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

Stopped early · Phase 2

Conditions studied: Ulcerative Colitis, Crohn's Disease

In brief

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).

Key facts

Study ID

NCT03650413

Run by

Genentech, Inc.

People needed

143

Starts

2019-01-14

Expected to finish

2022-07-12

Last updated by the study team

2023-09-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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 — Padova, 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
• Carolina Digestive Diseases — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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