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

September 28, 2023 updated by: Genentech, Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • MHAT Saint Karidad EAD
      • Sliven, Bulgaria, 8800
        • Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
  • Georgia
      • Tbilisi, Georgia, 0112
        • LLC Arensia Exploratory Medicine
  • Germany
      • Berlin, Germany, 10318
        • Gastroenterologische Spezialpraxis-Berlin-Karlshorst
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
      • Ludwigshafen, Germany, 67067
        • St. Marien Krankenhaus; Med. Klinik
  • Greece
      • Palaio Faliro, Greece, 175 62
        • Iatriko Palaiou Falirou; Gastrointestinal Department
      • Thessaloniki, Greece, 54645
        • EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
  • Ireland
      • Co Galway, Ireland
        • Portiuncula Hospital, Ballinasloe
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Complesso Integrato Columbus
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
      • Rozzano (MI), Lombardia, Italy, 20089
        • Istituto Clinico Humanitas
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Azienda Ospedaliera di Padova
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD-2025
        • ICS ARENSIA Exploratory Medicine
  • Poland
      • ?ód?, Poland, 90-153
        • SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
      • Cz?stochowa, Poland, 42-202
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
      • Gda?sk, Poland, 80-382
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Katowice, Poland, 40-040
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
      • Kielce, Poland, 25-355
        • ETG Kielce
      • Lublin, Poland, 20-582
        • Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
      • Piotrków Trybunalski, Poland, 97-300
        • KLIMED Marek Klimkiewicz
      • Pozna?, Poland, 61-731
        • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
      • Poznan, Poland, 60-702
        • Synexus - Poznań
      • Sopot, Poland, 81-756
        • ENDOSKOPIA Sp. z o.o.
      • Warszawa, Poland, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warszawa, Poland, 00-635
        • Centrum Zdrowia MDM
      • Wroc?aw, Poland, 50-220
        • Przychodnia EuroMediCare
      • Wroc?aw, Poland, 50-449
        • Melita Medical
      • Wroclaw, Poland, 50-088
        • Synexus - Wroclaw
  • Russian Federation
      • Irkutsk, Russian Federation, 664033
        • Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
      • Samara, Russian Federation, 443011
        • Medical University Reaviz
    • Sankt Petersburg
      • Sankt-peterburg, Sankt Petersburg, Russian Federation, 195257
        • Saint Martyr Elizabeth City Hospital
      • Sankt-peterburg, Sankt Petersburg, Russian Federation, 191015
        • North-West State Medical University n.a. I.I. Mechnikov
  • Serbia
      • Belgrade, Serbia, 11000
        • KBC Dr Dragisa Misovic Dedinje
      • Belgrade, Serbia, 11080
        • University Hospital Medical Center Bezanijska kosa
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac; Clinic Of Psychiatry
      • Vrsac, Serbia, 26300
        • General Hospital Vrsac
      • Zemun, Serbia, 11080
        • Clinical Hospital Centre Zemun
      • Zrenjanin, Serbia, 23000
        • General Hospital Djordje Joanovic - Zrenjanin
  • Spain
    • Madrid
      • Torrejon de Ardoz, Madrid, Spain, 28850
        • Hospital Universitario de Torrejon
  • Ukraine
      • Uzhgorod, Ukraine, 88000
        • Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
      • Zaporizhzhia, Ukraine, 69035
        • Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
    • Chernihiv Governorate
      • Chernivtsi, Chernihiv Governorate, Ukraine, 58005
        • Regional Municipal Institution Chernivtsi Regional Clinical Hospital
    • Crimean Regional Governmenta
      • Zhytomir, Crimean Regional Governmenta, Ukraine, 10008
        • Medical Centre of PE First Private Clinic
    • KIEV Governorate
      • Kyiv, KIEV Governorate, Ukraine, 2091
        • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
      • Kyiv, KIEV Governorate, Ukraine, 01001
        • Medical Center of LLC Medical Clinic Blagomed
      • Kyiv, KIEV Governorate, Ukraine, 02000
        • Medical Center of LLC Medical Center Dopomoga Plus
      • Kyiv, KIEV Governorate, Ukraine, 02002
        • Medical Center of Edelweiss Medics LLC
      • Kyiv, KIEV Governorate, Ukraine, 03037
        • Synexus Affiliate - MC of LLC Medbud-Clinic
      • Kyiv, KIEV Governorate, Ukraine, 01135
        • Medical Center of Limited Liability Company ?Harmoniya krasy?
    • Katerynoslav Governorate
      • Ternopil, Katerynoslav Governorate, Ukraine, 46002
        • Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
    • Kharkiv Governorate
      • Zaporizhzhia, Kharkiv Governorate, Ukraine, 69600
        • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
    • Podolia Governorate
      • Vinnytsia, Podolia Governorate, Ukraine, 21029
        • Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
  • United Kingdom
      • London, United Kingdom, SW9 8RR
        • Kings College Hospital
  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Carolina Digestive Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • RG7880
  • RO7021610
  • IL-22Fc
  • Efmarodocokin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 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)
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

July 12, 2022

Study Completion (Actual)

July 12, 2022

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA40209
  • 2017-004997-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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