Clinical trial NCT02958865: Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
Official title: A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Mayo score
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-11-08
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ulcerative colitis for greater than/equal to 3 months.
* Moderate to severe active ulcerative colitis
* Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.

Exclusion Criteria:

* Pregnant or breastfeeding
* Clinical findings suggestive of Crohn's Disease
* History of bowel surgery within 6 months

Primary outcomes:
measure: Total Mayo Score at Week 8 (Induction Period)
timeFrame: Week 8
Secondary outcomes:
measure: Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)
timeFrame: From Week 8 up to Week 32
measure: Number of Participants With Laboratory Test Abnormalities (Chronic Period)
timeFrame: From Week 8 to Week 32
measure: Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
timeFrame: From Week 8 to Week 32
measure: Number of Participants With Abnormal Vital Signs Data (Chronic Period)
timeFrame: From Week 8 to Week 32
measure: Number of Participants With Abnormal ECG Findings (Chronic Period)
timeFrame: Week 8 to Week 32
measure: Number of Participants With Serious Infections (Chronic Period)
timeFrame: Week 8 to Week 32
measure: Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
timeFrame: Week 8 to Week 32
measure: Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
timeFrame: Week 8 to Week 32
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)
timeFrame: From Day 1 up to Week 8
measure: Number of Participants With Laboratory Test Abnormalities (Induction Period)
timeFrame: From Day 1 up to Week 8
measure: Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
timeFrame: From Day 1 up to Week 8
measure: Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
timeFrame: From Day 1 up to Week 8
measure: Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
timeFrame: From Day 1 up to Week 8
measure: Number of Participants With Abnormal Vital Signs Data (Induction Period)
timeFrame: From screening to Week 8
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)
timeFrame: From screening to Week 8
measure: Number of Participants With Serious Infections (Induction Period)
timeFrame: From Day 1 up to Week 8
measure: Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period)
timeFrame: Week 8
measure: Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period)
timeFrame: Week 8
measure: Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period)
timeFrame: Week 8
measure: Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period)
timeFrame: Week 8
measure: Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period)
timeFrame: Week 8
measure: Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period)
timeFrame: Week 8
measure: Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)
timeFrame: Baseline, Weeks 2, 4 and 8
measure: Change From Baseline in Total Mayo Score at Week 8 (Induction Period)
timeFrame: Baseline, Week 8
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
timeFrame: Week 4 and Week 8
measure: Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period)
timeFrame: Baseline, Weeks 4 and 8
measure: Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)
timeFrame: Week 4 and Week 8
measure: Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period)
timeFrame: Baseline, Week 4 and 8
measure: Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period)
timeFrame: Week 4 and Week 8
measure: Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period)
timeFrame: Week 4 and Week 8
measure: Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period)
timeFrame: Week 4 and Week 8
measure: Total Mayo Score at Week 32 (Chronic Period)
timeFrame: Week 32
measure: Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period)
timeFrame: Week 32
measure: Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period)
timeFrame: Week 32
Other outcomes:
measure: Change From Baseline in Total Mayo Score at Week 32 (Chronic Period)
timeFrame: Week 32
Locations:
city: Dothan
country: United States
facility: Dothan Surgery Center
state: Alabama
city: Dothan
country: United States
facility: Gut P.C., dba Digestive Health Specialists of the Southeast
state: Alabama
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services Inc.
state: California
city: Los Angeles
country: United States
facility: Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En-
state: California
city: San Diego
country: United States
facility: Clinical Application Laboratories, INC.
state: California
city: San Diego
country: United States
facility: San Diego Endoscopy Center
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Colorado Springs
country: United States
facility: Front Range Endoscopy Center
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Bristol
country: United States
facility: Bristol Hospital
state: Connecticut
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute
state: Connecticut
city: Plainville
country: United States
facility: Central Connecticut Endoscopy Center
state: Connecticut
city: Clearwater
country: United States
facility: West Coast Endoscopy Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Orlando
country: United States
facility: Millenia Surgery Center
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Gastroenterology, PA
state: Florida
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center
state: Maryland
city: Chevy Chase
country: United States
facility: Feldman ENT
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group Co. Inc., Chevy Chase Clinical Research
state: Maryland
city: Columbia
country: United States
facility: Cascades Endoscopy Center
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Concorde medical Group, PLLC
state: New York
city: New York
country: United States
facility: Kips Bay Endoscopy Center
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: NYU Medical Science Building
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals Endoscopy Center at Meadowmont
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center - CRU Aston
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center-Clements University Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine- Baylor Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center Endoscopy-McNair Campus
state: Texas
city: Houston
country: United States
facility: Gulf Coast Research Group
state: Texas
city: Keller
country: United States
facility: Lonestar Endoscopy, LLP
state: Texas
city: San Antonio
country: United States
facility: Sagact, Pllc.
state: Texas
city: San Antonio
country: United States
facility: Sagact, Pllc
state: Texas
city: Southlake
country: United States
facility: Lonestar Endoscopy, LLP
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Fairfax
country: United States
facility: Verity Research
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Wien
country: Austria
facility: AKH Wien Universitaetsklinik fuer Innere Medizin III
city: Sevlievo
country: Bulgaria
facility: "Medical Center-1- Sevlievo" EOOD
state: Gabrovo
city: Blagoevgrad
country: Bulgaria
facility: "MHAT-Blagoevgrad" AD
city: Dobrich
country: Bulgaria
facility: MHAT Dobrich AD
city: Haskovo
country: Bulgaria
facility: MC Hipocrat-2000 OOD
city: Lovech
country: Bulgaria
facility: MHAT Prof. Dr. Paraskev Stoyanov AD
city: Ruse
country: Bulgaria
facility: Medical Center Vitadar Consult OOD
city: Ruse
country: Bulgaria
facility: SHATPPD dr. Dimitar Gramatikov - Ruse EOOD
city: Sofia
country: Bulgaria
facility: "MC Asklepion - researches in human medicine"" EOOD
city: Sofia
country: Bulgaria
facility: "Acibadem City Clinic UMHAT" EOOD
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Slany
country: Czechia
facility: Nemocnice Slany, p.o.
city: Strakonice
country: Czechia
facility: Nemocnice Strakonice, a.s., interni oddeleni
city: Frederikssund
country: Denmark
facility: Nordsjaellands Hospital Frederikssund
city: Hilleroed
country: Denmark
facility: Nordsjaellands Hospital Hilleroed
city: Hvidovre
country: Denmark
facility: Amager og Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Tbilisi
country: Georgia
facility: Research institute of Clinical Medicine
city: Tbilisi
country: Georgia
facility: The First University Clinic of TSMU
city: Berlin
country: Germany
facility: Paian MED Research GmbH
city: Berlin
country: Germany
facility: Gastrostudien GbR
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e.V.
city: Dachau
country: Germany
facility: MVZ Dachau - Patientenzentrum
city: Dachau
country: Germany
facility: MVZ Dachau
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: Eugastro GmbH
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, II. Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I. Belgyogyaszati Gasztroenterologiai Osztaly
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Vac
country: Hungary
facility: Javorszky Odon Korhaz, Gasztroenterologia
city: Bat-Yam
country: Israel
facility: Clalit Health Services
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Tel Aviv
country: Israel
facility: Diabetes and Endocrinology Unit
city: Tel Aviv
country: Israel
facility: Migdal Hamea Clinic
city: Castellana Grotte
country: Italy
facility: IRCCS Saverio De Bellis
state: Bari
city: Bologna
country: Italy
facility: AOU Sant'Orsola-Malpighi
state: BO
city: Messina
country: Italy
facility: A.O.U. Policlinico G. Martino
state: ME
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan (MI)
city: Rho
country: Italy
facility: ASST Rhodense - Ospedale di Circolo di Rho
state: Milano (MI)
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: PI
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
state: RM
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata Udine
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Bialystok
country: Poland
facility: SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego w Bialymstoku
city: Kielce
country: Poland
facility: ETG Kielce
city: Lublin
country: Poland
facility: Gastromed Sp. z o.o.
city: Poznan
country: Poland
facility: Ai Centrum Medyczne Sp. Z O.O. Sp.K.
city: Pulawy
country: Poland
facility: KO-MED Centra Kliniczne Pulawy
city: Sopot
country: Poland
facility: ENDOSKOPIA Sp. z o. o.
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.
city: Wroclaw
country: Poland
facility: Melita Medical Sp z o.o.
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
city: Wroclaw
country: Poland
facility: Lexmedica
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A., Szpital Specjalistyczny EuroMediCare z Przychodnia
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti
state: Sector 1,
city: Timisoara
country: Romania
facility: S.C. Cabinet Particular Policlinic Algomed SRL
state: Timis
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina, Sectia de Gastroenterologie
city: Moscow
country: Russian Federation
facility: LLC "Olla-Med"
city: Moscow
country: Russian Federation
facility: FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University)
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company "Medicinsky Center SibNovoMed"
city: Novosibirsk
country: Russian Federation
facility: LLC Novosibirskiy Gastrocentr
city: Novosibirsk
country: Russian Federation
facility: Novosibirskiy Gastrocenter
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Scientific Institution
city: Omsk
country: Russian Federation
facility: FGBOU VO OmGMU Minzdrava Rossii
city: Rostov-on-Don
country: Russian Federation
facility: FSBEI HE "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation
city: Ryazan
country: Russian Federation
facility: State Budgetary Institution of Ryazan Region "Regional Clinical Hospital"
city: Saint-Petersburg
country: Russian Federation
facility: RIAT Limited Liability Company (RIAT LLC)
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution
city: Samara
country: Russian Federation
facility: Medical University REAVIZ
city: Samara
country: Russian Federation
facility: Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"
city: Samara
country: Russian Federation
facility: LLC Medical Company Hepatolog
city: Samara
country: Russian Federation
facility: LLC Medical Company Hepatolog
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zvezdara Clinic for Internal Diseases
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Bezanijska Kosa Clinic for Internal Medicine
city: Kragujevac
country: Serbia
facility: Clinical Centre of Kragujevac
city: Nis
country: Serbia
facility: Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
city: Subotica
country: Serbia
facility: General Hospital Subotica
city: Zemun, Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic"
city: Bratislava
country: Slovakia
facility: Abawi spol. s r.o
city: Nitra
country: Slovakia
facility: KM Management spol. s.r.o.
city: Sahy
country: Slovakia
facility: MUDr. Frantisek Horvath Gastroenterologia
city: Vranov nad Toplou
country: Slovakia
facility: ENDOMED, s.r.o.
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi, Ic Hastaliklari Anabilim Dali,
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi, Ibn-i-Sina Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tıp Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Kozlu Zonguldak
country: Turkey
facility: Bulent Ecevit Universitesi Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
city: Zonguldak
country: Turkey
facility: Bulent Ecevit Universitesi Tip Fakultesi
city: Chernivtsi
country: Ukraine
facility: Regional Consultative Polyclinic
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department,
city: Kharkiv
country: Ukraine
facility: MNCECCH No.2 n.a. PROF O.O. SHALIMOV of KHARKIV CITY COUNCIL
city: Kherson
country: Ukraine
facility: Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olga Tropiny"
city: Kropyvnytskyi
country: Ukraine
facility: Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #18, Proctology Department
city: Kyiv
country: Ukraine
facility: Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center
city: Lviv
country: Ukraine
facility: Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway
city: Lviv
country: Ukraine
facility: Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital"
city: Odesa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital"
city: Ternopil
country: Ukraine
facility: Municipal Institution of Ternopil regional council Ternopil University Hospital
city: Uzhgorod
country: Ukraine
facility: Municipal Institution "Uzhgorod Regional Hospital"
city: Uzhgorod
country: Ukraine
facility: Zakarpattia Regional Clinical Hospital n.a. A. Novak,
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.