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Clinical trial

A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis

ID
Name
RA101495-02.302
Description
The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.
Trial arms
Trial start
2019-12-23
Estimated PCD
2026-05-20
Trial end
2026-05-20
Status
Active (not recruiting)
Phase
Early phase I
Treatment
zilucoplan (RA101495)
Daily subcutaneous (SC) injection
Arms:
0.3 mg/kg zilucoplan (RA101495)
Size
200
Primary endpoint
Incidence of treatment-emergent adverse events (TEAEs)
From Baseline (Day 1) to Safety Follow-Up Visit (up to 36 months)
Eligibility criteria
Inclusion Criteria: * Completion of a qualifying zilucoplan study Exclusion Criteria: * With the exception of a prior zilucoplan trial, participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2024-05-01

1 organization

1 product

1 indication

Organization
Ra Pharmaceuticals
Product
Zilucoplan
Indication
Myasthenia Gravis