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NCT Number: NCT05063162

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mog001 30022, Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rozanolixizumab

Drug
  • Pharmaceutical form: Solution for infusion
  • Route of administration: subcutaneous infusion

Participants will receive pre-specified doses of rozanolixizumab.

Other names: UCB7665

Placebo

Other
  • Pharmaceutical form: Solution for infusion
  • Route of administration: subcutaneous infusion

Participants will receive placebo.

Other names: PBO

Primary outcomes

  1. For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) 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)

    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

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

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

    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.

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

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

    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.

Secondary outcomes

  1. 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

    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)

    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.

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

    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)

    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.

  3. For Part A: Number of MOGAD related inpatient hospitalizations 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)

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

  4. 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)

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

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)

Acronym: cosMOG

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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