A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
NCT04963270 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188
Last updated 2025-02-28
Summary
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
Conditions
Interventions
- DRUG
-
Satralizumab will be administered as a subcutaneous injection
- OTHER
-
Placebo
Satralizumab placebo will be administered as a subcutaneous injection
Sponsors & Collaborators
-
Chugai Pharmaceutical
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-19
- Primary Completion
- 2024-01-29
- Completion
- 2024-09-02
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Brazil
- Canada
- China
- Denmark
- France
- Germany
- Italy
- Japan
- Poland
- Russia
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
Study Locations
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