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NCT05389449 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Alexion Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
80
Enrollment target
20
Study locations

NCT05389449 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria that is active but no longer recruiting, run by Alexion Pharmaceuticals. The registered enrollment target is 80 participants, below the 259-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT05389449, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, is active but no longer recruiting, sponsored by Alexion Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
80 participants
Enrollment target
20
Study locations

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 Studied

Paroxysmal Nocturnal Hemoglobinuria

Interventions

  • DRUG Danicopan

Study Locations (20)

Other

  • Research Site - Porto Alegre
  • Research Site - Rio de Janeiro
  • Research Site - Brno
  • Research Site - Lille
  • Research Site - Paris
  • Research Site - Pessac
  • Research Site - Pierre-Bénite
  • Research Site - Athens
  • Research Site - Thessaloniki
  • Research Site - Haifa
  • Research Site - Jerusalem
  • Research Site - Avellino

California

  • Research Site - Los Angeles

Illinois

  • Research Site - Chicago

Maryland

  • Research Site - Baltimore

Missouri

  • Research Site - Kansas City

New York

  • Research Site - Long Island City

Ohio

  • Research Site - Cleveland

Texas

  • Research Site - Dallas

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2022-10-28
Est. Completion 2026-07-31
Phase Phase 3

Sponsor

Alexion Pharmaceuticals

162 total trials

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What the Registry Record Tells You About NCT05389449

The ClinicalTrials.gov registry entry for NCT05389449 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 259-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (69% lower). The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Paroxysmal Nocturnal Hemoglobinuria appearing as the primary indexed condition, and to 1 intervention - of which Danicopan is the first listed.

NCT05389449 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT05389449 about?

NCT05389449 is a clinical study titled "A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH". 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.

What is the current status of trial NCT05389449?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2022-10-28. Estimated completion is 2026-07-31.

What conditions does trial NCT05389449 study?

This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria.

What interventions are being tested in trial NCT05389449?

The interventions under investigation include: Danicopan (DRUG).

Who is sponsoring clinical trial NCT05389449?

This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05389449 being conducted?

This trial has 20 study locations across California, Illinois, Maryland, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.