Ulcerative colitis Digestive System
Conditions
Interventions
The protocol will be conducted as three separate studies below:
1. A 12-week double-blind induction study in adults
2. A 40-week double-blind maintenance study in adults
3. A 52-week open-label induct
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult participants: =18 years of age (and at least the legal age of consent in the jurisdiction in which the study is taking place). Adolescent participants: =12 to <18 years of age, at the time of signing the informed assent/consent. 2. Diagnosis of UC established at least 12 weeks before screening, including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC. 3. Moderately to severely active UC, defined as baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy. 4. An endoscopy subscore =2 as obtained during central review of the screening video endoscopy. 5. A participant who has had extensive UC for =8 years, or disease limited to the left side of the colon for = 10 years before the first dose of study intervention, must undergo a complete colonoscopy to assess for the presence of dysplasia within 1 year before the first dose of study intervention. Completion of the colonoscopy with dysplasia assessment is allowed during the screening period prior to the first dose of study intervention.
Exclusion criteria
Exclusion criteria: 1. Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study. 2. Presence of a stoma. 3. Presence or history of fistula. 4. Colonic resection within 24 weeks before baseline or any other intra abdominal or other major surgery performed within 12 weeks before baseline. 5. History or screening colonoscopy finding of high- or low-grade colonic mucosal dysplasia in an area of known colitis (active or historic).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Induction study (adult): Clinical remission, measured using the modified MAYO score with a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1, at Week 12 (I-12) 2. Maintenance study (adult): Clinical remission, measured using the modified MAYO score with a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1, at Week 52 (M-40) 3. Adolescent study: Clinical remission, measured using the modified MAYO score with a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1, at Week 52 (M-40) | — |
Secondary
| Measure | Time frame |
|---|---|
| Induction: 1. Clinical response at Week 12 (I-12), measured using the modified MAYO score defined as a decrease from baseline in the modified Mayo score by =30% and =2 points, with either a =1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. 2. Endoscopic improvement at Week 12 (I-12) measured by a Mayo endoscopy subscore of 0 or 1. 3. Symptomatic remission at Week 12 (I-12) measured by a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. 4. Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12 (I-12) measured as an IBDQ total score =170. 5. Histologic-endoscopic mucosal improvement at Week 12 (I-12) measured as a combination of histologic improvement (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system) and endoscopic improvement: Mayo endoscopy subscore of 0 or 1. 6. Fatigue response at Week 12 (I-12) measured as A =7-point reduction in the PROMIS-Fatigue SF-7a total score from baseline. 7. Symptomatic remission at Week 4 (I-4) measured by a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. 8. Endoscopic remission at Week 12 (I-12) measured as a Mayo endoscopy subscore of 0. 9. No bowel urgency at Week 12 (I-12) measured as a rounded weekly average of daily scores of ‘0’ for question 7 of the UC-PRO/SS. 10. No abdominal pain at Week 12 (I-12) measured as a rounded weekly average of daily scores of ‘0’ for question 8 of the UC-PRO/SS. 11. No bowel incontinence at Week 12 (I-12) measured as a rounded weekly average of daily scores of ‘0’ for question 5 of the UC-PRO/SS. Maintenance secondary outcome measures are assessed at Week 52 (M-40): 1. Endoscopic improvement measured by a Mayo endoscopy subscore of 0 or 1. 2. Symptomatic remission measured by a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. 3. 90-day corticos | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, England, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Romania, Scotland, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Outcome results
None listed