Clinical trial NCT06564311: A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing Multiple Sclerosis
RMS
MS
Multiple Sclerosis
Lead sponsor: Zenas BioPharma (USA), LLC
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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), a 52 week open label extension 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, a 12-week Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. After Part B, patients will enter Part C, a 52-week Open-Label Extension (OLE), after which they will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part C (i.e. Week 88). 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 92 weeks (Screening Period = 4 weeks, Parts A, B and C = 76 weeks, Follow-up Period = 12 weeks).

Eligibility 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

Primary outcomes:
measure: Cumulative number of new GdE T1 hyperintense lesions
timeFrame: Week 8 and Week 12
Secondary outcomes:
measure: Number of T2 Lesions
timeFrame: Week 8 and Week 12
measure: Number of GdE T1 lesions
timeFrame: Week 4, Week 8, and Week 12
measure: Volume of T2 lesions
timeFrame: Week 12
measure: Serum NfL
timeFrame: Week 12
measure: Incidence of Adverse Events, injection site reactions and hypersensitivity reactions
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology
state: Alabama
city: Phoenix
country: United States
facility: Center for Neurology and Spine
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center
state: Arizona
city: West Hollywood
country: United States
facility: Regina Berkovich MD PhD, Inc
state: California
city: Naples
country: United States
facility: Aqualine Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Plymouth
country: United States
facility: Infusion Associates Plymouth
state: Minnesota
city: Saint Louis
country: United States
facility: MS Center for Innovations in Care
state: Missouri
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Columbus
country: United States
facility: Boster Center for MS
state: Ohio
city: Plano
country: United States
facility: North Texas Institute of Neurology and Headache
state: Texas
city: Greenfield
country: United States
facility: Center for Neurological Disorders
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Wien
country: Austria
facility: Neuro-logisch Wien
city: Pelt
country: Belgium
facility: Rehabilitation & MS Center, Noorderhart Hospital
city: Roeselare
country: Belgium
facility: AZ Delta-Deltalaan 1
city: Beijing
country: China
facility: Tiantan Hospital, Capital Medical University
city: Suzhou
country: China
facility: The First Affiliation Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical Center of HUST
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uyaur Autonomous Region
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Praha
country: Czechia
facility: General University Hospital Praha
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Chaïdári
country: Greece
facility: Attikon University General Hospital
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Cefalù
country: Italy
facility: Fondazione Isituto G. Giglio di Cefalu
city: Florence
country: Italy
facility: University of Florence
city: Pozzilli
country: Italy
facility: Istituto Neurologico Mediterraneo Neuromed
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
city: Bydgoszcz
country: Poland
facility: Neurocentrum Bydgoszcz sp.z o.o.
city: Katowice
country: Poland
facility: M.A. LEK A.M. Maciejowsy Spolka Cywilna
city: Lublin
country: Poland
facility: Zanamed Medical Clinic Sp z o.o.
city: Zabrze
country: Poland
facility: Wielospecjalistyczne Centrum Medyczne Ibismed
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital General
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Valencia
country: Spain
facility: Hospipal La Fe Valencia
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
References: