Clinical trial NCT03558152: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Official title: A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of UC
* Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
* Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor \[TNF\] inhibitors \[maximum of 2 prior TNF inhibitors\]) and/or corticosteroid treatment
* Use of highly effective contraception as defined by the protocol

Exclusion Criteria:

* History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
* History of cancer as defined by the protocol
* Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
* Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
* Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
* Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
* Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
* History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
* Prior treatment with UTTR1147A
* Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
* Prior treatment with rituximab
* Use of prohibited therapies, as defined by the protocol, prior to randomization
* Congenital or acquired immune deficiency
* Evidence or treatment of infections or history of infections, as defined by the protocol

Primary outcomes:
measure: Percentage of Participants With Clinical Remission at Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Remission
timeFrame: At Weeks 8 and 30
measure: Maximum Serum Concentration (Cmax) of UTTR1147A
timeFrame: Days 1 - 29, Visit: Day 57
measure: Minimum Serum Concentration (Cmin) of UTTR1147A
timeFrame: Days 1 - 29, Visit: Day 57
measure: Percentage of Participants With Clinical Response at Week 8
timeFrame: At Week 8
measure: Percentage of Participants With Clinical Response at Week 30
timeFrame: At Week 30
measure: Percentage of Participants With Endoscopic Healing at Week 8
timeFrame: At Week 8
measure: Percentage of Participants With Endoscopic Healing at Week 30
timeFrame: At Week 30
measure: Percentage of Participants With Endoscopic Remission at Week 8
timeFrame: At Week 8
measure: Percentage of Participants With Endoscopic Remission at Week 30
timeFrame: At Week 30
measure: Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
timeFrame: At Week 8
measure: Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
timeFrame: At Week 30
measure: Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
timeFrame: At Week 8
measure: Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
timeFrame: At Week 30
measure: Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
timeFrame: At Week 8
measure: Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30
timeFrame: At Week 30
measure: Percentage of Participants With Adverse Events
timeFrame: Up to 30 weeks
measure: Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration
timeFrame: Baseline up to 30
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine; Gastroenterology Division
state: Utah
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: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Ludwigshafen
country: Germany
facility: St. Marien Krankenhaus; Med. Klinik
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Klinik für Innere Medizin II
city: Palaio Faliro
country: Greece
facility: Iatriko Palaiou Falirou; Gastrointestinal Department
city: Thessaloniki
country: Greece
facility: EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ
city: Co Galway
country: Ireland
facility: Portiuncula Hospital, Ballinasloe
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center; Bait Vagan
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico Di Roma
state: Lazio
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: Synexus Polska Sp. z o.o. Oddzial w Czestochowie
city: Gda?sk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Katowice
country: Poland
facility: Synexus - Katowice
city: Katowice
country: Poland
facility: Economicus - NZOZ ALL-MEDICUS; Zaklad Gastroenterologii
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: Synexus Polska Sp. z o.o. Oddzial w Poznaniu
city: Pozna?
country: Poland
facility: Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Toru?
country: Poland
facility: Gastromed Kopon Zmudzinski i
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Jaroslaw Kierkus Prywatna Prakyka Lekarska
city: Wroc?aw
country: Poland
facility: Przychodnia EuroMediCare
city: Wroc?aw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Wroc?aw
country: Poland
facility: Melita Medical
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: Rostov-na-Donu
country: Russian Federation
facility: Rostov State Medical University; Cardiorheumatology Department
city: Samara
country: Russian Federation
facility: Medical University Reaviz
city: St. Petersburg
country: Russian Federation
facility: North-West State Medical University n.a. I.I. Mechnikov
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
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: Las Palmas de Gran Canaria
country: Spain
facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo
state: LAS Palmas
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; Gastroenterology department
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: Vinnytsia
country: Ukraine
facility: City Clinical Hospital #1; Department of Gastroenterology
state: Kharkiv Governorate
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
state: Kharkiv Governorate
city: Dnipro
country: Ukraine
facility: ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
state: KIEV Governorate
city: Kropyvnytskyi
country: Ukraine
facility: Treatment and Diagnostic Center of LLC MRT Elit
state: KIEV 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: Zaporizhzhia
country: Ukraine
facility: Medical Center of LLC Diaservis
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: Dnipr
country: Ukraine
facility: Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology
state: Polissya Okruha
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: