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
NCT ID: NCT03650413
Last Updated: 2023-09-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
143 participants
INTERVENTIONAL
2019-01-14
2022-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
UTTR1147A
UTTR1147A will be administered based on disease status, as described in the protocol.
Interventions
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UTTR1147A
UTTR1147A will be administered based on disease status, as described in the protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Carolina Digestive Diseases
Greenville, North Carolina, United States
MHAT Saint Karidad EAD
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
Sliven, , Bulgaria
LLC ARENSIA Exploratory Medicine
Tbilisi, , Georgia
Gastroenterologische Spezialpraxis-Berlin-Karlshorst
Berlin, , Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, , Germany
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
Kiel, , Germany
St. Marien Krankenhaus; Med. Klinik
Ludwigshafen, , Germany
Iatriko Palaiou Falirou; Gastrointestinal Department
Palaió Fáliro, , Greece
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
Thessaloniki, , Greece
Portiuncula Hospital, Ballinasloe
Co Galway, , Ireland
Complesso Integrato Columbus
Rome, Lazio, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
Monza, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
Azienda Ospedaliera Di Padova
Padua, Veneto, Italy
ICS ARENSIA Exploratory Medicine
Chisinau, , Moldova
SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
?ód?, , Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
Bydgoszcz, , Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Cz?stochowa, , Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gda?sk, , Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
ETG Kielce
Kielce, , Poland
Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
Lublin, , Poland
Klimed Marek Klimkiewicz
Piotrkow Trybunalski, , Poland
Synexus - Poznan
Poznan, , Poland
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Późna, , Poland
Endoskopia Sp. z o.o.
Sopot, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Przychodnia EuroMediCare
Wroc?aw, , Poland
Melita Medical
Wroc?aw, , Poland
Synexus - Wroclaw
Wroclaw, , Poland
North-West State Medical University n.a. I.I. Mechnikov
Saint Petersburg, Sankt-Peterburg, Russia
Saint Martyr Elizabeth City Hospital
Saint Petersburg, Sankt-Peterburg, Russia
Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
Irkutsk, , Russia
Medical University Reaviz
Samara, , Russia
KBC Dr Dragisa Misovic Dedinje
Belgrade, , Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, , Serbia
Clinical Center Kragujevac; Clinic Of Psychiatry
Kragujevac, , Serbia
General Hospital Vrsac
Vršac, , Serbia
Clinical Hospital Centre Zemun
Zemun, , Serbia
General Hospital Djordje Joanovic - Zrenjanin
Zrenjanin, , Serbia
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, Spain
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, Chernihiv Governorate, Ukraine
Medical Centre of PE First Private Clinic
Zhytomyr, Crimean Regional Governmenta, Ukraine
Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
Ternopil, Katerynoslav Governorate, Ukraine
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhia, Kharkiv Governorate, Ukraine
Medical Center of LLC Medical Clinic Blagomed
Kyiv, KIEV Governorate, Ukraine
Medical Center of Limited Liability Company ?Harmoniya krasy?
Kyiv, KIEV Governorate, Ukraine
Medical Center of LLC Medical Center Dopomoga Plus
Kyiv, KIEV Governorate, Ukraine
Medical Center of Edelweiss Medics LLC
Kyiv, KIEV Governorate, Ukraine
Synexus Affiliate - MC of LLC Medbud-Clinic
Kyiv, KIEV Governorate, Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Kyiv, KIEV Governorate, Ukraine
Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
Vinnytsia, Podolia Governorate, Ukraine
Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
Uzhhorod, , Ukraine
Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
Zaporizhzhia, , Ukraine
Kings College Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-004997-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA40209
Identifier Type: -
Identifier Source: org_study_id
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