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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 2

Conditions

Inflammation

Crohn's Disease

Treatments

Drug: NNC 0142-0000-0002

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01203631

2010-020836-21 (EudraCT Number)

U1111-1116-2695 (Other Identifier)

NN8555-3797

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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