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

Inflammation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203631
• Other study ID #: NN8555-3797
• Secondary ID: 2010-020836-21U1
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2010
• Last updated: July 29, 2016
• Start date: February 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Healthcare ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyIsrael: Ministry of HealthPoland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical TrialsRussia: Ministry of Health of the Russian FederationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammation

Intervention

Drug:
• NNC 0142-0000-0002
A single dose administered subcutaneously (s.c., under the skin)
• Placebo
A single dose administered subcutaneously (s.c., under the skin)

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Anaheim	California
United States	Novo Nordisk Clinical Trial Call Center	Annapolis	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Asheville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Charlottesville	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Chesterfield	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Chevy Chase	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Fayetteville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Germantown	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Lakewood	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Louisville	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Milwaukee	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	New York	New York
United States	Novo Nordisk Clinical Trial Call Center	Raleigh	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Towson	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease activity assessed by CDAI (Crohn's disease activity index)		From baseline to week 4	No
Secondary	Number of adverse events (AEs)		From baseline to weeks 12 and 24	No
Secondary	Immunogenicity of NNC 142-0002		At week 24	No

External Links

•   Clinical Trials at Novo Nordisk