Clinical trial

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)

Name

MOG001

Description

The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD).

Trial arms

Trial start

2022-02-02

Estimated PCD

2026-08-10

Trial end

2026-10-05

Status

Recruiting

Phase

Early phase I

Treatment

Rozanolixizumab

* Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive pre-specified doses of rozanolixizumab.

Arms:

Rozanolixizumab Arm

Other names:

UCB7665

Placebo

* Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive placebo.

Arms:

Placebo Arm

Other names:

PBO

Size

104

Primary endpoint

For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period

Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)

For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period

OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)

For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period

OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)

Eligibility criteria

Inclusion Criteria: * Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent * Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD * Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization * Participant must be clinically stable at the time of the Screening Visit and during the Screening Period Exclusion Criteria: * Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant * Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP) * Participant has a current or medical history of primary immunodeficiency * Participant tests positive for aquaporin-4 antibodies at Screening * Participant has a serum total IgG level ≤ 5.5g/L

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'MOG001 consists of a Double-Blind (Part A) and an Open-Label Extension Study Period (Part B).', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}

Updated at

2024-04-26

1 organization

1 product

1 indication

Product

Rozanolixizumab

Indication

MOG-AD

Organization

UCB Biopharma