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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 is a Phase 3 study that has completed, run by Janssen-Cilag. The registered enrollment target is 215 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03782376
The ClinicalTrials.gov registry entry for NCT03782376 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen-Cilag, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo (SC) is the first listed.
NCT03782376 reports 0 study locations.
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.
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