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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT03943550

Run by

Hoffmann-La Roche

People needed

45

Starts

2019-05-13

Expected to finish

2021-07-22

Last updated by the study team

2024-02-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• The Research Institute of Clinical Medicine — Tbilisi, Georgia
• Drug Research Centre Gyogyszervizsgalo Kozpontot Kft. — Balatonfüred, Hungary
• SE ÁOK I. sz. Belgyógyászati Klinika — Budapest, Hungary
• ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location — Chisinau, Moldova
• Medical center of Yuriy Spizhenko LLC — Kapitanovka Village, KIEV Governorate, Ukraine

Full record on ClinicalTrials.gov

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