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NCT03226678 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
A Phase 2 study, sponsored by Apellis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT03226678: Completed Phase 2 study, sponsored by Apellis Pharmaceuticals.
NCT03226678 is a Phase 2 study that has completed, run by Apellis Pharmaceuticals. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03226678, a Phase 2 study, has completed, sponsored by Apellis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
Primary Outcome
TEAEs were defined as adverse events (AEs) that occurred after dosing on Day 1 and up to 56 days after the last dose of study drug. A treatment-related TEAE is defined as a TEAE with a relationship to study drug of probably, possibly, unlikely, or unrelated. A serious adverse event (SAE) is defined as any AE that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant incapacity or substantial disruption
Interventions
- DRUG APL-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-08-31 |
| Est. Completion | 2022-09-12 |
| Phase | Phase 2 |
What the finished NCT03226678 record still lists
NCT03226678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which APL-2 is the first listed.
NCT03226678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03226678 about?
NCT03226678 is a clinical study titled "Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)". This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
What is the current status of trial NCT03226678?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2017-08-31. Estimated completion is 2022-09-12.
What interventions are being tested in trial NCT03226678?
The interventions under investigation include: APL-2 (DRUG).
Who is sponsoring clinical trial NCT03226678?
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 NCT03226678's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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