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

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)
• Intervention / Treatment: Drug: Rozanolixizumab; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: UCB Cares; Phone Number: 1-844-599-2273 (USA); Email: ucbcares@ucb.com
• Study Contact Backup: Name: UCB Cares; Phone Number: 001 844 599 2273; Email: UCBCares@ucb.com

Study Locations

• Australia
  • Southport, Australia
    • Recruiting
    • Mog001 30026
• Belgium
  • Gent, Belgium
    • Recruiting
    • Mog001 40185
• Brazil
  • Porto Alegre, Brazil
    • Recruiting
    • Mog001 60033
• Czechia
  • Hradec Kralove, Czechia
    • Recruiting
    • Mog001 40195
  • Prague 2, Czechia
    • Recruiting
    • Mog001 40124
  • Teplice, Czechia
    • Recruiting
    • Mog001 40721
• France
  • Bron Cedex, France
    • Recruiting
    • Mog001 40657
  • Caen, France
    • Recruiting
    • Mog001 40422
  • Marseille, France
    • Recruiting
    • Mog001 40130
  • Strasbourg, France
    • Recruiting
    • Mog001 40170
• Germany
  • Berlin, Germany
    • Recruiting
    • Mog001 40659
  • Göttingen, Germany
    • Recruiting
    • Mog001 40140
  • ULM, Germany
    • Recruiting
    • Mog001 40577
• Italy
  • Pavia, Italy
    • Recruiting
    • Mog001 40146
  • Roma, Italy
    • Recruiting
    • Mog001 40629
  • Verona, Italy
    • Recruiting
    • Mog001 40646
• Japan
  • Bunkyo-ku, Japan
    • Recruiting
    • Mog001 20225
  • Chiba-shi, Japan
    • Recruiting
    • Mog001 20068
  • Isehara, Japan
    • Recruiting
    • Mog001 20307
  • Kodaira, Japan
    • Recruiting
    • Mog001 20143
  • Koriyama, Japan
    • Recruiting
    • Mog001 20223
  • Sendai, Japan
    • Recruiting
    • Mog001 20224
  • Sendai, Japan
    • Recruiting
    • Mog001 20227
  • Shinjuku-ku, Japan
    • Recruiting
    • Mog001 20070
  • Suita, Japan
    • Recruiting
    • Mog001 20032
• Korea, Republic of
  • Goyang-si, Korea, Republic of
    • Recruiting
    • Mog001 20226
  • Seoul, Korea, Republic of
    • Recruiting
    • Mog001 20104
• Mexico
  • Ciudad de Mexico, Mexico
    • Recruiting
    • Mog001 50485
  • Culiacán, Mexico
    • Recruiting
    • Mog001 50486
• Portugal
  • Porto, Portugal
    • Recruiting
    • Mog001 40669
• Spain
  • Barcelona, Spain
    • Recruiting
    • Mog001 40267
  • Madrid, Spain
    • Recruiting
    • Mog001 40100
  • Madrid, Spain
    • Recruiting
    • Mog001 40161
• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Mog001 40660
  • Huddinge, Sweden
    • Recruiting
    • Mog001 40663
• Switzerland
  • Basel, Switzerland
    • Recruiting
    • Mog001 40723
  • Bern, Switzerland
    • Recruiting
    • Mog001 40337
• Taiwan
  • Changhua County,changhua CITY, Taiwan
    • Recruiting
    • Mog001 20096
  • Kaohsuing CITY, Taiwan
    • Recruiting
    • Mog001 20303
  • Taichung City, Taiwan
    • Recruiting
    • Mog001 20080
  • Tainan City, Taiwan
    • Recruiting
    • Mog001 20094
  • Taipei City, Taiwan
    • Recruiting
    • Mog001 20304
  • Taoyuan City, Taiwan
    • Recruiting
    • Mog001 20082
• Turkey
  • Izmir, Turkey
    • Recruiting
    • Mog001 40726
  • Samsun, Turkey
    • Recruiting
    • Mog001 40648
  • Sancaktepe, Turkey
    • Recruiting
    • Mog001 40725
  • İ̇stanbul, Turkey
    • Recruiting
    • Mog001 40550
• Ukraine
  • Ternopil, Ukraine
    • Recruiting
    • Mog001 20228
• United Kingdom
  • Liverpool, United Kingdom
    • Recruiting
    • Mog001 40661
  • Oxford, United Kingdom
    • Recruiting
    • Mog001 40163
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259-5452
      • Recruiting
      • Mog001 50297
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Mog001 50450
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Mog001 50101
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Recruiting
      • Mog001 50553
  • Florida
    • Jacksonville, Florida, United States, 32224-1865
      • Recruiting
      • Mog001 50342
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Recruiting
      • Mog001 50472
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • Mog001 50074
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Mog001 50552
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-3117
      • Recruiting
      • Mog001 50243
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mog001 50104
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Mog001 50571
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • Mog001 50473

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rozanolixizumab Arm; Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.	Drug: Rozanolixizumab; Pharmaceutical form: Solution for infusion; Route of administration: subcutaneous infusion Participants will receive pre-specified doses of rozanolixizumab.; Other Names: UCB7665
Placebo Comparator: Placebo Arm; Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.	Other: Placebo; Pharmaceutical form: Solution for infusion; Route of administration: subcutaneous infusion Participants will receive placebo.; Other Names: PBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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. During Part B.	OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
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	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. During Part A.	From Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 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. During Part A.	Baseline (Week 1), EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
For Part A: Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period	The total number of MOG-AD related hospitalizations from Baseline through EDB/EWD Visit. During Part A.	Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB 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. During Part A.	Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Publications and helpful links

General Publications

• Mader S, Kumpfel T, Meinl E. Pathomechanisms in demyelination and astrocytopathy: autoantibodies to AQP4, MOG, GFAP, GRP78 and beyond. Curr Opin Neurol. 2022 Jun 1;35(3):427-435. doi: 10.1097/WCO.0000000000001052.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): October 5, 2026

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: MOGAD; MOG; Rozanolixizumab; Myelin oligodendrocyte glycoprotein; Myelin oligodendrocyte glycoprotein antibody-associated disease
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Rozanolixizumab
• Other Study ID Numbers: MOG001; 2021-000352-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• IPD Sharing Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes