Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)

• Status: Terminated
• Trial end date: 2021-07-22
• Target enrollment: 0
• Participant gender: All

Summary

The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Diagnosed with Ulcerative Colitis (UC) for at least 12 weeks prior to screening

• Screening colonoscopy for colorectal cancer conducted within the prior two years if a history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis and disease duration ≥12 years

• Evidence of disease activity at time of screening

• Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC

Exclusion Criteria:

• Diagnosis of Crohn's disease or indeterminate colitis

• History of infection with hepatitis B, human immunodeficiency virus (HIV), active hepatitis C virus (HCV) infection, or other chronic infection

• Active infections requiring systemic therapy with antibiotic, antiviral or antifungal or febrile illness within 7 days before Day -1

• History of primary or acquired immunodeficiency

• Abnormal hematologic values

• Abnormal hepatic enzyme or hepatic function values