A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Patient Optimization With ustEkinumab Re-induction POWER)

About this Study

This is a randomized, double-blind, placebo-controlled, multicenter, 24-week, Phase 3b study in adult patients with active moderate to severe Crohn's disease who initially responded to ustekinumab induction therapy per label followed, at any time, by secondary lost of response (LoR) to SC q8w ustekinumab maintenance therapy. The benefit of a single weight-tiered based IV re-induction dose of 6 mg/kg body weight ustekinumab versus continuous SC q8w maintenance treatment will be evaluated.  This study is intending to evaluate the achievement of clinical response at Week 16 following a single IV re-induction dose of 6 mg/kg ustekinumab, compared with continuing regular SC q8w 90 mg ustekinumab administration, in participants with secondary loss of response (LoR) to SC q8w 90 mg ustekinumab maintenance therapy.

Sponsor Protocol ID:CNTO1275CRD3008
IRB Number:2019-0273
Actively Enrolling
Interventional
Phase 3
December 04, 2019
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria
1. Male or female aged 18 years (or the legal age of consent in the jurisdiction in which the study is taking place if older than 18 years).

2. A history of Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration.

3. A female participant must be: 
 Not of childbearing potential 

Exclusion Criteria
1. Known to have had a substance abuse (drug or alcohol) problem within the 12 months before baseline. 

2. A woman who is pregnant, or breastfeeding, or planning to become pregnant, or is a man who plans to father a child while enrolled in this study or within 15 weeks after the last dose of study intervention. 

Categories Click category to view its trials.
Digestive Conditions
Participating Locations
Belhaven - University Physicians
University Hospital
Contact Information
Contact Name: Yilianys Pride
Phone Number: 601-984-1640
Email: ypride@umc.edu
Principal Investigator:Glover, Sarah C, D.O.
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