NCT06564311Active, not recruitingPhase 2
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 93 (estimated)
- First submitted
- 19 Aug 2024
- Start date
- 26 Aug 2024
- Primary completion date
- 28 Aug 2025
- Lead sponsor
- Zenas BioPharma (USA), LLC
- Diseases
- Multiple sclerosis
- NCT number
- NCT06564311
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 93
- From 26 Aug 2024 to the primary completion date, 28 Aug 2025
- 47 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Relapse in the 30 days prior to randomization
Other illness
- Meet criteria for neuromyelitis optica spectrum disorder
Age
- ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
Other
- Primary progressive MS or secondary progressive MS without relapses
- Has \> 20 Gd+ lesions on brain MRI at screening
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neuro-logisch Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Rehabilitation & MS Center, Noorderhart Hospital Coordinator of this site? Confirm its status | Overpelt | Belgium | Unknown status |
| AZ Delta-Deltalaan 1 Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| Tiantan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliation Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| People's Hospital of Xinjiang Uyaur Autonomous Region Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Tongji Hospital, Tongji Medical Center of HUST Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Fakultni nemocnice u sv. Anny v Brne Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Nemocnice Jihlava Coordinator of this site? Confirm its status | Jihlava | Czechia | Unknown status |
| General University Hospital Praha Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Aalborg Universitetshospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Regional Universitario de Malaga - Hospital General Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospipal La Fe Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Leicester General Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Morriston Hospital Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
| Attikon University General Hospital Coordinator of this site? Confirm its status | Chaïdári | Greece | Unknown status |
| University General Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Unknown status |
| Klinicki Bolnicki Centar Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Fondazione Isituto G. Giglio di Cefalu Coordinator of this site? Confirm its status | Cefalù | Italy | Unknown status |
| University of Florence Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Istituto Neurologico Mediterraneo Neuromed Coordinator of this site? Confirm its status | Pozzilli | Italy | Unknown status |
| Fondazione PTV - POLICLINICO TOR VERGATA Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Neurocentrum Bydgoszcz sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| M.A. LEK A.M. Maciejowsy Spolka Cywilna Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Zanamed Medical Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Wielospecjalistyczne Centrum Medyczne Ibismed Coordinator of this site? Confirm its status | Zabrze | Poland | Unknown status |
| Boster Center for MS Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| North Central Neurology Coordinator of this site? Confirm its status | Cullman | United States | Unknown status |
| Center for Neurological Disorders Coordinator of this site? Confirm its status | Greenfield | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Aqualine Clinical Research Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| Center for Neurology and Spine Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| North Texas Institute of Neurology and Headache Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Infusion Associates Plymouth Coordinator of this site? Confirm its status | Plymouth | United States | Unknown status |
| Perseverance Research Center Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| MS Center for Innovations in Care Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Holy Name Medical Center Coordinator of this site? Confirm its status | Teaneck | United States | Unknown status |
| Regina Berkovich MD PhD Inc Coordinator of this site? Confirm its status | West Hollywood | United States | Unknown status |
| University of Massachusetts Medical School Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.