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. Moderately to severely active UC (mMS of 5-9), including an ES of >=2. Patients at risk of colon cancer must have had surveillance colonoscopy within two years prior to baseline; if not, they must be willing to have a colonoscopy at screening
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 |
|---|---|
| - To evaluate efficacy of RO7790121 compared with placebo in inducing remission. - To evaluate the efficacy of RO7790121 compared with placebo in maintaining remission. Timepoint: - Clinical remission defined as Mms less than equal to 2 with SFS equal to 0 or 1, RBS equal to 0, and ES equal to 0 or 1, at week 12. - Clinical remission, as defined above, at Week 52. | — |
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: Endoscopic improvement and remission. Maintenance of remission, at both Weeks 12 and 52. Corticosteroid-free remission, at Week 52 and no use of corticosteroids for UC at least 8 weeks prior to Week 52. Endoscopic improvement and remission at Week 52. Histologic-endoscopic mucosal improvement and remission at Week 52. Clinical remission at Week 12 and Week 52. Endoscopic improvement at Week 12 and week 52. Bowel urgency and Abdominal pain from baseline through Week 52. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Hungary, India, Israel, Italy, Japan, 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