A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis
- Conditions
- 1000381610017969Chronic colon inflammationform of inflammatory bowel disease (IBD)
- Registration Number
- NL-OMON49361
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 2
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
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for Study M14-675 is the proportion of subjects who<br /><br>achieve clinical remission per Adapted Mayo score (defined as SFS <= 1 and not<br /><br>greater than baseline, RBS of 0, and endoscopic sub score <= 1) at Week 8.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Proportion of subjects with endoscopic improvement at Week 8<br /><br>2. Proportion of subjects with endoscopic remission at Week 8<br /><br>3. Proportion of subjects achieving clinical response per Adapted Mayo Score at<br /><br>Week 8<br /><br>4. Proportion of subjects achieving clinical response per Partial Adapted Mayo<br /><br>score (defined as decrease from Baseline = 1 points and = 30% from Baseline,<br /><br>PLUS a decrease in RBS = 1 or an absolute RBS = 1 ) at Week 2<br /><br>5. Proportion of subjects achieving histologic-encoscopic mucosal improvement<br /><br>at Week 8<br /><br>6. Proportion of subjects who reported no bowel urgency at Week 8<br /><br>7. Proportion of subjects who reported no abdominal pain at Week 8<br /><br>8. Proportion of subjects who achieved histologic improvement at Week 8<br /><br>9. Change from Baseline in IBDQ total score at week 8<br /><br>10. Proportion of subjects with mucosal healing at Week 8<br /><br>11. Change from Baseline in FACIT-F score at week 8</p><br>