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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

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ClinicalTrials.gov Identifier: NCT03650413
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE August 28, 2018
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE January 14, 2019
Estimated Primary Completion Date December 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • 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) [ Time Frame: Up to 1 year ]
  • Number of Participants with Adverse Events of Clinically Significant Changes From Baseline in Targeted Vital Signs [ Time Frame: From Baseline (Day 1) to last study visit (up to 1 year) ]
    Targeted vital signs will include measurements of respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature. Here, we will report the percentage of participants who experienced adverse events of clinically significant changes from baseline in targeted vital signs, as judged by the investigator. The incidence for each adverse event will be reported in the adverse events section.
  • Number of Participants with Adverse Events of Clinically Significant Changes From Baseline in Physical Examination Findings [ Time Frame: From Baseline (Day 1) to last study visit (up to 1 year) ]
    A complete physical examination will be performed at baseline, followed by limited, symptom-directed physical examinations, as described in the protocol. Here, we will report the percentage of participants who experienced adverse events of clinically significant changes from baseline in physical examination findings, as judged by the investigator. The incidence for each adverse event will be reported in the adverse events section.
  • Number of Participants with Adverse Events of Clinically Significant Changes From Baseline in Laboratory Test Results [ Time Frame: From Baseline (Day 1) to last study visit (up to 1 year) ]
    Laboratory tests will include urinalysis, hematology, and serum chemistry. Here, we will report the percentage of participants who experienced adverse events of clinically significant changes from baseline in laboratory test results, as judged by the investigator. The incidence for each adverse event will be reported in the adverse events section.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • Percentage of Participants with Severe Adverse Events (Grade ≥3), Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0) [ Time Frame: Up to 1 year ]
  • Percentage of Participants with Adverse Events of Clinically Significant Changes From Baseline in Targeted Vital Signs [ Time Frame: From Baseline (Day 1) to last study visit (up to 1 year) ]
    Targeted vital signs will include measurements of respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature. Here, we will report the percentage of participants who experienced adverse events of clinically significant changes from baseline in targeted vital signs, as judged by the investigator. The incidence for each adverse event will be reported in the adverse events section.
  • Percentage of Participants with Adverse Events of Clinically Significant Changes From Baseline in Physical Examination Findings [ Time Frame: From Baseline (Day 1) to last study visit (up to 1 year) ]
    A complete physical examination will be performed at baseline, followed by limited, symptom-directed physical examinations, as described in the protocol. Here, we will report the percentage of participants who experienced adverse events of clinically significant changes from baseline in physical examination findings, as judged by the investigator. The incidence for each adverse event will be reported in the adverse events section.
  • Percentage of Participants with Adverse Events of Clinically Significant Changes From Baseline in Laboratory Test Results [ Time Frame: From Baseline (Day 1) to last study visit (up to 1 year) ]
    Laboratory tests will include urinalysis, hematology, and serum chemistry. Here, we will report the percentage of participants who experienced adverse events of clinically significant changes from baseline in laboratory test results, as judged by the investigator. The incidence for each adverse event will be reported in the adverse events section.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Phase Ib Study GA29469 and Phase II Study GA39925 (parent studies).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Crohn's Disease
Intervention  ICMJE Drug: UTTR1147A
UTTR1147A will be administered based on disease status, as described in the protocol.
Other Names:
  • RO7021610
  • RG7880
  • IL-22Fc
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: UTTR1147A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2018)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 17, 2022
Estimated Primary Completion Date December 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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 value recorded at the last visit in the parent study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GA40209 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Bulgaria,   Georgia,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Moldova, Republic of,   Netherlands,   Poland,   Russian Federation,   Serbia,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries China,   France
 
Administrative Information
NCT Number  ICMJE NCT03650413
Other Study ID Numbers  ICMJE GA40209
2017-004997-32 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP