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Trial record 1 of 2 for:    MOGAD
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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (Meteoroid)

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ClinicalTrials.gov Identifier: NCT05271409
Recruitment Status : Recruiting
First Posted : March 9, 2022
Last Update Posted : November 22, 2022
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE February 28, 2022
First Posted Date  ICMJE March 9, 2022
Last Update Posted Date November 22, 2022
Actual Study Start Date  ICMJE August 30, 2022
Estimated Primary Completion Date October 10, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2022)
Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC) [ Time Frame: Up to approximately 44 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2022)
  • Annualized rate of adjudicated MOGAD relapses [ Time Frame: Up to approximately 44 months ]
  • Annualized rate of active lesions on MRI of the neuroaxis [ Time Frame: Up to approximately 44 months ]
  • Proportion of participants receiving rescue therapy [ Time Frame: Up to approximately 44 months ]
  • Annualized rate of inpatient hospitalizations [ Time Frame: Up to approximately 44 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
Official Title  ICMJE 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)
Brief Summary The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Intervention  ICMJE
  • Drug: 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: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2022)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 27, 2027
Estimated Primary Completion Date October 10, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (BCVA) better than 20/800 in both eyes 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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: WN43194, https://forpatients.roche.com/ 888-662-6728 (U.S.) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Germany,   Italy,   Japan,   Korea, Republic of,   United States
Removed Location Countries Australia,   Brazil,   Canada,   China
 
Administrative Information
NCT Number  ICMJE NCT05271409
Other Study ID Numbers  ICMJE WN43194
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Chugai Pharmaceutical
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP