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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05063162
Registration number
NCT05063162
Ethics application status
Date submitted
21/09/2021
Date registered
30/09/2021
Date last updated
21/06/2024
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)
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Scientific 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)
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Secondary ID [1]
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2021-000352-19
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Secondary ID [2]
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MOG001
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Universal Trial Number (UTN)
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Trial acronym
cosMOG
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rozanolixizumab
Other interventions - Placebo
Experimental: Rozanolixizumab Arm - Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.
Placebo comparator: Placebo Arm - Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.
Treatment: Drugs: Rozanolixizumab
* Pharmaceutical form: Solution for infusion
* Route of administration: subcutaneous infusion
Participants will receive pre-specified doses of rozanolixizumab.
Other interventions: Placebo
* Pharmaceutical form: Solution for infusion
* Route of administration: subcutaneous infusion
Participants will receive placebo.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period
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Assessment method [1]
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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
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Timepoint [1]
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Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
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Primary outcome [2]
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For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period
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Assessment method [2]
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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.
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Timepoint [2]
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OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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Primary outcome [3]
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For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period
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Assessment method [3]
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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.
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Timepoint [3]
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OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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Secondary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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From Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
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Secondary outcome [2]
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For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (Week 1), EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
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Secondary outcome [3]
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For Part A: Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period
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Assessment method [3]
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The total number of MOG-AD related hospitalizations from Baseline through EDB/EWD Visit.
During Part A.
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Timepoint [3]
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Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
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Secondary outcome [4]
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For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
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Secondary outcome [5]
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For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
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Eligibility
Key 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
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Minimum age
18
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Maximum age
89
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/10/2026
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Actual
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Sample size
Target
104
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Mog001 30022 - Melbourne
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Recruitment hospital [2]
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Mog001 30026 - Southport
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment postcode(s) [2]
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- Southport
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Recruitment outside Australia
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB Biopharma SRL
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Ethics approval
Ethics application status
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Summary
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 (MOG-AD).
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Trial website
https://clinicaltrials.gov/study/NCT05063162
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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UCB Cares
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Address
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001 844 599 2273
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UCB Cares
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Phone
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1-844-599-2273 (USA)
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05063162
Download to PDF