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A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

NCT05019521 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2025-09-05

Study results available
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Summary

This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.

Conditions

Interventions

DRUG

Danicopan

Oral tablet.

DRUG

Placebo

Oral tablet.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2024-07-05
Completion
2025-01-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Latvia
  • Slovakia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT05019521 on ClinicalTrials.gov