A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis
A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.
This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.
Inclusion Criteria:
Exclusion Criteria:
global-roche-genentech-trials@gene.com888-662-6728 (U.S.)
Fortaleza, Ceará 60430-370, Brazil
Ja, São Paulo 17201-130, Brazil
So Paulo, São Paulo 01228-000, Brazil
Montreal, Quebec H1T 2M4, Canada
Guangzhou, Guangdong 510260, China
Saint-Étienne-de-Montluc, Pays de la Loire Region 42055, France
Frankfurt am Main, Hesse 60590, Germany
Hyderabad, Andhra Pradesh 500032, India
Kolkata, West Bengal 700020, India
Rome, Emilia-Romagna 00168, Italy
Kashiwa-shi, Chiba 277-0871, Japan
Fukuyama-shi, Hiroshima 720-8520, Japan
Fujidera-shi, 583-0027, Japan
Tlajomulco de Zúñiga, Jalisco 45645, Mexico
Mérida, Yucatán 97130, Mexico
Poznan, 61-731, Poland
Warsaw, 02-507, Poland
Wroc?aw, 53-149, Poland