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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650413
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn's Disease Drug: UTTR1147A Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : December 17, 2022
Estimated Study Completion Date : December 17, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: UTTR1147A
UTTR1147A will be administered based on disease status, as described in the protocol.
Other Names:
  • RO7021610
  • RG7880
  • IL-22Fc




Primary Outcome Measures :
  1. 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 ]
  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650413


Contacts
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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

Locations
Show Show 145 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03650413    
Other Study ID Numbers: GA40209
2017-004997-32 ( EudraCT Number )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
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).


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes