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NCT03943550 · ClinicalTrials.gov registry record · Phase 1
Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03943550: Clinical Trial Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03943550 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03943550, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was defi
Interventions
- DRUG Placebo
- DRUG RO7049665
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2021-07-22 |
| Phase | Phase 1 |
Why NCT03943550 stopped before completion
NCT03943550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03943550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03943550 about?
NCT03943550 is a clinical study titled "Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)". The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).
What is the current status of trial NCT03943550?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2019-05-13. Estimated completion is 2021-07-22.
What interventions are being tested in trial NCT03943550?
The interventions under investigation include: Placebo (DRUG), RO7049665 (DRUG).
Who is sponsoring clinical trial NCT03943550?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03943550's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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