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

Roche

Status and phase: Terminated; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: RO7049665; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03943550

2017-004599-74 (EudraCT Number)

WP40161

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

RO7049665

Experimental group

Description:

Participants will receive a subcutaneous (SC) dose of RO7049665 every 2 weeks for 4 doses.

Treatment:

Drug: RO7049665

Placebo

Placebo Comparator group

Description:

Participants will receive a SC dose of matching placebo every 2 weeks for 4 doses.

Treatment:

Drug: Placebo