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NCT03616821 · ClinicalTrials.gov registry record · Phase 2
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 2
- Development phase
- 242
- Enrollment target
NCT03616821: Clinical Trial Phase 2 study, sponsored by AstraZeneca.
NCT03616821 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 242 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03616821, a Phase 2 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 242 participants
- Enrollment target
Study Summary
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy
Primary Outcome
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses * stool frequency, * rectal bleeding, * endoscopic findings, and * physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease. The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease). Clinical Remis
Interventions
- DRUG Placebo
- DRUG Brazikumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2018-08-07 |
| Est. Completion | 2023-10-23 |
| Phase | Phase 2 |
Why NCT03616821 stopped before completion
NCT03616821 is an interventional study that assigns participants to a tested intervention. The registered 242 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 (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03616821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03616821 about?
NCT03616821 is a clinical study titled "Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis". The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on...
What is the current status of trial NCT03616821?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2018-08-07. Estimated completion is 2023-10-23.
What interventions are being tested in trial NCT03616821?
The interventions under investigation include: Placebo (DRUG), Brazikumab (DRUG).
Who is sponsoring clinical trial NCT03616821?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03616821's enrollment target sits among peer trials
242 237th of 2000 higher than 1,762 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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