CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Zilucoplan (RA101495)drug
Likely dose
Zilucoplan (RA101495) 0.3mg/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.

Search/NCT03078582
NCT03078582Phase 2Completed
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Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria

Ra Pharmaceuticals·interventional·Posted Mar 13, 2017·Updated Jul 27, 2022

In Brief

A Phase 2 clinical trial evaluating Zilucoplan (RA101495) for Paroxysmal Nocturnal Hemoglobinuria (PNH). Completed, enrolled 26 participants across 12 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria (PNH)
CountriesAustralia, Canada, Denmark, Finland, Germany, Hungary, New Zealand, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 13, 2017
Enrollment StartMar 8, 2017
Primary CompletionMar 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.3 years ago

Interventions

Zilucoplan (RA101495)drug

0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC