A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2014-003240-12-HU
• Date of registration: 25/03/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.
• Date of first enrolment: 11/05/2015
• Target sample size: 210
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003240-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 6
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Romania, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
-Male or female = 18 and = 75 years of age at Baseline
-Diagnosis of Crohn's disease (CD) for at least 90 days
-CDAI = 220 and = 450
-Subject inadequately responded to or experience intolerance to previous treatment with an immumodulator or an anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion criteria:
-Subject with ulcerative colitis (UC), collagenous colitis or indeterminate colitis
-Subject who has had surgical bowel resections in the past 6 months or is planning resection
-Subjects with an ostomy or ileoanal pouch
-Subject with symptomatic bowel stricture or abdominal or peri-anal abcess
-Subject who has short bowel syndrome
-Subject with chronic recurring infections or active Tuberculosis (TB)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's Disease
MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: ABT 494 3mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Not applicable
Current Sponsor code: ABT-494
Other descriptive name: A-1293543.74
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: ABT 494 12mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Not applicable
Current Sponsor code: ABT-494
Other descriptive name: A-1293543.74
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: week 12/16

Main Objective: The objectives of this study are to determine the efficacy and safety of multiple doses of ABT-494 versus placebo and to assess the pharmacokinetics (PK) of ABT-494 following oral administration in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to immunomodulators
or anti-TNF therapy.

Secondary Objective: Not applicable

Primary end point(s): The co-primary endpoints are:
-Proportion of subjects who achieve endoscopic remission at Week 12/16.
-Proportion of subjects who achieve clinical remission at Week 16.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Duration of the study.

Secondary end point(s): - Proportion of subjects who achieve CDAI < 150 at Week 16.
- Proportion of subjects with decrease in CDAI = 70 points from Baseline at Week 16.
- Proportion of subject who achieve remission at Week 52.

Secondary ID(s)

M13-740

2014-003240-12-BE

Source(s) of Monetary Support

AbbVie Inc.