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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT03345849
• Date of registration: 15/11/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
• 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 Conventional and/or Biologic Therapies
• Date of first enrolment: December 7, 2017
• Target sample size: 524
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03345849
• 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 one or more conventional and/or
biologic therapies (Oral locally acting steroids, Intravenous or oral corticosteroids,
Immunosuppressants), in the opinion of the investigator.

Note: Participants who have had inadequate response or intolerance to conventional therapy
who have received prior biologic may be enrolled; however, participants must have
discontinued the biologic for reasons other than inadequate response or intolerance (e.g.,
change of insurance, well controlled disease).

- 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)

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

Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease (CD) and Achieve Clinical Remission per per Crohn's Disease Activity Index (CDAI), in Participants Taking Corticosteroids at Baseline. [Time Frame: Week 12]

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

Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs 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]

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [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]

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

Secondary ID(s)

M14-433

2017-001240-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors