Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: RO7790121: 500 mg IV at Weeks 0, 2, 6, and
10, followed by 450 mg SC every 4 weeks (Q4W) from Week 12 through Week 52
Control Intervention1: Placebo: placebo IV at Weeks 0, 2, 6,
and 10
Sponsors
F. Hoffmann- La Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Males and females of childbearing potential who are abstinent or use contraception, and refrain from donating sperm, during the treatment period and for 95 days after the final dose with Active UC confirmed by biopsy and endoscopy. Participants must have experienced intolerance, inadequate response or loss of response to at least one amongst Steroids, Immunomodulators, Aminosalicylates, Anti-TNF agents, Anti-integrins, Anti-IL12/IL23, JAK inhibitors, S1P receptor modulators. Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence. Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending more than 15cm from the anal verge. Participants with proctitis only at baseline will be capped at 10% of the total enrollment.
Exclusion criteria
Exclusion criteria: Severe UC (fulminant colitis, toxic megacolon, bowel perforation), Crohnâ??s disease, IBD unclassified, sclerosing cholangitis CMV Colitis, treatment for Clostridioides difficile, positive HIV, HbsAg, TB during screening, Apheresis. Any major surgery within 6 weeks prior to screening or a major surgery planned during the study. History of malignancy within 5 years prior to screening visit, Organ transplant, congenital immunodeficiency. Clinically significant abnormality on laboratory tests during screening - Platelet count less than 100,000/µL; Hemoglobin less than 8 g/dL; Absolute lymphocyte count less than 500/µL. Use of approved UC treatment, or any IMP, or IV corticosteroid, use of NSAID.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of RO7790121 compared with placebo in inducing remissionTimepoint: Clinical remission, defined as mMS less than or equal to 2 with SFS equal to 0 or 1, RBS equal to 0, and ES equal to 0 or 1, at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of RO7790121 compared with placebo in inducing and maintaining response. Evaluate the efficacy of RO7790121 compared with placebo in TL1A biomarker-defined subpopulations of participants. Evaluate the efficacy of RO7790121 compared with placebo in terms of UC-related symptoms and health-related quality of life.Timepoint: pmMS from baseline to Week 2. Endoscopic improvement and remission at Week 12. Histologic-endoscopic mucosal improvement less than or equal to 3.1 and ES equal to 0 or 1, at Week 12. Histologic-endoscopic remission less than 2 and ES equal to 0 or 1, at week 12. Clinical response of at least 2 points and 30% from baseline at week 12. Among TL1A biomarker subgroups, clinical remission and endoscopic improvement at week 12. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Romania, Serbia, Slovakia, Spain, Taiwan, Thailand, United Kingdom, United States of America
Contacts
Public ContactHeta Khokhani
Roche Products (India) Pvt. Ltd.
Outcome results
None listed