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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

NCT03558152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2023-04-14

Study results available
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Summary

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

Conditions

Interventions

DRUG

UTTR1147A

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

DRUG

UTTR1147A Placebo

The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

DRUG

Vedolizumab

Vedolizumab will be administered IV, as specified in the prescribing information.

DRUG

Vedolizumab Placebo

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-26
Primary Completion
2021-12-15
Completion
2021-12-15
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Moldova
  • Poland
  • Russia
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03558152 on ClinicalTrials.gov