At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 80 enrolled
Drug / intervention
Pegcetacoplan +1 moredrug
Likely dose
Not stated in 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 III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
In Brief
A Phase 3 clinical trial evaluating Pegcetacoplan and Soliris for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 80 participants across 53 sites in 11 countries.
Detailed Summary
Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesAustralia, Belgium, Canada, France, Germany, Japan, Russia, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartJun 2018
Primary CompletionNov 2019
Study CompletionAug 2020
TodayJul 2026
First PostedApr 18, 2018
Enrollment StartJun 14, 2018
Primary CompletionNov 14, 2019
Study CompletionAug 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.2 years ago
Interventions
Pegcetacoplandrug
Complement (C3) Inhibitor
Solirisdrug
Complement (C5) Inhibitor