A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy - M14-431

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55449

Enrollment

Registered

2018-02-26

Start date

2018-08-02

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Crohn's disease form of Inflammatory Bowel Disease (IBD)

Interventions

All subjects receive upadacitinib or placebo once a day in the form of tablets (oral) until the end of the study or till premature discontinuation.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Confirmed diagnosis of CD for at least 3 months prior to, Baseline, - Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score., - Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader., - Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab, pegol, vedolizumab, and ustekinumab., - If female, subject must meet the contraception recommendations

Exclusion criteria

Exclusion criteria: - Participant with a current diagnosis of ulcerative colitis or indeterminate colitis., - Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX)., - Participant with the following known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, > 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study., - Participant with ostomy or ileoanal pouch, - Participant diagnosed with short gut or short bowel syndrome, - Screening laboratory and other analyses show abnormal results.

Design outcomes

Secondary

Measure	Time frame
1. Proportion of subjects with clinical remission per CDAI (CDAI	—

Primary

Measure	Time frame
Proportion of participants with clinical remission per PROs at Week 12 Proportion of participants with endoscopic response at Week 12	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)