A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT02819635
• Date of registration: 28/06/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: September 26, 2016
• Target sample size: 844
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02819635
• 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:

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 authority. If approval has not
been granted, only participants >= 18 years old will be enrolled.

Adolescents must weigh >= 40 kilograms and meet the definition of Tanner Stage 5 at
Screening Visit.

- Diagnosis of ulcerative colitis 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 ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic
sub score of 2 to 3 (confirmed by central reader).

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

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 to aminosalicylates, corticosteroids, and/or immunosuppressants as defined
above.

- If female, participant must meet the criteria for Contraception Recommendations.

- 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
prior to study drug dosing.

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 on azathioprine or 6-mercaptopurine 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 abnormal results.



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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Drug: Updacitinib (ABT-494)

Drug: Placebo

Primary Outcome(s)

Substudy 1/Substudy 2: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score [Time Frame: At Week 8]

Substudy 3: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score [Time Frame: At Week 52]

Secondary Outcome(s)

Substudy 3: Percentage Of Participants Who Maintain Clinical Response Per Adapted Mayo Score [Time Frame: At Week 52]

Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement [Time Frame: At Week 8]

Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement [Time Frame: At Week 8]

Substudy 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire Score [Time Frame: Baseline (Week 0) to Week 8]

Substudy 2: Percentage Of Participants With Endoscopic Remission [Time Frame: At Week 8]

Substudy 2: Percentage Of Participants With Mucosal Healing [Time Frame: At Week 8]

Substudy 3: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [Time Frame: Baseline (Week 0) to Week 52]

Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score [Time Frame: At Week 8]

Substudy 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [Time Frame: Baseline (Week 0) to Week 8]

Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement [Time Frame: At Week 8]

Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain [Time Frame: At Week 8]

Substudy 1: Percentage Of Participants With Endoscopic Improvement [Time Frame: At Week 8]

Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score [Time Frame: At Week 8]

Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo score And Were Corticosteroid Free = 90 days [Time Frame: At Week 52]

Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score [Time Frame: At Week 2]

Substudy 2: Percentage Of Participants Who Report No Bowel Urgency [Time Frame: At Week 8]

Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement [Time Frame: At Week 52]

Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency [Time Frame: At Week 52]

Substudy 3: Percentage Of Participants Who Maintain Clinical Remission Per Adapted Mayo Score Among Participants Who Received Clinical Remission Per Adapted Mayo Score in Study M14-234 (Substudy 1 or 2) Or M14-675 [Time Frame: At Week 52]

Substudy 3: Percentage Of Participants With Endoscopic Improvement Among Participants Who Had Endoscopic Improvement In Study M14-234 (Substudy 1 or 2) Or Study M14-675 [Time Frame: At Week 52]

Substudy 1: Percentage Of Participants With Endoscopic Remission [Time Frame: At Week 8]

Substudy 2: Percentage Of Participants With Endoscopic Improvement [Time Frame: At Week 8]

Substudy 1: Change in Full Mayo Score [Time Frame: Baseline (Week 0) to Week 8]

Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain [Time Frame: At Week 52]

Substudy 3: Percentage Of Participants With Endoscopic Improvement [Time Frame: At Week 52]

Substudy 3: Percentage Of Participants With Endoscopic Remission [Time Frame: At Week 52]

Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score [Time Frame: At Week 8]

Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score [Time Frame: At Week 2]

Substudy 3: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [Time Frame: Baseline (Week 0) to Week 52]

Substudy 3: Percentage Of Participants With Mucosal Healing [Time Frame: At Week 52]

Secondary ID(s)

M14-234

2016-000641-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors