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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03650413
• Other study ID #: GA40209
• Secondary ID: 2017-004997-32
• Status: Terminated
• Phase: Phase 2
• Start date: January 14, 2019
• Est. completion date: July 12, 2022

Study information

• Verified date: September 2023
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 143
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• UTTR1147A
UTTR1147A will be administered based on disease status, as described in the protocol.

Locations

Country	Name	City	State
Bulgaria	MHAT Saint Karidad EAD	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment Hadji Dimitar OOD	Sliven
Georgia	LLC ARENSIA Exploratory Medicine	Tbilisi
Germany	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
Greece	Iatriko Palaiou Falirou; Gastrointestinal Department	Palaio Faliro
Greece	EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department	Thessaloniki
Ireland	Portiuncula Hospital, Ballinasloe	Co Galway
Italy	ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore	Monza	Lombardia
Italy	Azienda Ospedaliera Di Padova	Padova	Veneto
Italy	Complesso Integrato Columbus	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano (MI)	Lombardia
Moldova, Republic of	ICS ARENSIA Exploratory Medicine	Chisinau
Poland	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	Piotrków Trybunalski
Poland	Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa	Pozna?
Poland	Synexus - Poznan	Poznan
Poland	Endoskopia Sp. z o.o.	Sopot
Poland	Centrum Zdrowia MDM	Warszawa
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	Melita Medical	Wroc?aw
Poland	Przychodnia EuroMediCare	Wroc?aw
Poland	Synexus - Wroclaw	Wroclaw
Russian Federation	Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science	Irkutsk
Russian Federation	Medical University Reaviz	Samara
Russian Federation	North-West State Medical University n.a. I.I. Mechnikov	Sankt-peterburg	Sankt Petersburg
Russian Federation	Saint Martyr Elizabeth City Hospital	Sankt-peterburg	Sankt Petersburg
Serbia	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	Vrsac
Serbia	Clinical Hospital Centre Zemun	Zemun
Serbia	General Hospital Djordje Joanovic - Zrenjanin	Zrenjanin
Spain	Hospital Universitario de Torrejon	Torrejon de Ardoz	Madrid
Ukraine	Regional Municipal Institution Chernivtsi Regional Clinical Hospital	Chernivtsi	Chernihiv Governorate
Ukraine	Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"	Kyiv	KIEV Governorate
Ukraine	Medical Center of Edelweiss Medics LLC	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 LLC Medical Clinic Blagomed	Kyiv	KIEV Governorate
Ukraine	Synexus Affiliate - MC of LLC Medbud-Clinic	Kyiv	KIEV Governorate
Ukraine	Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology	Ternopil	Katerynoslav Governorate
Ukraine	Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department	Uzhgorod
Ukraine	Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov	Vinnytsia	Podolia Governorate
Ukraine	Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3	Zaporizhzhia
Ukraine	Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council	Zaporizhzhia	Kharkiv Governorate
Ukraine	Medical Centre of PE First Private Clinic	Zhytomir	Crimean Regional Governmenta
United Kingdom	Kings College Hospital	London
United States	Carolina Digestive Diseases	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Georgia,  Germany,  Greece,  Ireland,  Italy,  Moldova, Republic of,  Poland,  Russian Federation,  Serbia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to 2 years