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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
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* Drug: UTTR1147A


Participation Criteria
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Eligibility Criteria
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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: Use of prohibited concomitant therapy since enrolling in the extension study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UTTR1147A<br>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. | Drug: UTTR1147A<br>* UTTR1147A will be administered based on disease status, as described in the protocol.<br>* Other names: IL-22Fc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0) | Up to 2 years |