At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 3 enrolled
Drug / intervention
Zilucoplan (RA101495)drug
Likely dose
Zilucoplan (RA101495) 0.3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have an Inadequate Response to Eculizumab
In Brief
A Phase 2 clinical trial evaluating Zilucoplan (RA101495) for Paroxysmal Nocturnal Hemoglobinuria (PNH). Completed, enrolled 3 participants across 6 sites.
Detailed Summary
The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab. Patients will be treated with RA101495 for 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartApr 2017
Primary CompletionMar 2018
TodayJul 2026
First PostedJan 24, 2017
Enrollment StartApr 17, 2017
Primary CompletionMar 28, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.4 years ago
Interventions
Zilucoplan (RA101495)drug
0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC