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NCT03782376 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study, sponsored by Janssen-Cilag.
- Completed
- Registry status
- Phase 3
- Development phase
- 215
- Enrollment target
NCT03782376: Completed Phase 3 study, sponsored by Janssen-Cilag.
NCT03782376 is a Phase 3 study that has completed, run by Janssen-Cilag. The registered enrollment target is 215 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03782376, a Phase 3 study, has completed, sponsored by Janssen-Cilag.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 215 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
Primary Outcome
Clinical response was defined as greater than or equal to (\>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score \< 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted 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) and/or opiates, and general wel
Interventions
- DRUG Placebo (SC)
- DRUG Placebo (IV)
- DRUG Ustekinumab approximately 6 mg/kg (IV)
- DRUG Ustekinumab 90 mg (SC) Group 1
- DRUG Ustekinumab 90 mg (SC) Group 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2018-12-20 |
| Est. Completion | 2023-01-10 |
| Phase | Phase 3 |
What the finished NCT03782376 record still lists
NCT03782376 is an interventional study that assigns participants to a tested intervention. The registered 215 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 (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo (SC) is the first listed.
NCT03782376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03782376 about?
NCT03782376 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease". The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maint...
What is the current status of trial NCT03782376?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 215 participants. The study started on 2018-12-20. Estimated completion is 2023-01-10.
What interventions are being tested in trial NCT03782376?
The interventions under investigation include: Placebo (SC) (DRUG), Placebo (IV) (DRUG), Ustekinumab approximately 6 mg/kg (IV) (DRUG), Ustekinumab 90 mg (SC) Group 1 (DRUG), Ustekinumab 90 mg (SC) Group 2 (DRUG).
Who is sponsoring clinical trial NCT03782376?
This trial is sponsored by Janssen-Cilag, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03782376's enrollment target sits among peer trials
215 1334th of 2000 higher than 666 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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