Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

• Status: Completed
• Trial end date: 2020-11-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ra Pharmaceuticals

Criteria

Inclusion Criteria:

• Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IVa] at Screening

• Positive serology for acetylcholine receptor (AChR) autoantibodies

• QMG score ≥ 12 at Screening and Randomization

• No change in corticosteroid dose for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period

• No change in immunosuppressive therapy, including dose, for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period

Exclusion Criteria:

• Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12 week Treatment Period

• History of meningococcal disease

• Current or recent systemic infection within 2 weeks prior to Randomization or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization