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

NCT06564311 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ZB012-02-002
• Study Type: interventional
• Target: 93
• Locations: 12 countries
• Sites: 47

Brief Summary

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

Conditions

Relapsing Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis; RMS; MS; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Cumulative number of new GdE T1 hyperintense lesions

  Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI

  Week 8 and Week 12

Secondary Outcomes (5)

• Number of T2 Lesions

  Week 8 and Week 12

• Number of GdE T1 lesions

  Week 4, Week 8, and Week 12

• Volume of T2 lesions

  Week 12

• Serum NfL

  Week 12

• Incidence of Adverse Events, injection site reactions and hypersensitivity reactions

  24 weeks

Study Arms (2)

Obexelimab

EXPERIMENTAL

Obexelimab will be administered as a subcutaneous injection for 76 weeks

Drug: Obexelimab

Placebo

PLACEBO COMPARATOR

Placebo will be administered as a subcutaneous injection for 12 weeks

Drug: Placebo

Interventions

Obexelimab DRUG

Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRIIb, resulting in down regulation of B cell activity

Obexelimab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
• An EDSS of ≤ 5.5 at the Screening Visit
• Must have documentation of:
• at least 1 relapse within the previous year OR
• ≥ 2 relapses within the past 2 years OR
• ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
• Not of childbearing potential or willing to follow contraceptive guidance

You may not qualify if:

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

Sponsors & Collaborators

• Zenas BioPharma (USA), LLC: lead

Study Sites (47)

North Central Neurology

Cullman, Alabama, 35058, United States

Location

Center for Neurology and Spine

Phoenix, Arizona, 85032, United States

Location

Perseverance Research Center

Scottsdale, Arizona, 85253, United States

Location

Regina Berkovich MD PhD, Inc

West Hollywood, California, 90048, United States

Location

Aqualine Clinical Research

Naples, Florida, 35105, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Infusion Associates Plymouth

Plymouth, Minnesota, 55446, United States

Location

MS Center for Innovations in Care

St Louis, Missouri, 63131, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Boster Center for MS

Columbus, Ohio, 43235, United States

Location

North Texas Institute of Neurology and Headache

Plano, Texas, 75024, United States

Location

Center for Neurological Disorders

Greenfield, Wisconsin, 53228, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Neuro-logisch Wien

Vienna, Austria

Location

Rehabilitation & MS Center, Noorderhart Hospital

Overpelt, Belgium

Location

AZ Delta-Deltalaan 1

Roeselare, Belgium

Location

Tiantan Hospital, Capital Medical University

Beijing, China

Location

The First Affiliation Hospital of Soochow University

Suzhou, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

People's Hospital of Xinjiang Uyaur Autonomous Region

Ürümqi, China

Location

Tongji Hospital, Tongji Medical Center of HUST

Wuhan, China

Location

Klinicki bolnicki centar Zagreb

Zagreb, Croatia

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Location

Nemocnice Jihlava

Jihlava, Czechia

Location

General University Hospital Praha

Prague, Czechia

Location

Aalborg Universitetshospital

Aalborg, Denmark

Location

Attikon University General Hospital

Chaïdári, Greece

Location

University General Hospital of Larissa

Larissa, Greece

Location

Fondazione Isituto G. Giglio di Cefalu

Cefalù, Italy

Location

University of Florence

Florence, Italy

Location

Istituto Neurologico Mediterraneo Neuromed

Pozzilli, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Roma, Italy

Location

Neurocentrum Bydgoszcz sp.z o.o.

Bydgoszcz, Poland

Location

M.A. LEK A.M. Maciejowsy Spolka Cywilna

Katowice, Poland

Location

Zanamed Medical Clinic Sp z o.o.

Lublin, Poland

Location

Wielospecjalistyczne Centrum Medyczne Ibismed

Zabrze, Poland

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Location

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, Spain

Location

Hospital Universitario Virgen de La Arrixaca

Murcia, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

Hospipal La Fe Valencia

Valencia, Spain

Location

Leicester General Hospital

Leicester, United Kingdom

Location

Barts Health NHS Trust

London, United Kingdom

Location

Morriston Hospital

Swansea, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, Care Providers, Investigator, Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 2, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of obexelimab in patients with RMS. The study consists of a Screening Period (Day 28 to Day -1), followed by a 24-week Treatment Period (Part A or RCP consists of 12 doses of obexelimab or placebo; Part B or OLP consists of 12 doses of open-label obexelimab), a 52-week OLE and an expected 12-week Follow-up Period.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: August 26, 2024
• Primary Completion: August 28, 2025
• Study Completion: February 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-06

Locations

CN (5); US (14); CZ (3); DK (1); IT (4); ES (7); PL (4); BE (2); GB (3); GR (2); CR (1); AU (1)