Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT01203631
• Date of registration: 15/09/2010
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
• Scientific title: A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
• Date of first enrolment: February 2011
• Target sample size: 78
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01203631
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, France, Hungary, Israel, Poland, Russian Federation, United States

Contacts

• Name: Najat EL Bariaki
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammation

Crohn's Disease

Intervention(s)

Drug: NNC 0142-0000-0002

Drug: Placebo

Primary Outcome(s)

Change in disease activity assessed by CDAI (Crohn's disease activity index) [Time Frame: From baseline to week 4]

Secondary Outcome(s)

Immunogenicity of NNC 142-0002 [Time Frame: At week 24]

Number of adverse events (AEs) [Time Frame: From baseline to weeks 12 and 24]

Secondary ID(s)

U1111-1116-2695

NN8555-3797

2010-020836-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors