Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
Public ClinicalTrials.gov record NCT05403541. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05403541
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 233 participants
Conditions and interventions
Conditions
Interventions
- Batoclimab 680 mg SC weekly Drug
- Batoclimab 340 mg SC weekly Drug
- Matching Placebo SC Drug
- Batoclimab 340 mg SC bi-weekly Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2022 (Actual)
- Primary completion
- Jan 10, 2025 (Actual)
- Completion
- Aug 7, 2026 (Actual)
- Last update posted
- Sep 14, 2026
2022 – 2026
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Number -1022 | Phoenix | Arizona | 85028 | — |
| Site Number -1029 | Scottsdale | Arizona | 85251 | — |
| Site Number -1002 | Carlsbad | California | 92011 | — |
| Site Number -1009 | Irvine | California | 92697 | — |
| Site Number - 1012 | Olive View | California | 91342 | — |
| Site Number -1032 | San Francisco | California | 94143 | — |
| Site Number - 1027 | Aurora | Colorado | 80045 | — |
| Site Number - 1025 | New Haven | Connecticut | 06519 | — |
| Site Number -1007 | Clearwater | Florida | 33761 | — |
| Site Number -1010 | Maitland | Florida | 32751 | — |
| Site Number - 1020 | Miami | Florida | 33136 | — |
| Site Number - 1019 | Orlando | Florida | 32806 | — |
| Site Number - 1028 | Port Charlotte | Florida | 33952 | — |
| Site Number - 1015 | Tampa | Florida | 33612 | — |
| Site Number -1011 | Fairway | Kansas | 66205 | — |
| Site Number -1003 | Lexington | Kentucky | 40536 | — |
| Site Number -1013 | East Lansing | Michigan | 48824 | — |
| Site Number - 1024 | Minneapolis | Minnesota | 55414 | — |
| Site Number - 1021 | Buffalo | New York | 14203 | — |
| Site Number - 1018 | Chapel Hill | North Carolina | 27599 | — |
| Site Number - 1008 | Durham | North Carolina | 27710 | — |
| Site Number -1004 | Cleveland | Ohio | 44195 | — |
| Site Number -1006 | Portland | Oregon | 97239 | — |
| Site Number - 1023 | Philadelphia | Pennsylvania | 19104 | — |
| Site Number - 1026 | Memphis | Tennessee | 38120 | — |
| Site Number -1001 | Austin | Texas | 78759 | — |
| Site Number -1016 | Dallas | Texas | 75206 | — |
| Site Number - 1034 | Houston | Texas | 77030 | — |
| Site Number - 1014 | Round Rock | Texas | 78681 | — |
| Site Number -1005 | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05403541, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2026 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05403541 live on ClinicalTrials.gov.