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NCT04987307 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 221
- Enrollment target
NCT04987307: Clinical Trial Phase 2 study, sponsored by Amgen.
NCT04987307 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 221 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04987307, a Phase 2 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 221 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.
Primary Outcome
Clinical remission was defined as a modified Mayo score of 0 to 2, including a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and a centrally read endoscopy subscore of 0 or 1 (modified so that 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.
Interventions
- DRUG Placebo
- DRUG Efavaleukin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2022-01-31 |
| Est. Completion | 2024-10-22 |
| Phase | Phase 2 |
Why NCT04987307 stopped before completion
NCT04987307 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04987307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04987307 about?
NCT04987307 is a clinical study titled "Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis". The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction ...
What is the current status of trial NCT04987307?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 221 participants. The study started on 2022-01-31. Estimated completion is 2024-10-22.
What interventions are being tested in trial NCT04987307?
The interventions under investigation include: Placebo (DRUG), Efavaleukin alfa (DRUG).
Who is sponsoring clinical trial NCT04987307?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04987307's enrollment target sits among peer trials
221 275th of 2000 higher than 1,726 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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