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NCT03943446 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
A Phase 2 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT03943446: Clinical Trial Phase 2 study, sponsored by Takeda.
NCT03943446 is a Phase 2 study that was terminated before completion, run by Takeda. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03943446, a Phase 2 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after abdominal resection surgery in adults with Crohn's disease. Participants will take either TAK-018 or placebo tablets by mouth, 2 times each day for up to 26 weeks after surgery. The placebo looks like TAK-018 but will not have any medicine in it. Participants will have 6 study visits while receiving treatment. Visits 1 and 6 will be conducted at the study clinic. The others can be in the clinic or at the participant's home. Follow-up will occur 4 weeks after final treatment.
Primary Outcome
Endoscopic recurrence (ER) is defined as a Rutgeerts' score ≥ i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The total score ranges from i0 to i4; where i0 = no lesions, i1= ≤ 5 aphthous ulcers, i2= \> 5 aphthous ulcers with normal mucosa between lesions or lesions are confined to the anastomosis, i3= diffuse aphthous ileitis with diffusely inflamed mucosa and i4= diffuse inflammation with larger ulcers,
Interventions
- DRUG TAK-018
- DRUG TAK-018 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2020-08-04 |
| Est. Completion | 2022-08-25 |
| Phase | Phase 2 |
Why NCT03943446 stopped before completion
NCT03943446 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which TAK-018 is the first listed.
NCT03943446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03943446 about?
NCT03943446 is a clinical study titled "A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery". The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after abdominal resection surgery in adults with Crohn's disease. Participants will take either TAK-018 or placebo tablets by mouth, 2 times each day for up to 26 weeks after surgery. The placebo looks like TAK-018 ...
What is the current status of trial NCT03943446?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2020-08-04. Estimated completion is 2022-08-25.
What interventions are being tested in trial NCT03943446?
The interventions under investigation include: TAK-018 (DRUG), TAK-018 Placebo (DRUG).
Who is sponsoring clinical trial NCT03943446?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03943446's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 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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