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A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH

NCT05389449 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-16

No results posted yet for this study

Summary

This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.

Conditions

Interventions

DRUG

Danicopan

Oral tablet

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Czechia
  • France
  • Greece
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Poland
  • South Korea
  • Spain
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05389449 on ClinicalTrials.gov