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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-03-25

No results posted yet for this 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

Interventions

DRUG

Batoclimab 680 mg SC weekly

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

DRUG

Batoclimab 340 mg SC weekly

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

DRUG

Matching Placebo SC

Placebo

DRUG

Batoclimab 340 mg SC bi-weekly

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Sponsors & Collaborators

  • Immunovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2025-01-10
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Poland
  • Romania
  • Serbia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05403541 on ClinicalTrials.gov