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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01203631

Enrollment

Registered

2010-09-16

Start date

2011-02-28

Completion date

2013-05-31

Last updated

2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Inflammation

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.

Interventions

DRUGNNC 0142-0000-0002

A single dose administered subcutaneously (s.c., under the skin)

DRUGPlacebo

A single dose administered subcutaneously (s.c., under the skin)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Change in disease activity assessed by CDAI (Crohn's disease activity index)	From baseline to week 4

Secondary

Measure	Time frame
Number of adverse events (AEs)	From baseline to weeks 12 and 24
Immunogenicity of NNC 142-0002	At week 24

Countries

Belgium, Canada, France, Hungary, Israel, Poland, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026