Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

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

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: PF-06651600 or Placebo; Drug: PF-06700841 or Placebo; Drug: PF-06651600; Drug: PF-06700841

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
    • AKH Wien Universitaetsklinik fuer Innere Medizin III
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • "MHAT-Blagoevgrad" AD
  • Dobrich, Bulgaria, 9300
    • MHAT Dobrich AD
  • Haskovo, Bulgaria, 6300
    • MC Hipocrat-2000 OOD
  • Lovech, Bulgaria, 5500
    • MHAT Prof. Dr. Paraskev Stoyanov AD
  • Ruse, Bulgaria, 7002
    • SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD
  • Ruse, Bulgaria, 7000
    • Medical Center Vitadar Consult OOD
  • Sofia, Bulgaria, 1303
    • "MC Asklepion - researches in human medicine"" EOOD
  • Sofia, Bulgaria, 1784
    • "Acibadem City Clinic UMHAT" EOOD
  • Gabrovo
    • Sevlievo, Gabrovo, Bulgaria, 5400
      • "Medical Center-1- Sevlievo" EOOD
• Czechia
  • Hradec Kralove, Czechia, 50012
    • Hepato-Gastroenterologie HK, s.r.o.
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Slany, Czechia, 274 01
    • Nemocnice Slany, p.o.
  • Strakonice, Czechia, 386 01
    • Nemocnice Strakonice, a.s., Interni oddeleni
• Denmark
  • Frederikssund, Denmark, 3600
    • Nordsjaellands Hospital Frederikssund
  • Hilleroed, Denmark, 3400
    • Nordsjaellands hospital Hilleroed
  • Hvidovre, Denmark, 2650
    • Amager og Hvidovre Hospital
  • Odense, Denmark, 5000
    • Odense Universitetshospital
• Georgia
  • Tbilisi, Georgia, 0112
    • Research Institute of Clinical Medicine
  • Tbilisi, Georgia, 0141
    • The First University Clinic of TSMU
• Germany
  • Berlin, Germany, 10318
    • Paian MED Research GmbH
  • Berlin, Germany, 10825
    • Gastrostudien GbR
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede e.V.
  • Dachau, Germany, 85221
    • MVZ Dachau - Patientenzentrum
  • Dachau, Germany, 85221
    • MVZ Dachau
  • Hamburg, Germany, 22559
    • Asklepios Westklinikum Hamburg
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein
  • Leipzig, Germany, 04103
    • EUGASTRO GmbH
• Hungary
  • Bekescsaba, Hungary, 5600
    • Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz
  • Budapest, Hungary, 1136
    • Pannonia Maganorvosi Centrum
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem, Ii. Belgyogyaszati Klinika
  • Budapest, Hungary, 1125
    • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I. Belgyogyaszati Gasztroenterologiai Osztaly
  • Szekszard, Hungary, 7100
    • Tolna Megyei Balassa János Kórház
  • Vac, Hungary, 2600
    • Javorszky Odon Korhaz, Gasztroenterologia
• Israel
  • Bat-Yam, Israel, 5962025
    • Clalit Health Services
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Tel Aviv, Israel, 6203854
    • Diabetes and Endocrinology Unit
  • Tel Aviv, Israel, 6203854
    • Migdal Hamea Clinic
• Italy
  • Modena, Italy, 41124
    • AOU Policlinico di Modena
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Integrata Udine
  • BO
    • Bologna, BO, Italy, 40138
      • AOU Sant'Orsola-Malpighi
  • Bari
    • Castellana Grotte, Bari, Italy, 70013
      • Irccs Saverio de Bellis
  • ME
    • Messina, ME, Italy, 98125
      • A.O.U. Policlinico G. Martino
  • Milan (MI)
    • Rozzano, Milan (MI), Italy, 20089
      • Istituto Clinico Humanitas
  • Milano (MI)
    • Rho, Milano (MI), Italy, 20017
      • ASST Rhodense - Ospedale di Circolo di Rho
  • PI
    • Pisa, PI, Italy, 56124
      • Azienda Ospedaliero Universitaria Pisana
  • RM
    • Roma, RM, Italy, 00128
      • Policlinico Universitario Campus Biomedico
• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
• Poland
  • Bialystok, Poland, 15-950
    • SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego w Bialymstoku
  • Kielce, Poland, 25-355
    • ETG Kielce
  • Lublin, Poland, 20-582
    • GASTROMED Sp. z o.o.
  • Poznan, Poland, 61-113
    • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
  • Pulawy, Poland, 24-100
    • KO-MED Centra Kliniczne Pulawy
  • Sopot, Poland, 81-756
    • ENDOSKOPIA Sp. z o. o.
  • Tychy, Poland, 43-100
    • H-T. Centrum Medyczne
  • Warszawa, Poland, 00-728
    • WIP Warsaw IBD Point Profesor Kierkus
  • Warszawa, Poland, 00-635
    • Centrum Zdrowia MDM
  • Wloclawek, Poland, 87-800
    • Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.
  • Wroclaw, Poland, 53-114
    • Lexmedica
  • Wroclaw, Poland, 51-162
    • Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
  • Wroclaw, Poland, 50-449
    • Melita Medical Sp z o.o.
  • Wroclaw, Poland, 54-144
    • EMC Instytut Medyczny S.A., Szpital Specjalistyczny EuroMediCare z Przychodnia
• Romania
  • Bucuresti, Romania, 020125
    • Spitalul Clinic Colentina, Sectia de Gastroenterologie
  • Sector 1,
    • Bucuresti, Sector 1,, Romania, 010825
      • Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti
  • Timis
    • Timisoara, Timis, Romania, 300002
      • S.C. Cabinet Particular Policlinic Algomed SRL
• Russian Federation
  • Moscow, Russian Federation, 105554
    • LLC "Olla-Med"
  • Moscow, Russian Federation, 119435
    • FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University)
  • Novosibirsk, Russian Federation, 630005
    • Limited Liability Company "Medicinsky Center SibNovoMed"
  • Novosibirsk, Russian Federation, 630007
    • Novosibirskiy Gastrocenter
  • Novosibirsk, Russian Federation, 630007
    • LLC Novosibirskiy Gastrocentr
  • Novosibirsk, Russian Federation, 630117
    • Federal State Budgetary Scientific Institution
  • Omsk, Russian Federation, 644050
    • FGBOU VO OmGMU Minzdrava Rossii
  • Rostov-on-Don, Russian Federation, 344022
    • FSBEI HE "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation
  • Ryazan, Russian Federation, 390039
    • State Budgetary Institution of Ryazan Region "Regional Clinical Hospital"
  • Saint-Petersburg, Russian Federation, 195220
    • RIAT Limited Liability Company (RIAT LLC)
  • Saint-Petersburg, Russian Federation, 195257
    • Saint-Petersburg State Budgetary Healthcare Institution
  • Samara, Russian Federation, 443011
    • Medical University REAVIZ
  • Samara, Russian Federation, 443029
    • Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"
  • Samara, Russian Federation, 443063
    • LLC Medical Company Hepatolog
  • Samara, Russian Federation, 443076
    • LLC Medical Company Hepatolog
  • Yaroslavl, Russian Federation, 150062
    • State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Hospital Centre Zvezdara Clinic for Internal Diseases
  • Belgrade, Serbia, 11080
    • Clinical Hospital Centre Bezanijska Kosa Clinic for Internal Medicine
  • Kragujevac, Serbia, 34000
    • Clinical Centre of Kragujevac
  • Nis, Serbia, 18000
    • Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
  • Subotica, Serbia, 24000
    • General Hospital Subotica
  • Zemun, Belgrade, Serbia, 11080
    • Clinical Hospital Center Zemun
  • Zrenjanin, Serbia, 23000
    • General Hospital "Djordje Joanovic"
• Slovakia
  • Bratislava, Slovakia, 82107
    • Abawi spol. s r.o
  • Nitra, Slovakia, 949 01
    • KM Management spol. s.r.o.
  • Sahy, Slovakia, 936 01
    • MUDr. Frantisek Horvath Gastroenterologia
  • Vranov nad Toplou, Slovakia, 093 01
    • Endomed, s.r.o.
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitari I Politecnic La Fe
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundación Alcorcón
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro de Majadahonda
• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe Universitesi Tip Fakultesi
  • Ankara, Turkey, 06590
    • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
  • Ankara, Turkey, 06100
    • Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi, Ic Hastaliklari Anabilim Dali,
  • Ankara, Turkey, 06100
    • Ankara Universitesi Tip Fakultesi, Ibn-i-Sina Hastanesi
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey, 34093
    • İstanbul Üniversitesi İstanbul Tıp Fakültesi
  • Kayseri, Turkey, 38039
    • Erciyes Universitesi Tip Fakultesi
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi
  • Kozlu Zonguldak, Turkey, 67600
    • Bulent Ecevit Universitesi Tip Fakultesi
  • Mersin, Turkey, 33110
    • Mersin Universitesi Tip Fakultesi Hastanesi
  • Zonguldak, Turkey, 67600
    • Bulent Ecevit Universitesi Tip Fakultesi
• Ukraine
  • Chernivtsi, Ukraine, 58000
    • Regional Consultative Polyclinic
  • Chernivtsi, Ukraine, 58001
    • Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department,
  • Kharkiv, Ukraine, 61037
    • MNCECCH No.2 n.a. PROF O.O. SHALIMOV of KHARKIV CITY COUNCIL
  • Kherson, Ukraine, 73000
    • Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olga Tropiny"
  • Kropyvnytskyi, Ukraine, 25006
    • Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center
  • Kyiv, Ukraine, 01030
    • Kyiv Municipal Clinical Hospital #18, Proctology Department
  • Kyiv, Ukraine, 03680
    • Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center
  • Lviv, Ukraine, 79007
    • Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway
  • Lviv, Ukraine, 79059
    • Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital"
  • Odesa, Ukraine, 65025
    • Municipal Institution "Odesa Regional Clinical Hospital"
  • Ternopil, Ukraine, 46002
    • Municipal Institution of Ternopil Regional Council Ternopil University Hospital
  • Uzhgorod, Ukraine, 88009
    • Municipal Institution "Uzhgorod Regional Hospital"
  • Uzhgorod, Ukraine, 88018
    • Zakarpattia Regional Clinical Hospital n.a. A. Novak,
  • Vinnytsia, Ukraine, 21018
    • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Dothan Surgery Center
    • Dothan, Alabama, United States, 36305
      • Gut P.C., dba Digestive Health Specialists of the Southeast
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials Services Inc.
    • Los Angeles, California, United States, 90045
      • Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En-
    • San Diego, California, United States, 92123
      • Medical Associates Research Group
    • San Diego, California, United States, 92103
      • Clinical Application Laboratories, INC.
    • San Diego, California, United States, 92103
      • San Diego Endoscopy Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
    • Colorado Springs, Colorado, United States, 80903
      • Front Range Endoscopy Center
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Institute
    • Bristol, Connecticut, United States, 06010
      • Bristol Hospital
    • Plainville, Connecticut, United States, 06062
      • Central Connecticut Endoscopy Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • West Coast Endoscopy Center
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinics
    • Orlando, Florida, United States, 32819
      • HMD Research LLC
    • Orlando, Florida, United States, 32811
      • Millenia Surgery Center
    • Orlando, Florida, United States, 32835
      • Orlando Gastroenterology, PA
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Endoscopy Center
    • Chevy Chase, Maryland, United States, 20815
      • Feldman ENT
    • Chevy Chase, Maryland, United States, 20815
      • MGG Group Co. Inc., Chevy Chase Clinical Research
    • Columbia, Maryland, United States, 21045
      • Gastro Center of Maryland
    • Columbia, Maryland, United States, 21045
      • Cascades Endoscopy Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Chestnut Hill, Massachusetts, United States, 02467
      • Brigham and Women's Hospital
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • NYU Clinical Cancer Center
    • New York, New York, United States, 10021
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • New York, New York, United States, 10021
      • Weill Cornell Medical College - New York Presbyterian Hospital
    • New York, New York, United States, 10016
      • Concorde Medical Group, PLLC
    • New York, New York, United States, 10016
      • Kips Bay Endoscopy Center
    • New York, New York, United States, 10016
      • NYU Medical Science Building
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital-Weill Cornell Medical College
    • New York, New York, United States, 10065
      • Weill Cornell Medical College-New York Presbyterian Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7080
      • University of North Carolina at Chapel Hill
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals
    • Chapel Hill, North Carolina, United States, 27517
      • UNC Hospitals Endoscopy Center at Meadowmont
    • Chapel Hill, North Carolina, United States, 27599-7064
      • University of North Carolina at Chapel Hill
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists, Inc.
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75235
      • Parkland Health and Hospital System
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center-Clements University Hospital
    • Dallas, Texas, United States, 75390-8887
      • UT Southwestern Medical Center - CRU Aston
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine- Baylor Medical Center
    • Houston, Texas, United States, 77098
      • Gulf Coast Research Group
    • Houston, Texas, United States, 77030
      • Baylor St. Luke's Medical Center Endoscopy-McNair Campus
    • Keller, Texas, United States, 76248
      • Lonestar Endoscopy, LLP
    • San Antonio, Texas, United States, 78229
      • Sagact, Pllc.
    • San Antonio, Texas, United States, 78229
      • Sagact, Pllc
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants
    • Southlake, Texas, United States, 76092
      • Lonestar Endoscopy, LLP
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Verity Research
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
    • Richmond, Virginia, United States, 23249
      • McGuire DVAMC
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-06651600 Drug Dose Level 1; Delivered orally for 8 weeks	Drug: PF-06651600 or Placebo; Delivered orally for 8 weeks.
Experimental: PF-06651600 Drug Dose Level 2; Delivered orally for 8 weeks	Drug: PF-06651600 or Placebo; Delivered orally for 8 weeks.
Experimental: PF-06651600 Drug Dose Level 3; Delivered orally for 8 weeks.	Drug: PF-06651600 or Placebo; Delivered orally for 8 weeks.
Placebo Comparator: PF-06651600 Placebo; Delivered orally for 8 weeks.	Drug: PF-06651600 or Placebo; Delivered orally for 8 weeks.
Experimental: PF-06700841 Drug Dose Level 1; Delivered orally for 8 weeks	Drug: PF-06700841 or Placebo; Delivered orally for 8 weeks.
Experimental: PF-06700841 Drug Dose Level 2; Delivered orally for 8 weeks.	Drug: PF-06700841 or Placebo; Delivered orally for 8 weeks.
Experimental: PF-06700841 Drug Dose Level 3; Delivered orally for 8 weeks.	Drug: PF-06700841 or Placebo; Delivered orally for 8 weeks.
Placebo Comparator: PF-06700841 Placebo; Delivered orally for 8 weeks.	Drug: PF-06700841 or Placebo; Delivered orally for 8 weeks.
Experimental: PF-06651600 Drug Dose Level 4; Delivered orally for 24 weeks.	Drug: PF-06651600; Delivered orally for 24 weeks.
Experimental: PF-06700841 Drug Dose Level 4; Delivered orally for 24 weeks.	Drug: PF-06700841; Delivered orally for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Mayo Score at Week 8 (Induction Period)	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)	An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.	From Week 8 up to Week 32
Number of Participants With Laboratory Test Abnormalities (Chronic Period)	The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance.	From Week 8 to Week 32
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)	The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.	From Week 8 to Week 32
Number of Participants With Abnormal Vital Signs Data (Chronic Period)	The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.	From Week 8 to Week 32
Number of Participants With Abnormal ECG Findings (Chronic Period)	The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below.	Week 8 to Week 32
Number of Participants With Serious Infections (Chronic Period)	Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.	Week 8 to Week 32
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)	The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL).	Week 8 to Week 32
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)	The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.	Week 8 to Week 32
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)	An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.	From Day 1 up to Week 8
Number of Participants With Laboratory Test Abnormalities (Induction Period)	The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.	From Day 1 up to Week 8
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)	The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.	From Day 1 up to Week 8
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)	The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL)	From Day 1 up to Week 8
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)	The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.	From Day 1 up to Week 8
Number of Participants With Abnormal Vital Signs Data (Induction Period)	The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.	From screening to Week 8
Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)	The number of participants with abnormal ECG findings during the induction period (from Day 1 to Week 8) are reported below. The criteria of test abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.	From screening to Week 8
Number of Participants With Serious Infections (Induction Period)	Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials including Listeria encephalitis, Pneumonia, Viral infection.	From Day 1 up to Week 8
Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.	Week 8
Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic subscore appearance was defined at Mayo endoscopic subscore of ≤1.	Week 8
Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response was defined as decrease from baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.	Week 8
Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Endoscopic remission was defined as endoscopic subscore of 0.	Week 8
Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Symptomatic remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscores of 0.	Week 8
Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Deep remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a zero on both endoscopic and rectal bleeding subscore.	Week 8
Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. The partial Mayo score does not incorporate the endoscopy score and the partial Mayo score ranges from 0 to 9.	Baseline, Weeks 2, 4 and 8
Change From Baseline in Total Mayo Score at Week 8 (Induction Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.	Baseline, Week 8
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)	IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease specific quality of life in participants with inflammatory bowel disease (IBD). The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.	Week 4 and Week 8
Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period)	IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. Baseline value is defined as the last non-missing measurement collected prior to or on Day 1.	Baseline, Weeks 4 and 8
Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)	IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.	Week 4 and Week 8
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)	IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.	Baseline, Week 4 and 8
Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period)	IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. The improvement in IBDQ bowel symptom domain was defined as an increase of ≥1.2 points from baseline in average score among bowel symptoms domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).	Week 4 and Week 8
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)	The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). These 8 domains can also be summarized as physical and mental component scores. The summary component scores, Physical Component Summary (PCS) and Mental Component Summary (MCS), are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH . All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The minimum and maximum scores of the PCS Score are 6.1 and 79.7, respectively. The minimum and maximum scores of the MCS Score are -3.8 and 78.7, respectively.	Week 4 and Week 8
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)	For EQ-5D 3L, participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state. The EQ-5D VAS records the respondent's self rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).	Week 4 and Week 8
Total Mayo Score at Week 32 (Chronic Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.	Week 32
Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.	Week 32
Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic appearance was defined at Mayo endoscopic subscore of ≤1.	Week 32

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Mayo Score at Week 32 (Chronic Period)	The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.	Week 32

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2017
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Mayo score
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; PF-06700841
• Other Study ID Numbers: B7981005; VIBRATO (Other Identifier: Alias Study Number); 2016-003708-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No