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NCT03566823 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
A Phase 3 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT03566823: Clinical Trial Phase 3 study, sponsored by Shire.
NCT03566823 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03566823, a Phase 3 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
Primary Outcome
Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain less than or equal to (\<=) 3 (based on 11 point numerical rating scale \[NRS\] ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]); and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but
Interventions
- OTHER Placebo
- BIOLOGICAL Ontamalimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2020-08-18 |
| Phase | Phase 3 |
Why NCT03566823 stopped before completion
NCT03566823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03566823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03566823 about?
NCT03566823 is a clinical study titled "Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)". The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
What is the current status of trial NCT03566823?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2018-07-17. Estimated completion is 2020-08-18.
What interventions are being tested in trial NCT03566823?
The interventions under investigation include: Placebo (OTHER), Ontamalimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03566823?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03566823's enrollment target sits among peer trials
34 1905th of 2000 higher than 94 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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