At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 86 enrolled
Drug / intervention
Danicopan +2 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.
A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)
In Brief
A Phase 3 clinical trial evaluating Danicopan, Placebo, and 1 other intervention for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 86 participants across 62 sites in 18 countries.
Detailed Summary
The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesBrazil, Canada, Czechia, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Poland, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartDec 2020
Primary CompletionJun 2022
Study CompletionJan 2024
TodayJul 2026
First PostedJul 14, 2020
Enrollment StartDec 16, 2020
Primary CompletionJun 29, 2022
Study CompletionJan 16, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.0 years ago
Interventions
Danicopandrug
Oral tablet
Placebodrug
Oral tablet
C5 Inhibitordrug
Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.