Trial Details

Not Recruiting
Basic Information
Clinical ID c3233
Identifier EUCTR2010-022759-42-DE
Trial Title A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease - UNITI 2
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Moderately to severely active Crohn's disease MedDRA version: 17.1_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 INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: N/A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use
Participant Information
Sponsor Janssen-Cilag International N.V.
City -
Country/Region United States;Spain;Israel;Russia;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;South Korea
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -