This study is in progress, not accepting new patients

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

a study on Myasthenia Gravis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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)

Keywords

Generalized Myasthenia Gravis, monoclonal antibody, batoclimab, IMVT-1401, Myasthenia Gravis, acetylcholine receptor, RVT-1401, Muscle Weakness, Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly, Batoclimab 340 mg SC bi-weekly

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Are ≥ 18 years of age at the Screening Visit.
  2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
  3. Have a QMG score ≥ 11 at the Screening and Baseline Visits.
  4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
  5. Additional inclusion criteria are defined in the protocol.

You CAN'T join if...

  1. Have experienced myasthenic crisis within 3 months of the Screening Visit.
  2. Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
  3. Have any active or untreated malignant thymoma.
  4. Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies) within the past year.
  5. Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRn treatment.
  6. Additional exclusion criteria are defined in the protocol.

Locations

  • Site Number -1032
    San Francisco California 94143 United States
  • Site Number - 1012
    Olive View California 91342 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunovant Sciences GmbH
ID
NCT05403541
Phase
Phase 3 Myasthenia Gravis Research Study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated