and payment portals to facilitate attendance.
  • Site-based recruitment via participating hospitals/neurology clinics (site lists provided for each country).

Geography

Total Number Of Sites
26
Total Number Of Participants
60

Finland

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
01-10-2024
Processing Time Days
32
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Clinical Research Services Turku CRST Oy
Contact Person Name
Laura Airas
Contact Person Email
Laura.airas@utu.fi

Denmark

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
20-05-2025
Processing Time Days
242
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Aalborg University Hospital
Department Name
Neorologisk afdeling
Contact Person Name
Jakob Schäfer
Contact Person Email
jasch@rn.dk

Italy

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
21-05-2025
Processing Time Days
328
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.S.D. di Neurologia
Contact Person Name
Cinzia Cordioli
Contact Person Email
cinzia.cordioli@gmail.com
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOSD Sclerosi Multipla
Contact Person Name
Girolama Alessandra Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
Careggi University Hospital
Department Name
SOD Complessa Riabilitazione Neurologica
Contact Person Name
Maria Pia Amato
Contact Person Email
mariapia.amato@unifi.it
Site Name
Fondazione Istituto G. Giglio Di Cafalu
Department Name
Unità Operativa di Neurologia
Contact Person Name
Luigi Grimaldi
Contact Person Email
luigi.grimaldi@hsrgiglio.it
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
Unità Operativa Complessa di Neurologia
Contact Person Name
Diego Centonze
Contact Person Email
centonze@uniroma2.it

Spain

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
23-05-2025
Processing Time Days
268
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Neurology
Contact Person Name
Celia Oreja-Guevara
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Neurology
Contact Person Name
José Eustasio Meca Lallana
Contact Person Email
josee.meca@carm.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Neurology
Contact Person Name
Jose Manuel Garcia Dominguez
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Contact Person Name
Francisco Carlos Perez Miralles
Contact Person Email
miralles_neuro@hotmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Contact Person Name
Ana Maria Alonso Torres
Contact Person Email
a.alonso.eecc@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurology
Contact Person Name
Sara Eichau Madueño
Contact Person Email
saraeichau@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
19-05-2025
Processing Time Days
263
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
Neurology
Contact Person Name
Maarten Buyle
Contact Person Email
Maarten.buyle@azdelta.be
Site Name
Noorderhart
Department Name
Neurology
Contact Person Name
Veronica Popescu

Austria

Earliest CTIS Part Ii Submission Date
03-09-2024
Latest Decision Or Authorization Date
06-06-2025
Processing Time Days
276
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Neuro-logisch
Contact Person Name
Fritz Leutmezer
Contact Person Email
office@neuro-logisch.at

Poland

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
296
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Contact Person Name
Robert Bonek
Contact Person Email
r.bonek@ncbydgoszcz.pl
Site Name
Zanamed Medical Clinic Sp. z o.o.
Contact Person Name
Małgorzata Kulka
Contact Person Email
malgorzata.kulka@zanamed.pl
Site Name
Wielospecjalistyczne Centrum Medyczne "IBISMED" S.C.
Contact Person Name
Monika Adamczyk-Sowa
Contact Person Email
m.adamczyk.sowa@gmail.com
Site Name
Ma-Lek Clinical Sp. z o.o.
Contact Person Name
Maciej Maciejowski
Contact Person Email
m.m@ctsm.pl

Croatia

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
19-06-2025
Processing Time Days
292
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
University Hospital Centre Zagreb
Department Name
Neurology
Contact Person Name
Mario Habek
Contact Person Email
mhabek@mef.hr

Greece

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
372
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
General University Hospital Of Larissa
Department Name
Neurology Department
Contact Person Name
Efthimios Dardiotis
Contact Person Email
ebsdar@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Department of Neurology Clinic of the National and Kapodistrian University of Athens
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr

Czechia

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
19-08-2025
Processing Time Days
354
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurologická klinika
Contact Person Name
Eva Kubala HAVRDOVÁ
Contact Person Email
ehavr@lf1.cuni.cz
Site Name
Nemocnice Jihlava prispevkova organizace
Department Name
Neurologické oddělení
Contact Person Name
Radek Ampapa
Contact Person Email
ampapa@centrum.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Neurologická klinika
Contact Person Name
Michal Dufek
Contact Person Email
michal.dufek@fnusa.cz

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD Global Ltd.
Responsibilities
Project management duties or monitoring/regulatory
Name
PPD Development LP
Responsibilities
Medical Monitoring; operational and clinical support (multiple sponsor duties listed)

Third parties

  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Project management duties or monitoring/regulatory","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Inato","duties_or_roles":"Feasibility","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Gray Consulting Inc.","duties_or_roles":"Patient travel and Reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"MRI Scan Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Everest Clinical Research Corporation","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Study Branding and printing materials","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Medical Monitoring; multiple operational and clinical support functions (codes present in sponsor duties)","organisation_type":"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 product entry present (euMpNumber PRD9993985, prodAuthStatus=1); MIA/IMP numbers: DE_BB_01_MIA_2021_0008 and IMP11566/00001
Orphan Designation
Yes
Starting Dose
250 mg
Dose Levels
250 mg
Frequency
Once weekly (QW)
Maximum Dose
Max daily 250 mg; max total amount 6000 mg
Investigational Product Name
Placebo sterile solution for SC injection
Modality
Other
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Frequency
Once weekly (QW)

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