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NCT05403541 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
A Phase 3 study of Generalized Myasthenia Gravis, sponsored by Immunovant Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT05403541: Active Phase 3 study of Generalized Myasthenia Gravis, sponsored by Immunovant Sciences.
NCT05403541 is a Phase 3 study of Generalized Myasthenia Gravis that is active but no longer recruiting, run by Immunovant Sciences. The registered enrollment target is 240 participants, above the 122-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (97% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05403541, a Phase 3 study of Generalized Myasthenia Gravis, is active but no longer recruiting, sponsored by Immunovant Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.
Primary Outcome
MG-ADL is an 8-item, participant-reported questionnaire that assesses gMG symptoms and their effects on activities of daily living. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. Total score ranges from 0 to 24, with higher scores indicating greater functional impairment and disability.
Conditions Studied
Interventions
- DRUG Batoclimab 340 mg SC weekly
- DRUG Batoclimab 680 mg SC weekly
- DRUG Matching Placebo SC
- DRUG Batoclimab 340 mg SC bi-weekly
Study Locations (20)
Florida
- Site Number -1007 - Clearwater
- Site Number -1010 - Maitland
- Site Number - 1020 - Miami
- Site Number - 1019 - Orlando
- Site Number - 1028 - Port Charlotte
- Site Number - 1015 - Tampa
California
- Site Number -1002 - Carlsbad
- Site Number -1009 - Irvine
- Site Number - 1012 - Olive View
- Site Number -1032 - San Francisco
Arizona
- Site Number -1022 - Phoenix
- Site Number -1029 - Scottsdale
Colorado
- Site Number - 1027 - Aurora
Connecticut
- Site Number - 1025 - New Haven
Kansas
- Site Number -1011 - Fairway
Kentucky
- Site Number -1003 - Lexington
Michigan
- Site Number -1013 - East Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2022-06-27 |
| Est. Completion | 2027-01 |
| Phase | Phase 3 |
What the registry record for NCT05403541 still lists
NCT05403541 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 122-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (97% higher).
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 4 interventions - of which Batoclimab 340 mg SC weekly is the first listed.
NCT05403541 names 20 study sites across 11 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05403541 about?
NCT05403541 is a clinical study titled "Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis". The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint...
What is the current status of trial NCT05403541?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2022-06-27. Estimated completion is 2027-01.
What conditions does trial NCT05403541 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT05403541?
The interventions under investigation include: Batoclimab 340 mg SC weekly (DRUG), Batoclimab 680 mg SC weekly (DRUG), Matching Placebo SC (DRUG), Batoclimab 340 mg SC bi-weekly (DRUG).
Who is sponsoring clinical trial NCT05403541?
This trial is sponsored by Immunovant Sciences, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05403541 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05403541's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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