Trial Details

Authorised
Basic Information
Clinical ID c2709
Identifier EUCTR2018-002629-51-NL
Trial Title 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 Disease - Patient Optimization With ustekinumab Re-induction (POWER)
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Crohn Disease MedDRA version: 20.0_Level: PT_Classification code 10011401_Term: Crohn's disease_System Organ Class: 10017947 - Gastrointestinal disorders_;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Interventions Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Participant Information
Sponsor Janssen-Cilag International NV
City -
Country/Region United States;Czech Republic;Spain;Austria;Russia;United Kingdom;Italy;France;Netherlands;Germany;South Korea;Sweden
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -