Pegcetacoplan Long Term Safety and Efficacy Extension Study
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Apellis Pharmaceuticals, Inc.
- Study ID
- NCT03531255
- Phase
- PHASE3
- Status
- Completed
Conditions
- PNH
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pegcetacoplan — DRUGComplement (C3) Inhibitor
Study Details
This is an Open-label, Non-Randomized, Multi-Center Extension Study. Eligible subjects will have previously completed a pegcetacoplan study.
Key Dates
- Start date
- Aug 27, 2018
- Status verified
- Mar 2026
- Primary completion
- Sep 4, 2025
- Completion
- May 19, 2026
Study Design
- Enrollment
- 137 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1,080 mg pegcetacoplan administered subcutaneously1,080mg pegcetacoplan administered subcutaneously twice weekly or every three days.
Primary Outcome Measure
Incidence and severity of treatment-emergent adverse events [ Time Frame: Baseline to 2 Years ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | - |
| Denver Health Medical Center | Denver | Colorado | 80204 | - |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32257 | - |
| Lakes Research | Miami | Florida | 33014 | - |
| Northwestern University | Chicago | Illinois | 60611 | - |
| Investigative Clinical Research of Indiana | Indianapolis | Indiana | 46260 | - |
| Duke University Medical Center | Durham | North Carolina | 27710 | - |
| Cleveland Clinic | Cleveland | Ohio | 44195 | - |
| Baptist Cancer Center | Memphis | Tennessee | 38120 | - |
Related coverage on Hipa.ai
- Pegcetacoplan PNH Long-Term Extension Study Completes Primary PhasePegcetacoplan · Nov 29, 2025 · ClinicalTrials.gov
- Pegcetacoplan Phase 3 Extension Study for PNH Reaches Primary CompletionPegcetacoplan · Sep 4, 2025 · ClinicalTrials.gov