A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)
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)
4 other identifiers
interventional
113
21 countries
73
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2022
Longer than P75 for phase_3
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
September 30, 2021
CompletedStudy Start
First participant enrolled
February 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
April 30, 2026
April 1, 2026
5.3 years
September 21, 2021
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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; 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.
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.
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
Secondary Outcomes (5)
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
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)
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
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
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
Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
Study Arms (2)
Rozanolixizumab Arm
EXPERIMENTALParticipants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.
Placebo Arm
PLACEBO COMPARATORParticipants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.
Interventions
* Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive pre-specified doses of rozanolixizumab.
* Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive placebo.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Mog001 50297
Scottsdale, Arizona, 85259-5452, United States
Mog001 50450
Palo Alto, California, 94304, United States
Mog001 50101
Aurora, Colorado, 80045, United States
Mog001 50553
Washington D.C., District of Columbia, 20057, United States
Mog001 50308
Tampa, Florida, 33612, United States
Mog001 50472
Peoria, Illinois, 61637, United States
Mog001 50074
Kansas City, Kansas, 66160, United States
Mog001 50552
Baltimore, Maryland, 21287, United States
Mog001 50243
Boston, Massachusetts, 02114-3117, United States
Mog001 50104
Rochester, Minnesota, 55905, United States
Mog001 50571
Cleveland, Ohio, 44106, United States
Mog001 50304
Dallas, Texas, 75390-9036, United States
Mog001 50568
San Antonio, Texas, 78229, United States
Mog001 50473
Salt Lake City, Utah, 84108, United States
Mog001 30022
Melbourne, Australia
Mog001 40123
Anderlecht, Belgium
Mog001 40756
Bruxelles/brussel, Belgium
Mog001 40122
Edegem, Belgium
Mog001 40185
Ghent, Belgium
Mog001 60033
Porto Alegre, Brazil
Mog001 40195
Hradec Králové, Czechia
Mog001 40124
Prague, Czechia
Mog001 40721
Teplice, Czechia
Mog001 40657
Bron, France
Mog001 40755
Montpellier, France
Mog001 40170
Strasbourg, France
Mog001 40659
Berlin, Germany
Mog001 40386
Cologne, Germany
Mog001 40140
Göttingen, Germany
Mog001 40177
Münster, Germany
Mog001 40577
Ulm, Germany
Mog001 40850
Athens, Greece
Mog001 40851
Thessaloniki, Greece
Mog001 40146
Pavia, Italy
Mog001 40629
Roma, Italy
Mog001 40646
Verona, Italy
Mog001 20225
Bunkyō City, Japan
Mog001 20068
Chiba, Japan
Mog001 20307
Isehara, Japan
Mog001 20049
Kitakyushu, Japan
Mog001 20143
Kodaira, Japan
Mog001 20223
Kōriyama, Japan
Mog001 20224
Sendai, Japan
Mog001 20227
Sendai, Japan
Mog001 20070
Shinjuku-ku, Japan
Mog001 20032
Suita, Japan
Mog001 50486
Culiacán, Mexico
Mog001 50485
Mexico City, Mexico
Mog001 40840
Bydgoszcz, Poland
Mog001 40485
Coimbra, Portugal
Mog001 40669
Porto, Portugal
Mog001 20226
Goyang-si, South Korea
Mog001 40267
Barcelona, Spain
Mog001 40100
Madrid, Spain
Mog001 40161
Madrid, Spain
Mog001 40341
Málaga, Spain
Mog001 40350
Murcia, Spain
Mog001 40049
Seville, Spain
Mog001 40663
Huddinge, Sweden
Mog001 40723
Basel, Switzerland
Mog001 40337
Bern, Switzerland
Mog001 40630
Zurich, Switzerland
Mog001 20080
Taichung, Taiwan
Mog001 20094
Tainan, Taiwan
Mog001 40849
Bursa, Turkey (Türkiye)
Mog001 40550
Istanbul, Turkey (Türkiye)
Mog001 40726
Izmir, Turkey (Türkiye)
Mog001 40648
Samsun, Turkey (Türkiye)
Mog001 40725
Sancaktepe, Turkey (Türkiye)
Mog001 20319
Kyiv, Ukraine
Mog001 20228
Ternopil, Ukraine
Mog001 40661
Liverpool, United Kingdom
Mog001 40163
Oxford, United Kingdom
Related Publications (1)
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.
PMID: 35674086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- MOG001 consists of a Double-Blind (Part A) and an Open-Label Extension Study Period (Part B).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2021
First Posted
September 30, 2021
Study Start
February 2, 2022
Primary Completion (Estimated)
May 6, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.