Trials / Completed
CompletedNCT03078582
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients
Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Ra Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and efficacy of zilucoplan (RA101495) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients in the study: the first group will include patients who have never received eculizumab for treatment of PNH. The second group will include patients who have received treatment with eculizumab for at least 6 months prior to the study. Patients will be treated with RA101495 for 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zilucoplan (RA101495) | 0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC |
Timeline
- Start date
- 2017-03-08
- Primary completion
- 2018-03-28
- Completion
- 2018-03-28
- First posted
- 2017-03-13
- Last updated
- 2022-07-27
- Results posted
- 2020-03-10
Locations
12 sites across 8 countries: Australia, Canada, Denmark, Finland, Germany, Hungary, New Zealand, United Kingdom
Source: ClinicalTrials.gov record NCT03078582. Inclusion in this directory is not an endorsement.