Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
Phase 2
Completed
- Conditions
- InflammationCrohn's Disease
- Interventions
- Drug: NNC 0142-0000-0002Drug: Placebo
- Registration Number
- NCT01203631
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
- Subjects with CD for at least 3 months
- Subjects not treated before, or subjects who have either not responded to treatment, or responded and then lost the response during continued administration of a therapeutic compound
Exclusion Criteria
- Any of the following: Symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess
- History of dysplasia or malignancy in the colon
- Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation
- Body mass index (BMI) higher or equal to 38.0 kg/m^2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NNC 0142-0000-0002 NNC 0142-0000-0002 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in disease activity assessed by CDAI (Crohn's disease activity index) From baseline to week 4
- Secondary Outcome Measures
Name Time Method Number of adverse events (AEs) From baseline to weeks 12 and 24 Immunogenicity of NNC 142-0002 At week 24
Trial Locations
- Locations (1)
Novo Nordisk Clinical Trial Call Center
🇺🇸Milwaukee, Wisconsin, United States