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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

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)
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)
Secondary ID [1] 0 0
2021-000352-19
Secondary ID [2] 0 0
MOG001
Universal Trial Number (UTN)
Trial acronym
cosMOG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period
Timepoint [1] 0 0
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
Primary outcome [2] 0 0
For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period
Timepoint [2] 0 0
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
Primary outcome [3] 0 0
For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period
Timepoint [3] 0 0
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
Secondary outcome [2] 0 0
For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)
Timepoint [2] 0 0
Baseline (Week 1), EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
Secondary outcome [3] 0 0
For Part A: Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period
Timepoint [3] 0 0
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
Secondary outcome [4] 0 0
For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period
Timepoint [4] 0 0
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
Secondary outcome [5] 0 0
For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period
Timepoint [5] 0 0
Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)

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
Minimum age
18 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Mog001 30022 - Melbourne
Recruitment hospital [2] 0 0
Mog001 30026 - Southport
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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District of Columbia
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Florida
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Illinois
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Kansas
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Maryland
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Massachusetts
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Ohio
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Texas
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Utah
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Belgium
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Edegem
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Belgium
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Gent
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Brazil
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Porto Alegre
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Czechia
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Hradec Kralove
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Czechia
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Prague 2
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Teplice
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France
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Bron Cedex
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France
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Caen
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Marseille
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Montpellier
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Göttingen
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Germany
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ULM
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Italy
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Pavia
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Italy
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Roma
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Italy
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Verona
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Japan
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Bunkyo-ku
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Chiba-shi
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Isehara
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Sendai
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Shinjuku-ku
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Suita
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Goyang-si
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Seoul
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Mexico
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Ciudad de Mexico
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Mexico
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Culiacán
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Portugal
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Coimbra
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Barcelona
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Madrid
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Spain
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Murcia
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Spain
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Málaga
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Sweden
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Gothenburg
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Sweden
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Huddinge
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Switzerland
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Basel
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Switzerland
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Bern
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Taiwan
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Changhua County,changhua CITY
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Kaohsuing CITY
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Taipei City
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Taoyuan City
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Turkey
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Izmir
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Turkey
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I?stanbul
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Turkey
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Samsun
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Turkey
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Sancaktepe
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Ukraine
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Kyiv
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Ukraine
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Ternopil
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Liverpool
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
UCB Cares
Address 0 0
Country 0 0
Phone 0 0
1-844-599-2273 (USA)
Fax 0 0
Email 0 0
UCBCares@ucb.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.Vivli.org


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05063162