Chronic colon inflammation form of inflammatory bowel disease (IBD)
Conditions
Interventions
None listed
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between 16 and 75 years of age at Baseline. - Adolescent subjects at the age of 16 and 17 years old will be enrolled if approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects = 18 years old will be enrolled. - Adolescent subjects at the age of 16 and 17 years old must weigh = 40 kg and meet the definition of Tanner Stage 5 (refer to Appendix J) at the screening Visit. 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) during the 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 |
|---|---|
| The primary endpoint for Study M14-675 is the proportion of subjects who achieve clinical remission per Adapted Mayo score (defined as SFS | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 (defined as decrease from Baseline = 1 points and = 30% from Baseline, PLUS a decrease in RBS = 1 or an absolute RBS = 1 ) at Week 2 5. Proportion of subjects achieving histologic-encoscopic 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 8 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 | — |
Countries
Netherlands
Outcome results
None listed