Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (NCT05403541)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Site Number -1022 — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (93 Sites)
Showing the first 25 of 93 sites.
- Site Number -1022 — Phoenix, Arizona
- Site Number -1029 — Scottsdale, Arizona
- Site Number -1002 — Carlsbad, California
- Site Number -1009 — Irvine, California
- Site Number - 1012 — Olive View, California
- Site Number -1032 — San Francisco, California
- Site Number - 1027 — Aurora, Colorado
- Site Number - 1025 — New Haven, Connecticut
- Site Number -1007 — Clearwater, Florida
- Site Number -1010 — Maitland, Florida
- Site Number - 1020 — Miami, Florida
- Site Number - 1019 — Orlando, Florida
- Site Number - 1028 — Port Charlotte, Florida
- Site Number - 1015 — Tampa, Florida
- Site Number -1011 — Fairway, Kansas
- Site Number -1003 — Lexington, Kentucky
- Site Number -1013 — East Lansing, Michigan
- Site Number - 1024 — Minneapolis, Minnesota
- Site Number - 1021 — Buffalo, New York
- Site Number - 1018 — Chapel Hill, North Carolina
- Site Number - 1008 — Durham, North Carolina
- Site Number -1004 — Cleveland, Ohio
- Site Number -1006 — Portland, Oregon
- Site Number - 1023 — Philadelphia, Pennsylvania
- Site Number - 1026 — Memphis, Tennessee
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Generalized Myasthenia Gravis
- A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis — Scottsdale, Arizona
- A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis — Scottsdale, Arizona
- Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis — Orange, California
- Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis — Los Angeles, California
- A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. — Scottsdale, Arizona
Explore by condition: All Generalized Myasthenia Gravis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.