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A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

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: NCT04963270
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

Condition or disease Intervention/treatment Phase
Generalized Myasthenia Gravis Drug: Satralizumab Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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 Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : July 14, 2023
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Satralizumab
Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter
 Drug: Satralizumab
Satralizumab will be administered as a subcutaneous injection
Placebo Comparator: Placebo
Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter
 Other: Placebo
Satralizumab placebo will be administered as a subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in AChR-antibody seropositive population [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Mean change from baseline in Quantitative Myasthenia Gravis (QMG) score [ Time Frame: Week 24 ]
  2. Mean change from baseline in Myasthenia Gravis Quality of Life 15 Scale (MG-QOL 15r) score [ Time Frame: Week 24 ]
  3. Mean change from baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale score [ Time Frame: Week 24 ]
  4. Mean change from baseline in total Myasthenia Gravis Composite (MGC) score [ Time Frame: Week 24 ]
  5. Proportion of MG-ADL responders [ Time Frame: Week 24 ]
  6. Proportion of QMG responder [ Time Frame: Week 24 ]
  7. Proportion of MGC responders [ Time Frame: Week 24 ]
  8. Proportion of participants who have achieved minimal disease manifestation (total MG-ADL score of 0 or 1) [ Time Frame: Week 24 ]

Eligibility Criteria
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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:

  • Signed Informed Consent Form
  • For adolescent patients: Informed Consent Form for study participation signed by the parents or a legal guardian, and patient assent obtained, as per local requirements
  • Ability to comply with the study protocol procedures
  • Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
  • A total MG-ADL score of ≥ 5 points at screening with more than 50% of this score attributed to non-ocular items
  • MGFA severity Class II-IV
  • Ongoing gMG treatment at a stable dose
  • For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab.

Exclusion Criteria:

  • History of thymectomy within 12 months prior to screening
  • Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3 months prior to screening
  • Known disease other than gMG that would interfere with the course and conduct of the study
  • Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
  • Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose
Contacts and Locations
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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): NCT04963270


Contacts
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Contact: Reference Study ID Number: GE42063 https://forpatients.roche.com/ 888-662-6728 (U.S.) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04963270    
Other Study ID Numbers: WN42636
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases