A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT03345836
• Date of registration: 15/11/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
• Date of first enrolment: November 29, 2017
• Target sample size: 625
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03345836
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

American Samoa, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of CD for at least 3 months prior to Baseline.

- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score.

- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's
disease (SES-CD) on an endoscopy confirmed by a central reader.

- Demonstrated an inadequate response or intolerance to any biologic therapy for
infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.

- If female, participant must meet the contraception recommendations.

Exclusion Criteria:

- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

- Participant not on stable doses of CD related antibiotics, oral aminosalicylates,
corticosteroids or methotrexate (MTX).

- Participant with the following ongoing known complications of CD: abscess (abdominal
or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or
any other manifestation that might require surgery while enrolled in the study.

- Participant with ostomy or ileoanal pouch.

- Participant diagnosed with conditions that could interfere with drug absorption
including but not limited to short gut or short bowel syndrome.

- Screening laboratory and other analyses show abnormal results.



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

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Other: Matching placebo for upadacitinib

Drug: upadacitinib

Primary Outcome(s)

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) [Time Frame: Week 12]

Percentage of Participants with Endoscopic Response [Time Frame: Week 12]

Secondary Outcome(s)

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: Baseline (Week 0) to Week 12]

Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease (CD) and Achieve Clinical Remission [Time Frame: Week 12]

Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIM) , in Participants with EIM at Baseline [Time Frame: Week 12]

Percentage of Participants Achieving Clinical Response 100 (CR-100) [Time Frame: Up to Week 12]

Percentage of Participants with Endoscopic Remission [Time Frame: Week 12]

Percentage of Participants with Hospitalizations due to Crohn's Disease (CD) [Time Frame: Week 12]

Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs) [Time Frame: Week 12]

Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [Time Frame: Baseline (Week 0) to Week 12]

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) [Time Frame: Week 4]

Secondary ID(s)

M14-431

2017-001226-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors