A Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis

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 [M14-675]

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224070

Enrollment

Registered

2018-09-28

Start date

2018-12-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

investigational material(s) Generic name etc : ABT-494 INN of investigational material : upadacitinib Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 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. - 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

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
safety efficacy confirmatory pharmacogenomics -	—

Secondary

Measure	Time frame
exploratory pharmacokinetics pharmacodynamics pharmacogenomics -	—

Countries

-, Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026