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)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC)

In brief

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

Key facts

Study ID

NCT02819635

Run by

AbbVie

People needed

1302

Starts

2016-09-26

Expected to finish

2021-12-13

Last updated by the study team

2022-06-30

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Note: Adolescent participants who are 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.

You may not qualify if…

• 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 meeting the exclusion criteria

Where it is running

• East View Medical Research, LLC /ID# 171183 — Mobile, Alabama, United States
• CB Flock Research Corporation /ID# 165980 — Mobile, Alabama, United States
• Delsol Research Management, Ll /Id# 170131 — Chandler, Arizona, United States
• Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885 — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822 — Sun City, Arizona, United States
• Adobe Clinical Research LLC /ID# 155250 — Tucson, Arizona, United States
• University of Arizona /ID# 150553 — Tucson, Arizona, United States
• Citrus Valley Gastroenterology /ID# 151914 — Covina, California, United States
• Newport Huntington Medical Group /ID# 217005 — Huntington Beach, California, United States
• UC San Diego Health System /ID# 155185 — La Jolla, California, United States
• United Medical Doctors /ID# 207464 — Los Alamitos, California, United States
• TLC Clinical Research Inc /ID# 216829 — Los Angeles, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080 — Los Angeles, California, United States
• Facey Medical Foundation /ID# 203133 — Mission Hills, California, United States
• United Medical Doctors - Murrieta /ID# 151211 — Murrieta, California, United States
• InSite Digestive Health Care - Oxnard /ID# 163414 — Oxnard, California, United States
• Inland Empire Clinical Trials, LLC /ID# 216038 — Rialto, California, United States
• San Diego Clinical Trials /ID# 212120 — San Diego, California, United States
• Medical Assoc Research Grp /ID# 169148 — San Diego, California, United States
• Univ of California San Francis /ID# 164581 — San Francisco, California, United States
• Delta Waves, Inc. /ID# 151721 — Colorado Springs, Colorado, United States
• South Denver Gastroenterology /ID# 151223 — Lone Tree, Colorado, United States
• Western States Clinical Res /ID# 158076 — Wheat Ridge, Colorado, United States
• Western Connecticut Medical Group /ID# 169210 — Danbury, Connecticut, United States
• Birmingham Gastroenterology Associates P.C /ID# 151276 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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