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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05271409




Registration number
NCT05271409
Ethics application status
Date submitted
28/02/2022
Date registered
9/03/2022

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab As Monotherapy Or In Addition To Baseline Therapy In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Secondary ID [1] 0 0
WN43194
Universal Trial Number (UTN)
Trial acronym
Meteoroid
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Satralizumab
Other interventions - Placebo

Experimental: Group A: Satralizumab - In the double-blind treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.

Placebo comparator: Group B: Placebo - In the double-blind treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.


Treatment: Drugs: Satralizumab
Study drug will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.

Other interventions: Placebo
Placebo will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.
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
Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC)
Timepoint [1] 0 0
Up to approximately 44 months
Secondary outcome [1] 0 0
Annualized rate of adjudicated MOGAD relapses
Timepoint [1] 0 0
Up to approximately 44 months
Secondary outcome [2] 0 0
Annualized rate of active lesions on MRI of the neuroaxis
Timepoint [2] 0 0
Up to approximately 44 months
Secondary outcome [3] 0 0
Proportion of participants receiving rescue therapy
Timepoint [3] 0 0
Up to approximately 44 months
Secondary outcome [4] 0 0
Annualized rate of inpatient hospitalizations
Timepoint [4] 0 0
Up to approximately 44 months

Eligibility
Key inclusion criteria
Inclusion criteria

* Participants who are aged >=12 years at the time of signing Informed Consent Form
* Confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening
* Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
* Best corrected visual acuity (HCVA) better than 20/800 in each eye at screening
* Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
* For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

* Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
* History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
* Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study
* Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
* Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
* Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
* Participants with positive screening tests for hepatitis B and C
* Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
* History of severe allergic reaction to a biologic agent

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 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
30/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Brain and Mind Research Institute - Camperdown
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [4] 0 0
Royal North Shore Hospital; Department of Neurology - St Leonards
Recruitment hospital [5] 0 0
Box Hill Hospital; Department of Neurology - Box Hill
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Royal Melbourne Hospital; Department of Neurology - Parkville
Recruitment hospital [9] 0 0
Perron Institute for Neurological and Translational Science - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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California
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Jerusalem
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Lazio
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Piemonte
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Sicilia
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Veneto
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Chiba
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Tokyo
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Chugai Pharmaceutical
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: WN43194, https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S.)
Fax 0 0
Email 0 0
[email protected]
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?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT05271409