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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2021-07-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06979336

Ulcerative Colitis

RECRUITING PHASE2

A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis

NCT04209556

Ulcerative Colitis

WITHDRAWN PHASE2

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

NCT01164904

Ulcerative Colitis

TERMINATED PHASE1

A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

NCT01465763

Ulcerative Colitis

COMPLETED PHASE3

Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

NCT02958865

Ulcerative Colitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RO7049665

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

Group Type EXPERIMENTAL

RO7049665

Intervention Type DRUG

Multiple ascending doses of RO7049665 will be administered SC.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo will be administered SC.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RO7049665

Multiple ascending doses of RO7049665 will be administered SC.

Intervention Type DRUG

Placebo

Matching placebo will be administered SC.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No