A 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001240-35-PT

Enrollment

501

Registered

2018-03-01

Start date

2018-05-14

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Crohn's Disease (CD) MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit:

Eligibility

Sex/Gender

All

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 one or more conventional and/or biologic therapies (Oral locally acting steroids, Intravenous or oral corticosteroids, Immunosuppressants, Biologic therapies for CD), in the opinion of the investigator. Note: Non-bio-IR subjects who have received prior biologic 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 476 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: - Subject with a current diagnosis of ulcerative colitis or indeterminate colitis. - Subject not on stable doses of CD related antibiotics, oralaminosalicylates, 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 short gut or short bowel syndrome - Screening laboratory and other analyses show abnormal results.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).;Secondary Objective: To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.;Primary end point(s): Co-primary Endpoints: 1. Proportion of subjects with clinical remission per PROs at Week 12, and 2. Proportion of subjects with endoscopic response at Week 12. ;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).;Secondary Objective: To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.;Primary end point(s): Co-primary Endpoints: 1. Proportion of subjects with clinical remission per PROs at Week 12, and 2. Proportion of subjects with endoscopic response at Week 12. ;Timepoint(s) of evaluation of this end point: Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Proportion of subjects with clinical remission per CDAI (CDAI < 150) 2. Proportion of subjects with clinical remission at Week 4 3. Proportion of subjects with endoscopic remission at Week 12 4. Proportion of subjects who discontinue corticosteroid use for CD and achieve clinical remission at Week 12, in subjects taking corticosteroids for CD at Baseline 5. Change from Baseline in FACIT-F at Week 12 6. Change from Baseline in IBDQ at Week 12 7. Proportion of subjects achieving CR-100 at Week 2 8. Proportion of subjects achieving CR-100 at Week 12 9. Proportion of subjects with hospitalizations due to CD during the 12 week double-blind induction period 10. Proportion of subjects with resolution of extra-intestinal manifestation (EIM) at week 12, in subjects with EIM at Baseline ;Timepoint(s) of evaluation of this end point: 1. week 12 2. week 4 3. week 12 4. week 12 5. week 12 6. week 12 7. week 2 8. week 12 9. week 12 10. week 12	—

Measure

Time frame

Secondary end point(s): 1. Proportion of subjects with clinical remission per CDAI (CDAI < 150) 2. Proportion of subjects with clinical remission at Week 4 3. Proportion of subjects with endoscopic remission at Week 12 4. Proportion of subjects who discontinue corticosteroid use for CD and achieve clinical remission at Week 12, in subjects taking corticosteroids for CD at Baseline 5. Change from Baseline in FACIT-F at Week 12 6. Change from Baseline in IBDQ at Week 12 7. Proportion of subjects achieving CR-100 at Week 2 8. Proportion of subjects achieving CR-100 at Week 12 9. Proportion of subjects with hospitalizations due to CD during the 12 week double-blind induction period 10. Proportion of subjects with resolution of extra-intestinal manifestation (EIM) at week 12, in subjects with EIM at Baseline ;Timepoint(s) of evaluation of this end point: 1. week 12 2. week 4 3. week 12 4. week 12 5. week 12 6. week 12 7. week 2 8. week 12 9. week 12 10. week 12

—

Countries

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Egypt, Estonia, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

eu-clinical-trials@abbvie.com441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026