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NCT03635112 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of TD-1473 in Crohn's Disease
A Phase 2 study, sponsored by Theravance Biopharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 167
- Enrollment target
NCT03635112: Clinical Trial Phase 2 study, sponsored by Theravance Biopharma.
NCT03635112 is a Phase 2 study that was terminated before completion, run by Theravance Biopharma. The registered enrollment target is 167 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635112, a Phase 2 study, was terminated before completion, sponsored by Theravance Biopharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 167 participants
- Enrollment target
Study Summary
A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
Primary Outcome
The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed
Interventions
- DRUG Placebo
- DRUG TD-1473
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2021-12-30 |
| Phase | Phase 2 |
Why NCT03635112 stopped before completion
NCT03635112 is an interventional study that assigns participants to a tested intervention. The registered 167 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 (26% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03635112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03635112 about?
NCT03635112 is a clinical study titled "Efficacy and Safety of TD-1473 in Crohn's Disease". A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
What is the current status of trial NCT03635112?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 167 participants. The study started on 2018-11-19. Estimated completion is 2021-12-30.
What interventions are being tested in trial NCT03635112?
The interventions under investigation include: Placebo (DRUG), TD-1473 (DRUG).
Who is sponsoring clinical trial NCT03635112?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03635112's enrollment target sits among peer trials
167 406th of 2000 higher than 1,595 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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