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NCT05470985 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT05470985: Clinical Trial Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT05470985 is a Phase 2 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05470985, a Phase 2 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
Primary Outcome
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abn
Interventions
- DRUG Ozanimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2024-09-13 |
| Phase | Phase 2 |
Why NCT05470985 stopped before completion
NCT05470985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Ozanimod is the first listed.
NCT05470985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05470985 about?
NCT05470985 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy". The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
What is the current status of trial NCT05470985?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2023-08-22. Estimated completion is 2024-09-13.
What interventions are being tested in trial NCT05470985?
The interventions under investigation include: Ozanimod (DRUG).
Who is sponsoring clinical trial NCT05470985?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05470985's enrollment target sits among peer trials
5 2000th of 2000 the lowest 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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