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

TERMINATEDPHASE1

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

A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis

NCT03943550•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

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

Locations (6)

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

Key Dates

Start Date

May 13, 2019

Primary Completion Date

July 22, 2021

Completion Date

July 22, 2021

Last Updated

February 15, 2024

Enrollment

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

RO7049665

DRUG

Placebo

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

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RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects