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An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2

An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease

NCT03650413•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry criteria
•Ability to comply with requirements of the study, in the investigator's judgment
•For women and men: use of highly effective contraception as defined by the protocol.

Exclusion Criteria

•Withdrawal of consent from parent study
•Discontinuation of study drug as required by the parent study protocol
•Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 or from Study GA39925 prior to Week 8
•Noncompliance in the parent study, specifically defined as missing scheduled visits or non-adherence with background medications and concomitant medications
•Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of study drug or within 18 weeks after the final dose of study drug from GA39925, whichever is longer
•Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of infection judged by the investigator to be clinically significant since enrolling in the parent study
•Use of prohibited therapies as defined in the parent study
•Abnormal laboratory values, as defined in the protocol, recorded at the last visit in the parent study
•Exclusion Criterion for Study Re-Entry:
•Use of prohibited concomitant therapy since enrolling in the extension study

Locations (57)

Carolina Digestive Diseases

Greenville, North Carolina, United States

MHAT Saint Karidad EAD

Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment Hadji Dimitar OOD

Sliven, Bulgaria

LLC ARENSIA Exploratory Medicine

Tbilisi, Georgia

Gastroenterologische Spezialpraxis-Berlin-Karlshorst

Berlin, Germany

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, Germany

Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin

Kiel, Germany

St. Marien Krankenhaus; Med. Klinik

Ludwigshafen, Germany

Iatriko Palaiou Falirou; Gastrointestinal Department

Palaió Fáliro, Greece

EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

Thessaloniki, Greece

Key Dates

Start Date

January 14, 2019

Primary Completion Date

July 12, 2022

Completion Date

July 12, 2022

Last Updated

September 29, 2023

Enrollment

143

ACTUAL participants

Conditions

Ulcerative ColitisCrohn's Disease

Interventions

UTTR1147A

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITING

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

View study

RECRUITINGPHASE2

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: September 29, 2023Data 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

An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

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

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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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