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NCT03758443 · ClinicalTrials.gov registry record · Phase 2
Efficacy & Safety of TD-1473 in Ulcerative Colitis
A Phase 2 study, sponsored by Theravance Biopharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 239
- Enrollment target
NCT03758443: Clinical Trial Phase 2 study, sponsored by Theravance Biopharma.
NCT03758443 is a Phase 2 study that was terminated before completion, run by Theravance Biopharma. The registered enrollment target is 239 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03758443, a Phase 2 study, was terminated before completion, sponsored by Theravance Biopharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 239 participants
- Enrollment target
Study Summary
A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.
Primary Outcome
Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.
Interventions
- DRUG Placebo
- DRUG TD-1473 Dose A
- DRUG TD-1473 Dose B
- DRUG TD-1473 Dose C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2019-03-11 |
| Est. Completion | 2021-10-20 |
| Phase | Phase 2 |
Why NCT03758443 stopped before completion
NCT03758443 is an interventional study that assigns participants to a tested intervention. The registered 239 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 (80% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03758443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03758443 about?
NCT03758443 is a clinical study titled "Efficacy & Safety of TD-1473 in Ulcerative Colitis". A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.
What is the current status of trial NCT03758443?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 239 participants. The study started on 2019-03-11. Estimated completion is 2021-10-20.
What interventions are being tested in trial NCT03758443?
The interventions under investigation include: Placebo (DRUG), TD-1473 Dose A (DRUG), TD-1473 Dose B (DRUG), TD-1473 Dose C (DRUG).
Who is sponsoring clinical trial NCT03758443?
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 NCT03758443's enrollment target sits among peer trials
239 255th of 2000 higher than 1,746 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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