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Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
NCT05403541 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05403541
The ClinicalTrials.gov registry entry for NCT05403541 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immunovant Sciences, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05403541 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05403541?
This trial is sponsored by Immunovant Sciences, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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