A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)

Phase 2

Recruiting

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: Obexelimab; Drug: Placebo

• Registration Number: NCT06564311
• Lead Sponsor: Zenas BioPharma (USA), LLC

Brief Summary

This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis

Detailed Description

The study consists of a Screening Period (Day -28 to Day -1), a 24-week treatment period (Part A and Part B), and an expected 12-week Follow-up Period. Patients with Relapsing Multiple Sclerosis will be randomized in 2:1 ratio to obexelimab or placebo. Randomization will be stratified by Gd lesion status at screening (≥ 1 vs 0).

Part A is the 12-week Randomized Placebo-Controlled Period (RCP), during which obexelimab or placebo will be administered as weekly subcutaneous (SC) injections. Following Part A, all patients will enter the Part B, Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. Patients will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part B (i.e. Week 36). If at this time, B cells have not returned to baseline or above the lower limit of normal (LLN), patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN (at minimum). The maximum expected duration of the study is 40 weeks (Screening Period = 4 weeks, Parts A and B = 24 weeks, Follow-up Period = 12 weeks).

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Study Start: 2024-08-26
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obexelimab	Obexelimab	Obexelimab will be administered as a subcutaneous injection for 24 weeks
Placebo	Placebo	Placebo will be administered as a subcutaneous injection for 12 weeks

Primary Outcome Measures

Name	Time	Method
Cumulative number of new GdE T1 hyperintense lesions	Week 8 and Week 12	Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI

Secondary Outcome Measures

Name	Time	Method
Volume of T2 lesions	Week 12	change from baseline in volume of T2 lesions
Number of T2 Lesions	Week 8 and Week 12	cumulative number of new and/or enlarging T2 weighted hyperintense lesions
Number of GdE T1 lesions	Week 4, Week 8, and Week 12	number of new GdE T1 hyperintense lesions
Serum NfL	Week 12	serum NfL
Incidence of Adverse Events, injection site reactions and hypersensitivity reactions	24 weeks	Incidence of Adverse Events, injection site reactions and hypersensitivity reactions, serious adverse events, and adverse events of special interest, as defined by the CTCAE v5.0

Trial Locations

Locations (30)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States

Fakultni nemocnice u sv. Anny v Brne; 🇨🇿 Brno, Czechia

Regina Berkovich MD PhD, Inc; 🇺🇸 West Hollywood, California, United States

Aqualine Clinical Research; 🇺🇸 Naples, Florida, United States

Sharlin Health Neuroscience Research; 🇺🇸 Ozark, Missouri, United States

MS Center for Innovations in Care; 🇺🇸 Saint Louis, Missouri, United States

Holy Name Medical Center; 🇺🇸 Teaneck, New Jersey, United States

Boster Center for MS; 🇺🇸 Columbus, Ohio, United States

North Texas Institute of Neurology and Headache; 🇺🇸 Plano, Texas, United States

MS Center of Greater Washington; 🇺🇸 Vienna, Virginia, United States

Center for Neurological Disorders; 🇺🇸 Greenfield, Wisconsin, United States

AZ Delta-Deltalaan 1; 🇧🇪 Roeselare, Belgium

Klinicki bolnicki centar Zagreb; 🇭🇷 Zagreb, Croatia

Nemocnice Jihlava; 🇨🇿 Jihlava, Czechia

Aalborg Universitetshospital; 🇩🇰 Aalborg, Denmark

Attikon University General Hospital; 🇬🇷 Chaïdári, Greece

University General Hospital of Larissa; 🇬🇷 Larissa, Greece

Fondazione Isituto G. Giglio di Cefalu; 🇮🇹 Cefalù, Italy

University of Florence; 🇮🇹 Florence, Italy

Istituto Neurologico Mediterraneo Neuromed; 🇮🇹 Pozzilli, Italy

Fondazione PTV Policlinico Tor Vergata; 🇮🇹 Roma, Italy

Neurocentrum Bydgoszcz sp.z o.o.; 🇵🇱 Bydgoszcz, Poland

M.A. LEK A.M. Maciejowsy Spolka Cywilna; 🇵🇱 Katowice, Poland

Zanamed Medical Clinic Sp z o.o.; 🇵🇱 Lublin, Poland

Wielospecjalistyczne Centrum Medyczne Ibismed; 🇵🇱 Zabrze, Poland

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital General; 🇪🇸 Málaga, Spain

Hospital Regional Universitario de Malaga; 🇪🇸 Málaga, Spain

Hospipal La Fe Valencia; 🇪🇸 Valencia, Spain