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 Conventional and/or Biologic Therapies

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 Conventional and/or Biologic Therapies - M14-433

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55413

Enrollment

Registered

2018-03-08

Start date

2019-05-13

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. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available. - Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader. - Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score. - Demonstrated an inadequate response or intolerance to one or more conventional and/or biologic therapies. Note: Participants who have received prior biologic for up to 1 year but have not failed may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), - If female, subject must meet the contraception recommendations.

Exclusion criteria

Exclusion criteria: - Subject with a current diagnosis of ulcerative colitis or indeterminate colitis. - Subject not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX). - Subject with the following known complications of CD: abscess (abdominal or peri-anal), > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum,symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study. - Subject with ostomy or ileoanal pouch - Subject diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome - Subject with surgical bowel resection within the past 3 months prior to baseline, or a history of >3 bowel resections. - Subject laboratory and other analyses show abnormal results.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)