Clinical trial NCT03650413: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Crohn's Disease
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-28
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Plovdiv
country: Bulgaria
facility: MHAT Saint Karidad EAD
city: Sliven
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
city: Tbilisi
country: Georgia
facility: LLC ARENSIA Exploratory Medicine
city: Berlin
country: Germany
facility: Gastroenterologische Spezialpraxis-Berlin-Karlshorst
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
city: Ludwigshafen
country: Germany
facility: St. Marien Krankenhaus; Med. Klinik
city: Palaio Faliro
country: Greece
facility: Iatriko Palaiou Falirou; Gastrointestinal Department
city: Thessaloniki
country: Greece
facility: EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
city: Co Galway
country: Ireland
facility: Portiuncula Hospital, Ballinasloe
city: Roma
country: Italy
facility: Complesso Integrato Columbus
state: Lazio
city: Monza
country: Italy
facility: ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
state: Veneto
city: Chisinau
country: Moldova, Republic of
facility: ICS ARENSIA Exploratory Medicine
city: ?ód?
country: Poland
facility: SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
city: Cz?stochowa
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
city: Gda?sk
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Katowice
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Kielce
country: Poland
facility: ETG Kielce
city: Lublin
country: Poland
facility: Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
city: Piotrków Trybunalski
country: Poland
facility: Klimed Marek Klimkiewicz
city: Pozna?
country: Poland
facility: Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
city: Poznan
country: Poland
facility: Synexus - Poznan
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Wroc?aw
country: Poland
facility: Przychodnia EuroMediCare
city: Wroc?aw
country: Poland
facility: Melita Medical
city: Wroclaw
country: Poland
facility: Synexus - Wroclaw
city: Sankt-peterburg
country: Russian Federation
facility: North-West State Medical University n.a. I.I. Mechnikov
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: Saint Martyr Elizabeth City Hospital
state: Sankt Petersburg
city: Irkutsk
country: Russian Federation
facility: Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
city: Samara
country: Russian Federation
facility: Medical University Reaviz
city: Belgrade
country: Serbia
facility: KBC Dr Dragisa Misovic Dedinje
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Bezanijska kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac; Clinic Of Psychiatry
city: Vrsac
country: Serbia
facility: General Hospital Vrsac
city: Zemun
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Zrenjanin
country: Serbia
facility: General Hospital Djordje Joanovic - Zrenjanin
city: Torrejon de Ardoz
country: Spain
facility: Hospital Universitario de Torrejon
state: Madrid
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital
state: Chernihiv Governorate
city: Zhytomir
country: Ukraine
facility: Medical Centre of PE First Private Clinic
state: Crimean Regional Governmenta
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
state: Katerynoslav Governorate
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
state: Kharkiv Governorate
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Clinic Blagomed
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company ?Harmoniya krasy?
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Center Dopomoga Plus
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Medical Center of Edelweiss Medics LLC
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Synexus Affiliate - MC of LLC Medbud-Clinic
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
state: KIEV Governorate
city: Vinnytsia
country: Ukraine
facility: Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
state: Podolia Governorate
city: Uzhgorod
country: Ukraine
facility: Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
city: Zaporizhzhia
country: Ukraine
facility: Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: