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Examining obexelimab for treating relapsing multiple sclerosis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis

Phase 2 Interventional Zenas BioPharma (USA), LLC · NCT06564311

This study is testing a new drug called obexelimab to see if it can help people with relapsing multiple sclerosis feel better and stay safe during treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment93 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorZenas BioPharma (USA), LLC Industry-sponsored
Drugs / interventionsobexelimab
Locations49 sites (Cullman, Alabama and 48 other locations)
Trial IDNCT06564311 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of obexelimab in patients diagnosed with relapsing multiple sclerosis. Participants will undergo a screening period followed by a 24-week treatment phase, which includes a randomized placebo-controlled period and an open-label extension. Patients will receive weekly subcutaneous injections of either obexelimab or a placebo, with randomization based on their Gd lesion status. The study also includes a follow-up period to monitor safety and B cell recovery after treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with relapsing multiple sclerosis who have experienced recent relapses or have active Gd-enhancing lesions.

Not a fit: Patients with primary progressive MS or those who have not experienced relapses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsing multiple sclerosis, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promise with similar monoclonal antibody approaches in treating multiple sclerosis, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
2. An EDSS of ≤ 5.5 at the Screening Visit
3. Must have documentation of:

   1. . at least 1 relapse within the previous year OR
   2. . ≥ 2 relapses within the past 2 years OR
   3. . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
4. Not of childbearing potential or willing to follow contraceptive guidance

Exclusion Criteria:

1. Primary progressive MS or secondary progressive MS without relapses
2. Meet criteria for neuromyelitis optica spectrum disorder
3. Relapse in the 30 days prior to randomization
4. ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
5. Has \> 20 Gd+ lesions on brain MRI at screening

Where this trial is running

Cullman, Alabama and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing Multiple SclerosisRMSMSMultiple Sclerosis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.