Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE-XT)

UCB

Status and phase: Active, not recruiting; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Drug: zilucoplan (RA101495)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04225871

2024-512399-37 (Registry Identifier)

RA101495-02.302

U1111-1306-6625 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

0.3 mg/kg zilucoplan (RA101495)

Experimental group

Treatment:

Drug: zilucoplan (RA101495)