NCT01203631|CompletedPhase 2

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

Janssen Research & Development, LLC ClinicalTrials.gov

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3 other identifiers

NN8555-37972010-020836-21U1111-1116-2695

Study Type

interventional

Target

Locations

8 countries

Sites

Timeline

RegisteredSep 2010

StartedFeb 2011

CompletionMay 2013

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Feb 2011

Geographic Reach

8 countries

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

September 15, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed

5 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed

Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

September 15, 2010

Last Update Submit

July 29, 2016

Conditions

Inflammation Crohn's Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (2)

NNC 0142-0000-0002

EXPERIMENTAL

Drug: NNC 0142-0000-0002

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NNC 0142-0000-0002DRUG

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

NNC 0142-0000-0002

PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.