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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) Drug: Satralizumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : August 30, 2022
Estimated Primary Completion Date : October 10, 2025
Estimated Study Completion Date : December 27, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Annualized rate of adjudicated MOGAD relapses [ Time Frame: Up to approximately 44 months ]
  2. Annualized rate of active lesions on MRI of the neuroaxis [ Time Frame: Up to approximately 44 months ]
  3. Proportion of participants receiving rescue therapy [ Time Frame: Up to approximately 44 months ]
  4. Annualized rate of inpatient hospitalizations [ Time Frame: Up to approximately 44 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05271409


Contacts
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Contact: Reference Study ID Number: WN43194, https://forpatients.roche.com/ 888-662-6728 (U.S.) global-roche-genentech-trials@gene.com

Locations
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United States, District of Columbia
Medstar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Germany
St. Josef-Hospital, Klinik für Neurologie Recruiting
Bochum, Germany, 44791
Vestische Kinder- und Jugendklinik Datteln Recruiting
Datteln, Germany, 45711
Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla Recruiting
Milano, Lombardia, Italy, 20132
Fondazione Istituto Neurologico Mondino IRCCS Recruiting
Pavia, Lombardia, Italy, 27100
Japan
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Tohoku Medical and Pharmaceutical University Hospital Recruiting
Miyagi, Japan, 983-8512
The Jikei University Hospital Recruiting
Tokyo, Japan, 105-8471
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Korea, Republic of, 10408
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Hoffmann-La Roche
Chugai Pharmaceutical
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05271409    
Other Study ID Numbers: WN43194
First Posted: March 9, 2022    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No