CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
Iptacopan (LNP023)drug
Likely dose
Iptacopan (LNP023) 200mgfrom 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/NCT04820530
NCT04820530Phase 3Completed
CompareCT.gov

A Multicenter, Single-arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy

Novartis Pharmaceuticals·interventional·Posted Mar 29, 2021·Updated Oct 9, 2024

In Brief

A Phase 3 clinical trial evaluating Iptacopan (LNP023) for Paroxysmal Nocturnal Hemoglobinuria (PNH). Completed, enrolled 40 participants across 12 sites in 8 countries.

Detailed Summary

The purpose of this Phase 3 study was to determine whether iptacopan is efficacious and safe for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH) patients who were naïve to complement inhibitor therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria (PNH)
CountriesChina, France, Germany, Italy, Malaysia, Singapore, South Korea, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 29, 2021
Enrollment StartJul 19, 2021
Primary CompletionNov 2, 2022
Study CompletionApr 18, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.3 years ago

Interventions

Iptacopan (LNP023)drug

Taken orally b.i.d. Dosage supplied: 200mg Dosage form: Hard gelatin capsule Route of Administration: oral