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

Conditions

• Generalized Myasthenia Gravis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Batoclimab 680 mg SC weekly — DRUG
  Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
• Batoclimab 340 mg SC weekly — DRUG
  Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
• Matching Placebo SC — DRUG
  Placebo
• Batoclimab 340 mg SC bi-weekly — DRUG
  Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Study Details

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.

Key Dates

Start date

Jun 27, 2022

Status verified

Jun 2026

Primary completion

Jan 10, 2025

Completion

Feb 28, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Batoclimab Induction Dose 1 (Period 1)
• Experimental: Batoclimab Induction Dose 2 (Period 1)
• Placebo Comparator: Placebo Induction Dose (Period 1)
• Experimental: Batoclimab Maintenance Dose 1 (Period 2)
• Experimental: Batoclimab Maintenance Dose 2 (Period 2)
• Placebo Comparator: Placebo Maintenance Dose (Period 2)

Primary Outcome Measure

Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants [ Time Frame: Baseline (Day 1) to Week 12 ]

Locations (30)

Related coverage on Hipa.ai

• Batoclimab Phase 3 for Generalized Myasthenia Gravis Reaches Primary Completion
  Batoclimab · Jan 10, 2025 · ClinicalTrials.gov

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