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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

NCT06979336

RecruitingPhase 2

Sponsor: Genentech, Inc.

Conditions: Ulcerative Colitis

Interventions: RO7837195, RO7837195 Matched Placebo

Countries: United States, Australia, Brazil, Canada, China, Czechia, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosis of ulcerative colitis (UC) established at least 3 months
* Moderately to severely active UC assessed by mMS
* Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC

Exclusion Criteria:

* Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
* Diagnosis of Crohn's disease or indeterminate colitis
* Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
* Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23
Locations (103)
  • Lancaster, California, United States
  • San Diego, California, United States
  • Colorado Springs, Colorado, United States
  • Kissimmee, Florida, United States
  • Chicago, Illinois, United States
  • Fresh Meadows, New York, United States
  • Monroe, North Carolina, United States
  • Salt Lake City, Utah, United States
  • South Brisbane, Queensland, Australia
  • Fortaleza, Ceará, Brazil
  • Brasília, Federal District, Brazil
  • Brasília, Federal District, Brazil
  • Belo Horizonte, Minas Gerais, Brazil
  • Curitiba, Paraná, Brazil
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Aracaju, Sergipe, Brazil
  • Ja, São Paulo, Brazil
  • Santo André, São Paulo, Brazil
  • São José do Rio Preto, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • So Paulo, São Paulo, Brazil
  • Rio de Janeiro, Brazil
  • London, Ontario, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Fuzhou, Fujian, China
  • Xiamen, Fujian, China
  • Guangzhou, Guangdong, China
  • + 73 more on CT.gov