chronic bowel inflammation Ulcerative colitis
Conditions
Interventions
All subjects receive upadacitinib or placebo tablets (oral) once a day, until
end of the study or discontinuation.
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 75 years of age at Baseline. 2. Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy 3. Moderately to severely active ulcerative colitis 4. Demonstrated an inadequate response to, loss of response to, or intolerance to immunosuppressants, corticosteroids or biologic therapies 5. Negative pregnancy test for female subjects of childbearing potential
Exclusion criteria
Exclusion criteria: 1. Subject with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC). 2. Current diagnosis of fulminant colitis and/or toxic megacolon. 3. Subject with disease limited to the rectum (ulcerative proctitis) duringthe screening endoscopy. 4. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline. 5. Subject who received azathioprine or 6-mercaptopurine within 10 days of Baseline. 6. Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period. 7. Subject with previous exposure to JAK inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Substudy 1 and 2: The proportion of subjects who achieve clinical remission per Adapted Mayo score at Week 8. Substudy 3: The proportion of subjects who achieve clinical remission per Adapted Mayo score at Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Substudy 1: 1. Proportion of subjects with endoscopic improvement (subscore = 1) at Week 8 2. Proportion of subjects achieving clinical remission per Full Mayo score at Week 8 3. Proportion of subjects achieving clinical response per Adapted Mayo score at Week 8 4. Proportion of subjects achieving clinical response per Partial Mayo score at Week 2 5. Change in Full Mayo score from Baseline to Week 8 6. Proportion of subjects with endoscopic remission (subscore of 0) at Week 8 7. Proportion of subjects who achieved histologic improvement (decrease from baseline in Geboes score) at Week 8 Substudy 2: 1. Proportion of subjects with endoscopic improvement at Week 8 2. Proportion of subjects with endoscopic remission at Week 8 3. Proportion of subjects achieving clinical response per Adapted Mayo Score at Week 8 4. Proportion of subjects achieving clinical response per Partial Adapted Mayo score at Week 2 5. Proportion of subjects achieving histologic-endoscopic mucosal improvement at Week 8 6. Proportion of subjects who reported no bowel urgency at Week 8 7. Proportion of subjects who reported no abdominal pain at Week 8 8. Proportion of subjects who achieved histologic improvement at Week 9. Change from Baseline in IBDQ total score at Week 8 10. Proportion of subjects with mucosal healing at Week 8 11. Change from Baseline in FACIT-F score at Week 8 Substudy 3: 1. Proportion of subjects with endoscopic improvement 2. Proportion of subjects who maintain clinical remission per Adapted Mayo score among subjects who achieved clinical remission per Adapted Mayo score in Study M14-234 (Substudy 1 or 2) or Study M14-675 3. Proportion of subjects who achieved clinical remission at Week 52 per adapted Mayo score and were corticosteroid free for = 90 days among subjects in clinical remission in the end of the induction treatment in Study M14-234 (Substudy 1 or 2) or Study M14-675. 4. Proportion of subjects with endoscopic improvement among sub | — |
Countries
Netherlands
Outcome results
None listed