Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy
Study Identifier:
ACH228-110
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: ALXN2050
Date
Dec 2019 - Apr 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: ALXN2050
Date
Dec 2019 - Apr 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Protocol Summary
The study will evaluate the efficacy and safety of the oral Factor D (FD) inhibitor ALXN2050 (ACH-0145228) monotherapy in patients with PNH that are treatment naïve, or patients currently treated with eculizumab who still experience anemia and reticulocytosis, or patients currently treated with ALXN2040 (danicopan) as monotherapy. After signing consent, participants will have periodic visits through Week 12, at which time the primary endpoint and key secondary assessments will be analyzed. Participants will continue on treatment past 12 weeks into a long-term extension portion of the trial.
Trial Locations
Location
Status
Location
Research Site
Toronto, Ontario, Canada, M5G2C4
Status
N/A
Location
Research Site
Levis, Quebec, Canada, G6V 3Z1
Status
N/A
Location
Research Site
Avellino, Italy, 83100
Status
N/A
Location
Research Site
Firenze, Italy, 50134
Status
N/A
Location
Research Site
Seoul, Republic of Korea, 06591
Status
N/A
Location
Research Site
Christchurch, New Zealand, 8011
Status
N/A