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NCT02264639 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH
A Phase 1 study, sponsored by Apellis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT02264639: Completed Phase 1 study, sponsored by Apellis Pharmaceuticals.
NCT02264639 is a Phase 1 study that has completed, run by Apellis Pharmaceuticals. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02264639, a Phase 1 study, has completed, sponsored by Apellis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study will be the initial exploration of pegcetacoplan in patients with PNH. The assessments of the safety, tolerability, PK, and PD following administration of single and multiples doses of pegcetacoplan will guide decisions to further develop the drug.
Primary Outcome
TEAEs were defined as AEs that developed or worsened after first dose of study drug (Day 1), and up to 30 days after last dose of study drug. The Investigator assessed AEs for severity and relatedness to study drug. AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.
Interventions
- DRUG Pegcetacoplan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-02-23 |
| Est. Completion | 2018-10-22 |
| Phase | Phase 1 |
What the finished NCT02264639 record still lists
NCT02264639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Pegcetacoplan is the first listed.
NCT02264639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02264639 about?
NCT02264639 is a clinical study titled "A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH". This study will be the initial exploration of pegcetacoplan in patients with PNH. The assessments of the safety, tolerability, PK, and PD following administration of single and multiples doses of pegcetacoplan will guide decisions to further develop the drug.
What is the current status of trial NCT02264639?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2015-02-23. Estimated completion is 2018-10-22.
What interventions are being tested in trial NCT02264639?
The interventions under investigation include: Pegcetacoplan (DRUG).
Who is sponsoring clinical trial NCT02264639?
This trial is sponsored by Apellis Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02264639's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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