CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
LFG316 +1 morebiological
Likely dose
LFG316 20 mg/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/NCT02534909
NCT02534909Phase 2Completed
CompareCT.gov

An Open-label Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316, an Anti-C5 Monoclonal Antibody in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Novartis Pharmaceuticals·interventional·Posted Aug 28, 2015·Updated May 16, 2025

In Brief

A Phase 2 clinical trial evaluating LFG316 and LNP023 for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 10 participants across 7 sites in 3 countries.

Detailed Summary

The purpose of this study was to determine whether LFG316 can induce a hematological response, as measured by reduction in hemolytic activity, in patients with paroxysmal nocturnal hemoglobinuria (PNH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesCzechia, Japan, Lithuania
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 28, 2015
Enrollment StartSep 9, 2015
Primary CompletionMay 24, 2022
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 10.8 years ago

Interventions

LFG316biological

LFG316 20 mg/kg was administered to all patients enrolled in the study: * Treatment Periods 1 to 3: LFG316 20 mg/kg as i.v. infusion every 2 weeks * Treatment Period 4: LFG316 20 mg/kg as i.v. infusion every 2 weeks for 4 weeks (total 2 infusions).

LNP023drug

Treatment Period 4: LNP023 200 mg b.i.d. for approximately 20 weeks. Four capsules (each 50 mg) were administered each time study medication was taken.