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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 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 221 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04987307
The ClinicalTrials.gov registry entry for NCT04987307 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04987307 reports 0 study locations.
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.
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