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
Status and phase
Completed
Phase 2
Conditions
Crohn's Disease
Treatments
Drug: Placebo
Drug: ABT-494
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
Enrollment
220 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Diagnosis of Crohn's disease (CD) for at least 90 days.
- Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450.
- Subject inadequately responded to or experienced 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
- Subjects 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 recurring infections or active Tuberculosis (TB).
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
220 participants in 9 patient groups, including a placebo group
Induction Period ABT-494 Twice Daily Medium/High Dose
Active Comparator group
Description:
Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day
Treatment:
Drug: ABT-494
Extension Phase ABT-494 High Dose
Active Comparator group
Description:
Extension Phase ABT-494 High Dose orally dosed twice a day
Treatment:
Drug: ABT-494
Induction Period Placebo
Placebo Comparator group
Description:
Induction Period Placebo orally dosed twice a day
Treatment:
Drug: Placebo
Induction Period ABT-494 Low Dose
Active Comparator group
Description:
Induction Period ABT-494 Low Dose orally dosed twice a day
Treatment:
Drug: ABT-494
Induction Period ABT-494 Once Daily Medium/High Dose
Active Comparator group
Description:
Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day
Treatment:
Drug: ABT-494
Extension Phase ABT-494 Low Dose
Active Comparator group
Description:
Extension Phase ABT-494 Low Dose orally dosed twice a day
Treatment:
Drug: ABT-494
Induction Period ABT-494 High Dose
Active Comparator group
Description:
Induction Period ABT-494 High Dose orally dosed twice a day
Treatment:
Drug: ABT-494
Induction Period ABT-494 Low/Medium Dose
Active Comparator group
Description:
Induction Period ABT-494 Low/Medium Dose orally dosed twice a day
Treatment:
Drug: ABT-494
Extension Phase ABT-494 Medium Dose
Active Comparator group
Description:
Extension Phase ABT-494 Medium Dose orally dosed twice a day
Treatment:
Drug: ABT-494
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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