Trial Details

Not Recruiting
Basic Information
Clinical ID c3234
Identifier EUCTR2010-022758-18-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 Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Moderately to severely active Crohn's disease MedDRA version: 14.1_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 Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;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 -