Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04673357 · ClinicalTrials.gov registry record · Phase 3
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT04673357: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT04673357 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04673357, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active Crohn's disease.
Primary Outcome
Clinical remission was defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \<=10. The 11-item PCDAI covered five general disease activity domains: symptom history scores (3 items: abdominal pain, stool frequency, and general well-being); laboratory scores (3 items: hematocrit \[HCT\], erythrocyte sedimentation rate \[ESR\], Albumin); growth scores (2 items: weight and height); physical examination scores (2 items: abdomen and perirectal disease); and extraintestinal manifestation
Interventions
- DRUG Placebo
- DRUG Ustekinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-04-06 |
| Est. Completion | 2025-03-03 |
| Phase | Phase 3 |
What the finished NCT04673357 record still lists
NCT04673357 is an interventional study that assigns participants to a tested intervention. The registered 101 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 (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04673357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04673357 about?
NCT04673357 is a clinical study titled "A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease". The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely acti...
What is the current status of trial NCT04673357?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2021-04-06. Estimated completion is 2025-03-03.
What interventions are being tested in trial NCT04673357?
The interventions under investigation include: Placebo (DRUG), Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT04673357?
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 NCT04673357's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04033497 · 101 participants · NA
Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases
- NCT05111574 · 101 participants · Phase 2
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
- NCT05984680 · 101 participants
COPD Care Pathway Among Patients With Cancer
- NCT06266299 · 101 participants · Phase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI