At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
LNP023drug
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 Multi-center, Randomized, Open-label, Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria and Active Hemolysis
In Brief
A Phase 2 clinical trial evaluating LNP023 for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 13 participants across 5 sites in 4 countries.
Detailed Summary
This was a Phase II randomized, open-label, multicenter, efficacy, safety, pharmacokinetic and pharmacodynamic study assessing four iptacopan doses in adult Paroxysmal nocturnal hemoglobinuria (PNH) patients with active hemolysis who were not on eculizumab or any other complement inhibitor less than 3 months prior to first iptacopan dose. Active hemolysis was defined by a lactate dehydrogenase (LDH) value ≥ 1.5 × ULN.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesMalaysia, Singapore, South Korea, Taiwan
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 2019
Enrollment StartApr 2019
Primary CompletionApr 2020
Study CompletionFeb 2022
TodayJul 2026
First PostedMar 29, 2019
Enrollment StartApr 5, 2019
Primary CompletionApr 7, 2020
Study CompletionFeb 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.3 years ago
Interventions
LNP023drug
approximately 2 year of Treatment with LNP023