CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Danicopan +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.

Search/NCT03472885
NCT03472885Phase 2Completed
CompareCT.gov

A Phase 2 Open-label Study of ACH-0144471 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have an Inadequate Response to Eculizumab Monotherapy

Alexion Pharmaceuticals, Inc.·interventional·Posted Mar 21, 2018·Updated Dec 12, 2023

In Brief

A Phase 2 clinical trial evaluating Danicopan and Eculizumab for Paroxysmal Nocturnal Hemoglobinuria (PNH). Completed, enrolled 12 participants across 5 sites in 3 countries.

Detailed Summary

To determine the effectiveness of ACH-0144471 (also known as danicopan and ALXN2040) in improving anemia when given with eculizumab for 24 weeks in participants with PNH. Danicopan dose may be increased within each participant, to a maximum of 200 milligrams (mg) three times daily (TID) based on safety and efficacy at protocol-specified time points.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria (PNH)
CountriesItaly, United Kingdom, United States
CollaboratorsAchillion, a wholly owned subsidiary of Alexion

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 21, 2018
Enrollment StartMay 8, 2018
Primary CompletionSep 20, 2019
Study CompletionJan 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.3 years ago

Interventions

Danicopandrug

Participants received a daily oral dose of danicopan TID during the treatment period.

Eculizumabdrug

Participants received intravenous eculizumab administered at the participant's usual dose and schedule.