A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease; Inflammation
• Interventions: Drug: placebo; Drug: NNC0114-0006

• Registration Number: NCT01751152
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-17
• Study Start: 2013-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-03
• Disposition First Submitted: 2017-03-30
• Disposition First Submitted QC: 2017-03-30
• Last Update Submitted: 2017-03-30
• Disposition First Posted: 2017-03-31
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Moderately to severely active Crohn's disease, defined as a Crohn's disease activity index (CDAI) of 220-450 (both inclusive) at Visit 2 (Day 0, Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) above or equal to 10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Day -28 to -7, Screening)
• Biologic-naïve subjects or biologic-experienced for the treatment of Crohn's disease. Biologic-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of Crohn's disease due to lack of efficacy (primary or secondary efficacy failures)

Exclusion Criteria

• Body mass index (BMI) equal to or above 38.0 kg/m^2
• Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated
• History of dysplasia in the colon
• Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy
• Any history of serious recurrent infections requiring hospitalisation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC0114-0006	NNC0114-0006	-

Primary Outcome Measures

Name	Time	Method
Change in Crohn's disease activity index (CDAI)	Week 0, week 4

Secondary Outcome Measures

Name	Time	Method
Clinical remission, defined as CDAI of less than 150	At week 8
Incidence of adverse events (AEs)	Up to weeks 24 or 36
Change in the inflammatory bowel disease questionnaire (IBDQ) score	Week 0, week 4
Change in CDAI	Week 0, week 12
Incidence of anti-NNC0114-0006 antibodies	Up to weeks 24 or 36
Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores	Week 0, week 4

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Valencia, Spain