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NCT04102111 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
A Phase 2 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT04102111: Clinical Trial Phase 2 study, sponsored by Janssen Research & Development.
NCT04102111 is a Phase 2 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04102111, a Phase 2 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.
Primary Outcome
CDAI is a validated measure of illness severity derived as sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s)/opiates, and general well-being). Last 3 variables were scored over 7 days by participant on diary card. Score ranges from 0 to 600; higher score=higher disease activities. Participants who had incomplete data (less than or equa
Interventions
- DRUG Placebo
- DRUG JNJ-67864238
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-09-23 |
| Est. Completion | 2021-12-22 |
| Phase | Phase 2 |
Why NCT04102111 stopped before completion
NCT04102111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04102111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04102111 about?
NCT04102111 is a clinical study titled "A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease". The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.
What is the current status of trial NCT04102111?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2019-09-23. Estimated completion is 2021-12-22.
What interventions are being tested in trial NCT04102111?
The interventions under investigation include: Placebo (DRUG), JNJ-67864238 (DRUG).
Who is sponsoring clinical trial NCT04102111?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04102111's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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