At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 52 enrolled
Drug / intervention
Iptacopandrug
Likely dose
Iptacopan 200 mgfrom 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 Multicenter, Single Arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Have Hb≥10 g/dL in Response to Anti-C5 Antibody and Switch to Iptacopan
In Brief
A Phase 3 clinical trial evaluating Iptacopan for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 52 participants across 23 sites in 8 countries.
Detailed Summary
The purpose of the study was to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switched from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesFrance, Germany, Italy, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedNov 2022
Enrollment StartApr 2023
Primary CompletionOct 2024
TodayJul 2026
First PostedNov 29, 2022
Enrollment StartApr 24, 2023
Primary CompletionOct 17, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.6 years ago
Interventions
Iptacopandrug
Treatment with iptacopan at a dose of 200 mg b.i.d. will start on the first day (Day 1) and continue for 24 weeks.