search
Back to results

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

Primary Purpose

Ulcerative Colitis, Crohn's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UTTR1147A
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carolina Digestive Diseases
  • MHAT Saint Karidad EAD
  • Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
  • LLC ARENSIA Exploratory Medicine
  • Gastroenterologische Spezialpraxis-Berlin-Karlshorst
  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
  • Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
  • St. Marien Krankenhaus; Med. Klinik
  • Iatriko Palaiou Falirou; Gastrointestinal Department
  • EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
  • Portiuncula Hospital, Ballinasloe
  • Complesso Integrato Columbus
  • ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
  • Istituto Clinico Humanitas
  • Azienda Ospedaliera Di Padova
  • ICS ARENSIA Exploratory Medicine
  • SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
  • ETG Kielce
  • Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
  • Klimed Marek Klimkiewicz
  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
  • Synexus - Poznan
  • Endoskopia Sp. z o.o.
  • Centrum Zdrowia MDM
  • WIP Warsaw IBD Point Profesor Kierkus
  • Przychodnia EuroMediCare
  • Melita Medical
  • Synexus - Wroclaw
  • North-West State Medical University n.a. I.I. Mechnikov
  • Saint Martyr Elizabeth City Hospital
  • Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
  • Medical University Reaviz
  • KBC Dr Dragisa Misovic Dedinje
  • University Hospital Medical Center Bezanijska kosa
  • Clinical Center Kragujevac; Clinic Of Psychiatry
  • General Hospital Vrsac
  • Clinical Hospital Centre Zemun
  • General Hospital Djordje Joanovic - Zrenjanin
  • Hospital Universitario de Torrejon
  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital
  • Medical Centre of PE First Private Clinic
  • Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
  • Medical Center of LLC Medical Clinic Blagomed
  • Medical Center of Limited Liability Company ?Harmoniya krasy?
  • Medical Center of LLC Medical Center Dopomoga Plus
  • Medical Center of Edelweiss Medics LLC
  • Synexus Affiliate - MC of LLC Medbud-Clinic
  • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
  • Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
  • Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
  • Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
  • Kings College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UTTR1147A

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
August 16, 2018
Last Updated
September 28, 2023
Sponsor
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03650413
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early by the Sponsor based on the interim analysis of Study GA39925 (NCT03558152) that showed low efficacy of UTTR1147A in ulcerative colitis. Development of the drug in this indication has been terminated.
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UTTR1147A
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
UTTR1147A
Other Intervention Name(s)
Efmarodocokin alfa, RO7021610, RG7880, IL-22Fc
Intervention Description
UTTR1147A will be administered based on disease status, as described in the protocol.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Carolina Digestive Diseases
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
MHAT Saint Karidad EAD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
LLC ARENSIA Exploratory Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Gastroenterologische Spezialpraxis-Berlin-Karlshorst
City
Berlin
ZIP/Postal Code
10318
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
St. Marien Krankenhaus; Med. Klinik
City
Ludwigshafen
ZIP/Postal Code
67067
Country
Germany
Facility Name
Iatriko Palaiou Falirou; Gastrointestinal Department
City
Palaio Faliro
ZIP/Postal Code
175 62
Country
Greece
Facility Name
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Portiuncula Hospital, Ballinasloe
City
Co Galway
Country
Ireland
Facility Name
Complesso Integrato Columbus
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
ICS ARENSIA Exploratory Medicine
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
City
?ód?
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
City
Cz?stochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gda?sk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
ETG Kielce
City
Kielce
ZIP/Postal Code
25-355
Country
Poland
Facility Name
Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Klimed Marek Klimkiewicz
City
Piotrków Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
City
Pozna?
ZIP/Postal Code
61-731
Country
Poland
Facility Name
Synexus - Poznan
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Przychodnia EuroMediCare
City
Wroc?aw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Melita Medical
City
Wroc?aw
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Synexus - Wroclaw
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
North-West State Medical University n.a. I.I. Mechnikov
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Saint Martyr Elizabeth City Hospital
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
City
Irkutsk
ZIP/Postal Code
664033
Country
Russian Federation
Facility Name
Medical University Reaviz
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
KBC Dr Dragisa Misovic Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Hospital Medical Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac; Clinic Of Psychiatry
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
General Hospital Vrsac
City
Vrsac
ZIP/Postal Code
26300
Country
Serbia
Facility Name
Clinical Hospital Centre Zemun
City
Zemun
ZIP/Postal Code
11080
Country
Serbia
Facility Name
General Hospital Djordje Joanovic - Zrenjanin
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Hospital Universitario de Torrejon
City
Torrejon de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
City
Chernivtsi
State/Province
Chernihiv Governorate
ZIP/Postal Code
58005
Country
Ukraine
Facility Name
Medical Centre of PE First Private Clinic
City
Zhytomir
State/Province
Crimean Regional Governmenta
ZIP/Postal Code
10008
Country
Ukraine
Facility Name
Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
City
Ternopil
State/Province
Katerynoslav Governorate
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
City
Zaporizhzhia
State/Province
Kharkiv Governorate
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Medical Center of LLC Medical Clinic Blagomed
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
01001
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company ?Harmoniya krasy?
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Medical Center of LLC Medical Center Dopomoga Plus
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02000
Country
Ukraine
Facility Name
Medical Center of Edelweiss Medics LLC
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02002
Country
Ukraine
Facility Name
Synexus Affiliate - MC of LLC Medbud-Clinic
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
City
Vinnytsia
State/Province
Podolia Governorate
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SW9 8RR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

We'll reach out to this number within 24 hrs