A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)

Phase 3Active Not RecruitingNCT05063162

UCB Biopharma SRL113 enrolled

Overview

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 (MOGAD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

113

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Interventions

RozanolixizumabDRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent * Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD * Participant has history of relapsing MOGAD 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

Locations (55)

Outcomes

Primary Outcomes

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

The TTFR (days) will be defined as the interval between the date of randomization and the first date of the objective relapse. During the Double Blind (DB) Treatment Period (Part A); EDB/EWD = End of Double-Blind/Early Withdrawal Visit

Time frame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

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

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Open-Label Extension (OLE) Treatment Period (Part B); EOS/EWD = End of Study/Early Withdrawal Visit.

Time frame: 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

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.

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

Secondary Outcomes

For Part A: Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit

Data from ClinicalTrials.gov

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Mog001 50297

Scottsdale, Arizona, United States

Mog001 50450

Palo Alto, California, United States

Mog001 50101

Aurora, Colorado, United States

Mog001 50553

Washington D.C., District of Columbia, United States

Mog001 50308

Tampa, Florida, United States

Mog001 50472

Peoria, Illinois, United States

Mog001 50552

Baltimore, Maryland, United States

Mog001 50243

Boston, Massachusetts, United States

Mog001 50104

Rochester, Minnesota, United States

Mog001 50568

San Antonio, Texas, United States

...and 45 more locations

Visual acuity is a measurement of the capacity for visual discrimination of fine details. Visual acuity tests are used to determine the smallest characters that can be read on a standardized chart. The Landolt C Broken Ring Chart uses standardized incomplete rings or "C", which are positioned in any direction in the chart (up, down, left, right, and 45 degree positions in between). The participant has to be able to indicate where the break of the "C" is located, by describing the position or by giving gesture.

Time frame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)

The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments with half steps from 1.0 to 9.5. The higher the value the higher is the level of impairment and disability.

Time frame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

For Part A: Number of MOGAD related inpatient hospitalizations during the DB Treatment Period

The total number of MOGAD related hospitalizations from Baseline through EDB/EWD Visit.

Time frame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period

Time frame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period

An ARR will be calculated for each participant prior to randomization into the Double-Blind Treatment Period (based on available historical data), and 2 ARRs after randomization to study treatment: first for relapses occurring during the Double-Blind Treatment Period and the second for relapses occurring during the OLE Treatment Period. The relapse episodes for each participant will be recorded throughout the entire study.

Time frame: Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)