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NCT03283085 · ClinicalTrials.gov registry record · Phase 3
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 557
- Enrollment target
NCT03283085: Completed Phase 3 study, sponsored by Shire.
NCT03283085 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 557 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03283085, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 557 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product.
Interventions
- DRUG 25 mg Ontamalimab
- DRUG 75 mg Ontamalimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 557 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2023-12-13 |
| Phase | Phase 3 |
What the finished NCT03283085 record still lists
NCT03283085 is an interventional study that assigns participants to a tested intervention. The registered 557 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which 25 mg Ontamalimab is the first listed.
NCT03283085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03283085 about?
NCT03283085 is a clinical study titled "A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)". The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
What is the current status of trial NCT03283085?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 557 participants. The study started on 2018-02-27. Estimated completion is 2023-12-13.
What interventions are being tested in trial NCT03283085?
The interventions under investigation include: 25 mg Ontamalimab (DRUG), 75 mg Ontamalimab (DRUG).
Who is sponsoring clinical trial NCT03283085?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03283085's enrollment target sits among peer trials
557 674th of 2000 higher than 1,326 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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