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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC)

In brief

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Key facts

Study ID

NCT03653026

Run by

AbbVie

People needed

522

Starts

2018-12-06

Expected to finish

2021-01-14

Last updated by the study team

2022-03-02

Who can join

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

You may qualify if…

• 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.

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 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.

Where it is running

• CB Flock Research Corporation /ID# 206094 — Mobile, Alabama, United States
• Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030 — Sun City, Arizona, United States
• Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887 — Tempe, Arizona, United States
• University of Arizona /ID# 208856 — Tucson, Arizona, United States
• Citrus Valley Gastroenterology /ID# 205627 — Covina, California, United States
• Care Access Research /ID# 217003 — Huntington Beach, California, United States
• Moore UC San Diego Cancer Center /ID# 204919 — La Jolla, California, United States
• United Medical Doctors /ID# 207867 — Los Alamitos, California, United States
• TLC Clinical Research Inc /ID# 216831 — Los Angeles, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314 — Los Angeles, California, United States
• Facey Medical Foundation /ID# 205301 — Mission Hills, California, United States
• United Medical Doctors - Murrieta /ID# 205313 — Murrieta, California, United States
• InSite Digestive Health Care - Oxnard /ID# 205628 — Oxnard, California, United States
• Inland Empire Clinical Trials, LLC /ID# 216164 — Rialto, California, United States
• San Diego Clinical Trials /ID# 212122 — San Diego, California, United States
• Medical Assoc Research Grp /ID# 205626 — San Diego, California, United States
• Delta Waves, Inc. /ID# 206170 — Colorado Springs, Colorado, United States
• Western States Clinical Res /ID# 206091 — Wheat Ridge, Colorado, United States
• Western Connecticut Medical Group /ID# 208290 — Danbury, Connecticut, United States
• Gastroenterology Center of CT /ID# 208291 — Hamden, Connecticut, United States
• Gastro Florida /ID# 206174 — Clearwater, Florida, United States
• Universal Axon Clinical Research /ID# 213462 — Doral, Florida, United States
• Palmetto Research, LLC /ID# 208293 — Hialeah, Florida, United States
• Nature Coast Clinical Research - Inverness /ID# 206087 — Inverness, Florida, United States
• East View Medical Research, LLC /ID# 216933 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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