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

Phase 2

Terminated

Brief 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).

Recruitment & Eligibility

Inclusion Criteria

Inclusion Criteria for Study Entry:

Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry criteria

Inclusion Criteria for Study Entry and Study Re-Entry:

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

Exclusion Criteria for Study Entry:

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

Exclusion Criteria for Study Entry and Study Re-Entry:

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:

Arm && Interventions

Group	Intervention	Description
UTTR1147A	UTTR1147A	All participants will have the opportunity to receive treatment with UTTR1147A until clinical remission is achieved. Participants will either receive treatment with UTTR1147A or undergo observation depending on disease status, as described in the protocol.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Up to 2 years	Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0)

Secondary Outcome Measures

Name	Time	Method

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
🇬🇷
Palaio Faliro, Greece
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
🇬🇷
Thessaloniki, Greece
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Carolina Digestive Diseases
🇺🇸Greenville, North Carolina, United States