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Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
NCT04630028Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2021
- Primary completion
- May 2025
- Countries
- 9
- Sponsor
- Janssen Pharmaceutical
- Modality
- Monoclonal Antibodies
- Drugs
- ustekinumab
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 3, randomised, double-blind trial of ustekinumab in ulcerative colitis (UC) (3 arms), sponsored by Janssen Pharmaceutical. Primary endpoints: Percentage of Participants With Clinical Remission at 8 weeks, Number of Participants With Treatment-emergent Adverse Events at 52 weeks and 7 more. Started Mar 2021; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Induction Period (I): Ustekinumab
All participants receive a single IV administration of ustekinumab at induction Week 0.
Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Participants receive SC ustekinumab every 8 weeks and matching placebo at specific weeks to maintain the blind.
Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)
Participants receive SC ustekinumab every 12 weeks and matching placebo at specific weeks to maintain the blind.
03
Who it enrols
Pediatric participants with moderately to severely active ulcerative colitis (baseline Mayo score 6-12, screening Mayo endoscopy subscore >= 2). Excludes patients with UC limited to the rectum or <20 cm of the colon, history of bowel obstruction, latent/active granulomatous infection, or malignancy.
04
Endpoints
Primary
Percentage of Participants With Clinical Remission
Number of Participants With Treatment-emergent Adverse Events
Number of Participants With Treatment Emergent Serious Adverse Events
Number of Participants With AEs Leading to Discontinuation of Study Intervention
Number of Participants With Adverse Events of Special Interest
Secondary
Percentage of Participants With Clinical Response
Percentage of Participants With Symptomatic Remission
Percentage of Participants With Clinical Remission as Assessed by the Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Percentage of Participants With Endoscopic Improvement
Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
Percentage of Participants With Clinical Remission at Maintenance Week 44
Percentage of Participants With Corticosteroid-free Clinical Remission
Percentage of Participants With Clinical Remission at Maintenance Week 44 and Not Receiving Corticosteroids for At Least 90 Days Prior
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