Phase 3
Completed N=526
A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
Crohn's Disease
Source: ClinicalTrials.gov NCT03345849 ↗
Enrolled (actual)
526
Serious AEs
7.2%
Results posted
Nov 2022
Primary outcomePrimary: Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12 — 29.1; 49.5 percentage of participants — p=<0.0001
◆ Published Evidence
Emerging
14citations · ~7 / year
Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease.
Summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).
Linked Publications (5)
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Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease.
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Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease.
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Benefit-risk profile of upadacitinib: exploratory post hoc analysis of phase 2b/3 studies in patients with moderately to severely active ulcerative colitis or Crohn's disease.
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Long-Term Safety of Upadacitinib in Patients With Inflammatory Bowel Disease: Integrated Analysis of Phase 2/3 Studies.
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Efficacy and Safety with Upadacitinib by Baseline Corticosteroid Use in Patients with Moderately to Severely Active Crohn's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12 |
29.1; 49.5 | <0.0001 sig |
| PRIMARY Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12 |
22.2; 50.7 | <0.0001 sig |
| PRIMARY Percentage of Participants With Endoscopic Response at Week 12 |
13.1; 45.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With Endoscopic Remission at Week 12 |
7.4; 28.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12 |
15.7; 42.9 | <0.0001 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12 |
5.0; 11.3 | <0.0001 sig |
| SECONDARY Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 |
24.423; 46.265 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2 |
20.4; 32.2 | 0.0022 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12 |
37.3; 56.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With Clinical Remission Per CDAI at Week 4 |
26.7; 37.1 | 0.0071 sig |
| SECONDARY Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During the 12-Week Induction Period |
5.1; 3.7 | 0.4494 |
| SECONDARY Percentage of Participants With Resolution of Extra-Intestinal Manifestation (EIMs) at Week 12 |
20.9; 28.5 | 0.1044 |
| SECONDARY Percentage of Participants With Clinical Remission Per PROs at Week 4 |
14.8; 35.7 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per PROs at Week 12 |
12.5; 44.4 | <0.0001 sig |
Eligibility 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 or biologic therapies for CD), in the opinion of the investigator.
- Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic 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, participant must meet the contraception recommendations.
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 ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, or any other manifestation that might require surgery while enrolled in the study.
- Participant with ostomy or ileoanal pouch.
- Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
- Screening laboratory and other analyses show abnormal results.
Data sourced from ClinicalTrials.gov (NCT03345849) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.