A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 22 February 2021
• Main ID: NCT03653026
• Date of registration: 28/08/2018
• 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 Ulcerative Colitis U-Accomplish
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: November 12, 2018
• Target sample size: 522
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03653026
• 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

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

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female participants >= 16 and <=75 years of age at Baseline

- Note: Adolescent participants at the age of 16 or 17 years old will be eligible to
participate if approved by the country or regulatory/health authorities.

Note: Adolescent participants at the age of 16 or 17 years old must weigh >=40 kilograms
and meet the definition of Tanner Stage 5 at the Screening Visit.

- Diagnosis of Ulcerative Colitis (UC) for 90 days or greater prior to Baseline,
confirmed by colonoscopy during the Screening Period, with exclusion of current
infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy
results consistent with the diagnosis of UC, in the assessment of the Investigator,
must be available.

- Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to
3.

- Demonstrated an inadequate response, loss of response, or intolerance to at lease one
of the following treatments including, oral aminosalicylates, corticosteroids,
immunosuppressants, and/or biologic therapies.

Note: Participants who have had inadequate response, loss of response to conventional
therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior
biologic for up to 1 year may be enrolled, however they must have discontinued the biologic
for reasons other than inadequate response or intolerance (e.g., change of insurance, well
controlled disease), and must meet criteria for inadequate response, loss of response, or
intolerance as defined above.

- Female Participants of childbearing potential must have a negative serum pregnancy
test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.

- If female, participant must meet the contraception recommendation criteria.

Exclusion Criteria:

- Participant with current diagnosis of Crohn's disease (CD) or diagnosis of
indeterminate colitis (IC).

- Current diagnosis of fulminant colitis and/or toxic megacolon.

- Participant with disease limited to the rectum (ulcerative proctitis) during the
Screening endoscopy.

- Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30
days prior to Baseline.

- Participant who received azathioprine or 6-mercaptopurine (6-MP) within 10 days of
Baseline.

- Received intravenous corticosteroids within 14 days prior to Screening or during the
Screening Period.

- Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g.,
tofacitinib, baricitinib, filgotinib, upadacitinib).

- Screening laboratory and other analyses show any prespecified abnormal hematologic
results.



Age minimum: 16 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Drug: Placebo

Drug: Upadacitinib (ABT-494)

Primary Outcome(s)

Percentage of Participants who Achieve Clinical Remission per Adapted Mayo Score [Time Frame: At Week 8]

Secondary Outcome(s)

Percentage of Participants Achieving Clinical Response per Adapted Mayo Score [Time Frame: At Week 8]

Percentage of Participants who Reported No Abdominal Pain [Time Frame: At Week 8]

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [Time Frame: From Baseline (Week 0) Through Week 8]

Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score [Time Frame: At Week 2]

Percentage of Participants with Endoscopic Improvement [Time Frame: At Week 8]

Percentage of Participants who Achieved Histologic Improvement [Time Frame: At Week 8]

Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [Time Frame: From Baseline (Week 0) Through Week 8]

Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement [Time Frame: At Week 8]

Percentage of Participants who Reported No Bowel Urgency [Time Frame: At Week 8]

Percentage of Participants with Endoscopic Remission [Time Frame: At Week 8]

Percentage of Participants with Mucosal Healing [Time Frame: At Week 8]

Secondary ID(s)

2016-000642-62

M14-675

Source(s) of Monetary Support

Please refer to primary and secondary sponsors