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: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT02365649
• Date of registration: 16/02/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• 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: March 17, 2015
• Target sample size: 220
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02365649
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of Crohn's disease (CD) for at least 90 days.

2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
equal to 450.

3. Subject inadequately responded to or experience intolerance to previous treatment with
immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or
anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

Exclusion Criteria:

1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.

2. Subject who has had surgical bowel resections in the past 6 months or is planning
resection.

3. Subjects with an ostomy or ileoanal pouch.

4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

5. Subject who has short bowel syndrome.

6. Subject with recurring infections or active Tuberculosis (TB).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: ABT-494

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Who Achieve Clinical Remission at Week 16 [Time Frame: Week 16]

Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 [Time Frame: Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)]

Secondary Outcome(s)

Percentage of Participants With a Decrease in CDAI = 70 Points From Baseline at Week 16 [Time Frame: Week 16]

Percentage of Subjects Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16 [Time Frame: Week 16]

Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16 [Time Frame: Week 16]

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase [Time Frame: Baseline, Week 8, Week 16]

Percentage of Participants Who Achieve Clinical Remission at Week 12 [Time Frame: Week 12]

Change from Baseline in Fecal Calprotectin Level Over Time During the Induction Phase [Time Frame: Baseline, Week 4, Week 16]

Percentage of Participants Who Achieve Remission at Week 16 [Time Frame: Week 16]

Percentage of Subjects Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16 [Time Frame: Up to Week 16. (At Baseline, patients were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)]

Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16 [Time Frame: Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)]

Percentage of Participants With Endoscopic Response at Week 12/16 [Time Frame: Up to Week 16. (At Baseline, patients were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)]

Percentage of Participants Who Achieve Clinical Response at Week 16 [Time Frame: Week 16]

Percentage of Subjects With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16 [Time Frame: Week 16]

Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) at Week 16 [Time Frame: Baseline, Week 16]

Percentage of Participants Who Achieve Response at Week 16 [Time Frame: Week 16]

Percentage of Subjects Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16 [Time Frame: Week 16]

Percentage of Subjects With an Average Daily Stool Frequency = 2.5 AND Average Daily Abdominal Pain = 2.0 at Baseline Who Achieve Clinical Remission at Week 16 [Time Frame: Week 16]

Secondary ID(s)

M13-740

2014-003240-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors