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

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PF-06651600 or Placebo

PF-06700841 or Placebo

PF-06700841

PF-06651600

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Mayo score

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dothan Surgery Center
Gut P.C., dba Digestive Health Specialists of the Southeast
Long Beach Clinical Trials Services Inc.
Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En-
Clinical Application Laboratories, INC.
San Diego Endoscopy Center
Medical Associates Research Group
Front Range Endoscopy Center
Peak Gastroenterology Associates
Bristol Hospital
Connecticut Clinical Research Institute
Central Connecticut Endoscopy Center
West Coast Endoscopy Center
University of Miami Hospital and Clinics
University of Miami Hospital
Millenia Surgery Center
HMD Research LLC
Orlando Gastroenterology, PA
Southwest Gastroenterology
Chevy Chase Endoscopy Center
Feldman ENT
MGG Group Co. Inc., Chevy Chase Clinical Research
Cascades Endoscopy Center
Gastro Center of Maryland
Brigham and Women's Hospital
Brigham and Women's Hospital
Concorde medical Group, PLLC
Kips Bay Endoscopy Center
New York University Langone Medical Center
NYU Clinical Cancer Center
NYU Langone Medical Center
NYU Medical Science Building
Weill Cornell Medical College - New York Presbyterian Hospital
Weill Cornell Medical College
New York Presbyterian Hospital-Weill Cornell Medical College
Weill Cornell Medical College-New York Presbyterian Hospital
Weill Cornell Medical College
University of Rochester Medical Center
UNC Hospitals
UNC Hospitals Endoscopy Center at Meadowmont
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill
Digestive Disease Specialists, Inc.
Gastro One
Parkland Health and Hospital System
UT Southwestern Medical Center - CRU Aston
UT Southwestern Medical Center-Clements University Hospital
UT Southwestern Medical Center
Baylor College of Medicine- Baylor Medical Center
Baylor St. Luke's Medical Center Endoscopy-McNair Campus
Gulf Coast Research Group
Lonestar Endoscopy, LLP
Sagact, Pllc.
Sagact, Pllc
Lonestar Endoscopy, LLP
Texas Digestive Disease Consultants
Verity Research
Blue Ridge Medical Research
McGuire DVAMC
University of Washington
AKH Wien Universitaetsklinik fuer Innere Medizin III
"Medical Center-1- Sevlievo" EOOD
"MHAT-Blagoevgrad" AD
MHAT Dobrich AD
MC Hipocrat-2000 OOD
MHAT Prof. Dr. Paraskev Stoyanov AD
Medical Center Vitadar Consult OOD
SHATPPD dr. Dimitar Gramatikov - Ruse EOOD
"MC Asklepion - researches in human medicine"" EOOD
"Acibadem City Clinic UMHAT" EOOD
Hepato-Gastroenterologie HK, s.r.o.
Fakultni nemocnice v Motole
Nemocnice Slany, p.o.
Nemocnice Strakonice, a.s., interni oddeleni
Nordsjaellands Hospital Frederikssund
Nordsjaellands Hospital Hilleroed
Amager og Hvidovre Hospital
Odense Universitetshospital
Research institute of Clinical Medicine
The First University Clinic of TSMU
Paian MED Research GmbH
Gastrostudien GbR
Krankenhaus Waldfriede e.V.
MVZ Dachau - Patientenzentrum
MVZ Dachau
Asklepios Westklinikum Hamburg
Universitaetsklinikum Schleswig-Holstein
Eugastro GmbH
Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz
Semmelweis Egyetem, II. Belgyogyaszati Klinika
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I. Belgyogyaszati Gasztroenterologiai Osztaly
Pannonia Maganorvosi Centrum
Tolna Megyei Balassa Janos Korhaz
Javorszky Odon Korhaz, Gasztroenterologia
Clalit Health Services
Shaare Zedek Medical Center
Diabetes and Endocrinology Unit
Migdal Hamea Clinic
IRCCS Saverio De Bellis
AOU Sant'Orsola-Malpighi
A.O.U. Policlinico G. Martino
Istituto Clinico Humanitas
ASST Rhodense - Ospedale di Circolo di Rho
Azienda Ospedaliero Universitaria Pisana
Policlinico Universitario Campus Biomedico
AOU Policlinico di Modena
Azienda Ospedaliera di Padova
Azienda Sanitaria Universitaria Integrata Udine
Kyungpook National University Hospital
Keimyung University Dongsan Hospital
Severance Hospital, Yonsei University Health System
The Catholic University of Korea, Seoul St. Mary's Hospital
SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego w Bialymstoku
ETG Kielce
Gastromed Sp. z o.o.
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
KO-MED Centra Kliniczne Pulawy
ENDOSKOPIA Sp. z o. o.
H-T. Centrum Medyczne
Centrum Zdrowia MDM
WIP Warsaw IBD Point Profesor Kierkus
Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.
Melita Medical Sp z o.o.
Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
Lexmedica
EMC Instytut Medyczny S.A., Szpital Specjalistyczny EuroMediCare z Przychodnia
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti
S.C. Cabinet Particular Policlinic Algomed SRL
Spitalul Clinic Colentina, Sectia de Gastroenterologie
LLC "Olla-Med"
FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University)
Limited Liability Company "Medicinsky Center SibNovoMed"
LLC Novosibirskiy Gastrocentr
Novosibirskiy Gastrocenter
Federal State Budgetary Scientific Institution
FGBOU VO OmGMU Minzdrava Rossii
FSBEI HE "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation
State Budgetary Institution of Ryazan Region "Regional Clinical Hospital"
RIAT Limited Liability Company (RIAT LLC)
Saint-Petersburg State Budgetary Healthcare Institution
Medical University REAVIZ
Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"
LLC Medical Company Hepatolog
LLC Medical Company Hepatolog
State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital
Clinical Hospital Centre Zvezdara Clinic for Internal Diseases
Clinical Hospital Centre Bezanijska Kosa Clinic for Internal Medicine
Clinical Centre of Kragujevac
Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
General Hospital Subotica
Clinical Hospital Center Zemun
General Hospital "Djordje Joanovic"
Abawi spol. s r.o
KM Management spol. s.r.o.
MUDr. Frantisek Horvath Gastroenterologia
ENDOMED, s.r.o.
Hospital Universitari de Bellvitge
Hospital Universitario Marques de Valdecilla
Hospital Universitario Fundacion Alcorcon
Hospital Universitario Puerta de Hierro de Majadahonda
Hospital Clinic de Barcelona
Hospital Universitario Virgen del Rocio
Hospital Universitari i Politecnic La Fe
Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi, Ic Hastaliklari Anabilim Dali,
Ankara Universitesi Tip Fakultesi, Ibn-i-Sina Hastanesi
Hacettepe Universitesi Tip Fakultesi
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul Universitesi Istanbul Tıp Fakultesi
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Erciyes Universitesi Tip Fakultesi
Kocaeli Universitesi Tip Fakultesi
Bulent Ecevit Universitesi Tip Fakultesi
Mersin Universitesi Tip Fakultesi Hastanesi
Bulent Ecevit Universitesi Tip Fakultesi
Regional Consultative Polyclinic
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department,
MNCECCH No.2 n.a. PROF O.O. SHALIMOV of KHARKIV CITY COUNCIL
Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olga Tropiny"
Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center
Kyiv Municipal Clinical Hospital #18, Proctology Department
Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center
Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway
Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital"
Municipal Institution "Odesa Regional Clinical Hospital"
Municipal Institution of Ternopil regional council Ternopil University Hospital
Municipal Institution "Uzhgorod Regional Hospital"
Zakarpattia Regional Clinical Hospital n.a. A. Novak,
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

PF-06651600 Drug Dose Level 1

PF-06651600 Drug Dose Level 2

PF-06651600 Drug Dose Level 3

PF-06651600 Placebo

PF-06700841 Drug Dose Level 1

PF-06700841 Drug Dose Level 2

PF-06700841 Drug Dose Level 3

PF-06700841 Placebo

PF-06651600 Drug Dose Level 4

PF-06700841 Drug Dose Level 4

Arm Description

Delivered orally for 8 weeks

Delivered orally for 8 weeks.

Delivered orally for 8 weeks

Delivered orally for 8 weeks.

Delivered orally for 24 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Number of Participants With Laboratory Test Abnormalities (Chronic Period)

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.

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.

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.

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.

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).

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.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)

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.

Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)

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)

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.

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.

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.

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.

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.

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.

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.

Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period)

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.

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.

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.

Change From Baseline in Total Mayo Score at Week 8 (Induction Period)

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.

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.

Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)

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)

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).

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.

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).

Total Mayo Score at Week 32 (Chronic Period)

Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period)

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.

Full Information

NCT ID

NCT02958865

First Posted

November 4, 2016

Last Updated

June 27, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02958865

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

February 3, 2017 (Actual)

Primary Completion Date

May 10, 2021 (Actual)

Study Completion Date

May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Mayo score

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

319 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-06651600 Drug Dose Level 1

Arm Type

Experimental

Arm Description

Delivered orally for 8 weeks

Arm Title

PF-06651600 Drug Dose Level 2

Arm Type

Experimental

Arm Description

Delivered orally for 8 weeks

Arm Title

PF-06651600 Drug Dose Level 3

Arm Type

Experimental

Arm Description

Delivered orally for 8 weeks.

Arm Title

PF-06651600 Placebo

Arm Type

Placebo Comparator

Arm Description

Delivered orally for 8 weeks.

Arm Title

PF-06700841 Drug Dose Level 1

Arm Type

Experimental

Arm Description

Delivered orally for 8 weeks

Arm Title

PF-06700841 Drug Dose Level 2

Arm Type

Experimental

Arm Description

Delivered orally for 8 weeks.

Arm Title

PF-06700841 Drug Dose Level 3

Arm Type

Experimental

Arm Description

Delivered orally for 8 weeks.

Arm Title

PF-06700841 Placebo

Arm Type

Placebo Comparator

Arm Description

Delivered orally for 8 weeks.

Arm Title

PF-06651600 Drug Dose Level 4

Arm Type

Experimental

Arm Description

Delivered orally for 24 weeks.

Arm Title

PF-06700841 Drug Dose Level 4

Arm Type

Experimental

Arm Description

Delivered orally for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

PF-06651600 or Placebo

Intervention Description

Delivered orally for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

PF-06700841 or Placebo

Intervention Description

Delivered orally for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

PF-06700841

Intervention Description

Delivered orally for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

PF-06651600

Intervention Description

Delivered orally for 24 weeks.

Primary Outcome Measure Information:

Title

Total Mayo Score at Week 8 (Induction Period)

Description

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)

Description

Time Frame

From Week 8 up to Week 32

Title

Number of Participants With Laboratory Test Abnormalities (Chronic Period)

Description

Time Frame

From Week 8 to Week 32

Title

Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)

Description

Time Frame

From Week 8 to Week 32

Title

Number of Participants With Abnormal Vital Signs Data (Chronic Period)

Description

The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.

Time Frame

From Week 8 to Week 32

Title

Number of Participants With Abnormal ECG Findings (Chronic Period)

Description

The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below.

Time Frame

Week 8 to Week 32

Title

Number of Participants With Serious Infections (Chronic Period)

Description

Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.

Time Frame

Week 8 to Week 32

Title

Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)

Description

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).

Time Frame

Week 8 to Week 32

Title

Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)

Description

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.

Time Frame

Week 8 to Week 32

Title

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)

Description

Time Frame

From Day 1 up to Week 8

Title

Number of Participants With Laboratory Test Abnormalities (Induction Period)

Description

Time Frame

From Day 1 up to Week 8

Title

Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)

Description

Time Frame

From Day 1 up to Week 8

Title

Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)

Description

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)

Time Frame

From Day 1 up to Week 8

Title

Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)

Description

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.

Time Frame

From Day 1 up to Week 8

Title

Number of Participants With Abnormal Vital Signs Data (Induction Period)

Description

The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.

Time Frame

From screening to Week 8

Title

Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)

Description

Time Frame

From screening to Week 8

Title

Number of Participants With Serious Infections (Induction Period)

Description

Time Frame

From Day 1 up to Week 8

Title

Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period)

Description

Time Frame

Week 8

Title

Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period)

Description

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.

Time Frame

Week 8

Title

Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period)

Description

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.

Time Frame

Week 8

Title

Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period)

Description

Time Frame

Week 8

Title

Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period)

Description

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.

Time Frame

Week 8

Title

Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period)

Description

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.

Time Frame

Week 8

Title

Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)

Description

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.

Time Frame

Baseline, Weeks 2, 4 and 8

Title

Change From Baseline in Total Mayo Score at Week 8 (Induction Period)

Description

Time Frame

Baseline, Week 8

Title

Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)

Description

Time Frame

Week 4 and Week 8

Title

Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period)

Description

Time Frame

Baseline, Weeks 4 and 8

Title

Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)

Description

Time Frame

Week 4 and Week 8

Title

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)

Description

Time Frame

Baseline, Week 4 and 8

Title

Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period)

Description

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).

Time Frame

Week 4 and Week 8

Title

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)

Description

Time Frame

Week 4 and Week 8

Title

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)

Description

Time Frame

Week 4 and Week 8

Title

Total Mayo Score at Week 32 (Chronic Period)

Description

Time Frame

Week 32

Title

Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period)

Description

Time Frame

Week 32

Title

Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period)

Description

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.

Time Frame

Week 32

Other Pre-specified Outcome Measures:

Title

Change From Baseline in Total Mayo Score at Week 32 (Chronic Period)

Description

Time Frame

Week 32

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Dothan Surgery Center

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36301

Country

United States

Facility Name

Gut P.C., dba Digestive Health Specialists of the Southeast

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36305

Country

United States

Facility Name

Long Beach Clinical Trials Services Inc.

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En-

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Clinical Application Laboratories, INC.

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

San Diego Endoscopy Center

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Medical Associates Research Group

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Front Range Endoscopy Center

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80903

Country

United States

Facility Name

Peak Gastroenterology Associates

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Bristol Hospital

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Connecticut Clinical Research Institute

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Central Connecticut Endoscopy Center

City

Plainville

State/Province

Connecticut

ZIP/Postal Code

06062

Country

United States

Facility Name

West Coast Endoscopy Center

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

University of Miami Hospital and Clinics

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

University of Miami Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Millenia Surgery Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32811

Country

United States

Facility Name

HMD Research LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Orlando Gastroenterology, PA

City

Orlando

State/Province

Florida

ZIP/Postal Code

32835

Country

United States

Facility Name

Southwest Gastroenterology

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Facility Name

Chevy Chase Endoscopy Center

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Feldman ENT

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

MGG Group Co. Inc., Chevy Chase Clinical Research

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Cascades Endoscopy Center

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21045

Country

United States

Facility Name

Gastro Center of Maryland

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21045

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Brigham and Women's Hospital

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

Facility Name

Concorde medical Group, PLLC

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Kips Bay Endoscopy Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

New York University Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

NYU Clinical Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

NYU Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

NYU Medical Science Building

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Weill Cornell Medical College - New York Presbyterian Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

New York Presbyterian Hospital-Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Weill Cornell Medical College-New York Presbyterian Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

UNC Hospitals

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

UNC Hospitals Endoscopy Center at Meadowmont

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7064

Country

United States

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7080

Country

United States

Facility Name

Digestive Disease Specialists, Inc.

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Gastro One

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Parkland Health and Hospital System

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

UT Southwestern Medical Center - CRU Aston

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8887

Country

United States

Facility Name

UT Southwestern Medical Center-Clements University Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Baylor College of Medicine- Baylor Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Baylor St. Luke's Medical Center Endoscopy-McNair Campus

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Gulf Coast Research Group

City

Houston

State/Province

Texas

ZIP/Postal Code

77098

Country

United States

Facility Name

Lonestar Endoscopy, LLP

City

Keller

State/Province

Texas

ZIP/Postal Code

76248

Country

United States

Facility Name

Sagact, Pllc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Sagact, Pllc

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Lonestar Endoscopy, LLP

City

Southlake

State/Province

Texas

ZIP/Postal Code

76092

Country

United States

Facility Name

Texas Digestive Disease Consultants

City

Southlake

State/Province

Texas

ZIP/Postal Code

76092

Country

United States

Facility Name

Verity Research

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Blue Ridge Medical Research

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24502

Country

United States

Facility Name

McGuire DVAMC

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

AKH Wien Universitaetsklinik fuer Innere Medizin III

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

"Medical Center-1- Sevlievo" EOOD

City

Sevlievo

State/Province

Gabrovo

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

"MHAT-Blagoevgrad" AD

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

MHAT Dobrich AD

City

Dobrich

ZIP/Postal Code

9300

Country

Bulgaria

Facility Name

MC Hipocrat-2000 OOD

City

Haskovo

ZIP/Postal Code

6300

Country

Bulgaria

Facility Name

MHAT Prof. Dr. Paraskev Stoyanov AD

City

Lovech

ZIP/Postal Code

5500

Country

Bulgaria

Facility Name

Medical Center Vitadar Consult OOD

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

SHATPPD dr. Dimitar Gramatikov - Ruse EOOD

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

"MC Asklepion - researches in human medicine"" EOOD

City

Sofia

ZIP/Postal Code

1303

Country

Bulgaria

Facility Name

"Acibadem City Clinic UMHAT" EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Hepato-Gastroenterologie HK, s.r.o.

City

Hradec Kralove

ZIP/Postal Code

50012

Country

Czechia

Facility Name

Fakultni nemocnice v Motole

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Nemocnice Slany, p.o.

City

Slany

ZIP/Postal Code

274 01

Country

Czechia

Facility Name

Nemocnice Strakonice, a.s., interni oddeleni

City

Strakonice

ZIP/Postal Code

386 01

Country

Czechia

Facility Name

Nordsjaellands Hospital Frederikssund

City

Frederikssund

ZIP/Postal Code

3600

Country

Denmark

Facility Name

Nordsjaellands Hospital Hilleroed

City

Hilleroed

ZIP/Postal Code

3400

Country

Denmark

Facility Name

Amager og Hvidovre Hospital

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Odense Universitetshospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Research institute of Clinical Medicine

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

The First University Clinic of TSMU

City

Tbilisi

ZIP/Postal Code

0141

Country

Georgia

Facility Name

Paian MED Research GmbH

City

Berlin

ZIP/Postal Code

10318

Country

Germany

Facility Name

Gastrostudien GbR

City

Berlin

ZIP/Postal Code

10825

Country

Germany

Facility Name

Krankenhaus Waldfriede e.V.

City

Berlin

ZIP/Postal Code

14163

Country

Germany

Facility Name

MVZ Dachau - Patientenzentrum

City

Dachau

ZIP/Postal Code

85221

Country

Germany

Facility Name

MVZ Dachau

City

Dachau

ZIP/Postal Code

85221

Country

Germany

Facility Name

Asklepios Westklinikum Hamburg

City

Hamburg

ZIP/Postal Code

22559

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Eugastro GmbH

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Semmelweis Egyetem, II. Belgyogyaszati Klinika

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I. Belgyogyaszati Gasztroenterologiai Osztaly

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Pannonia Maganorvosi Centrum

City

Budapest

ZIP/Postal Code

1136

Country

Hungary

Facility Name

Tolna Megyei Balassa Janos Korhaz

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Javorszky Odon Korhaz, Gasztroenterologia

City

Vac

ZIP/Postal Code

2600

Country

Hungary

Facility Name

Clalit Health Services

City

Bat-Yam

ZIP/Postal Code

5962025

Country

Israel

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

ZIP/Postal Code

9103102

Country

Israel

Facility Name

Diabetes and Endocrinology Unit

City

Tel Aviv

ZIP/Postal Code

6203854

Country

Israel

Facility Name

Migdal Hamea Clinic

City

Tel Aviv

ZIP/Postal Code

6203854

Country

Israel

Facility Name

IRCCS Saverio De Bellis

City

Castellana Grotte

State/Province

Bari

ZIP/Postal Code

70013

Country

Italy

Facility Name

AOU Sant'Orsola-Malpighi

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

A.O.U. Policlinico G. Martino

City

Messina

State/Province

ZIP/Postal Code

98125

Country

Italy

Facility Name

Istituto Clinico Humanitas

City

Rozzano

State/Province

Milan (MI)

ZIP/Postal Code

20089

Country

Italy

Facility Name

ASST Rhodense - Ospedale di Circolo di Rho

City

Rho

State/Province

Milano (MI)

ZIP/Postal Code

20017

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Pisana

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Policlinico Universitario Campus Biomedico

City

Roma

State/Province

ZIP/Postal Code

00128

Country

Italy

Facility Name

AOU Policlinico di Modena

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Azienda Ospedaliera di Padova

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Azienda Sanitaria Universitaria Integrata Udine

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Keimyung University Dongsan Hospital

City

Daegu

ZIP/Postal Code

42601

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego w Bialymstoku

City

Bialystok

ZIP/Postal Code

15-950

Country

Poland

Facility Name

ETG Kielce

City

Kielce

ZIP/Postal Code

25-355

Country

Poland

Facility Name

Gastromed Sp. z o.o.

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

Ai Centrum Medyczne Sp. Z O.O. Sp.K.

City

Poznan

ZIP/Postal Code

61-113

Country

Poland

Facility Name

KO-MED Centra Kliniczne Pulawy

City

Pulawy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

ENDOSKOPIA Sp. z o. o.

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Facility Name

H-T. Centrum Medyczne

City

Tychy

ZIP/Postal Code

43-100

Country

Poland

Facility Name

Centrum Zdrowia MDM

City

Warszawa

ZIP/Postal Code

00-635

Country

Poland

Facility Name

WIP Warsaw IBD Point Profesor Kierkus

City

Warszawa

ZIP/Postal Code

00-728

Country

Poland

Facility Name

Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.

City

Wloclawek

ZIP/Postal Code

87-800

Country

Poland

Facility Name

Melita Medical Sp z o.o.

City

Wroclaw

ZIP/Postal Code

50-449

Country

Poland

Facility Name

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

City

Wroclaw

ZIP/Postal Code

51-162

Country

Poland

Facility Name

Lexmedica

City

Wroclaw

ZIP/Postal Code

53-114

Country

Poland

Facility Name

EMC Instytut Medyczny S.A., Szpital Specjalistyczny EuroMediCare z Przychodnia

City

Wroclaw

ZIP/Postal Code

54-144

Country

Poland

Facility Name

Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti

City

Bucuresti

State/Province

Sector 1,

ZIP/Postal Code

010825

Country

Romania

Facility Name

S.C. Cabinet Particular Policlinic Algomed SRL

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300002

Country

Romania

Facility Name

Spitalul Clinic Colentina, Sectia de Gastroenterologie

City

Bucuresti

ZIP/Postal Code

020125

Country

Romania

Facility Name

LLC "Olla-Med"

City

Moscow

ZIP/Postal Code

105554

Country

Russian Federation

Facility Name

FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University)

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

Limited Liability Company "Medicinsky Center SibNovoMed"

City

Novosibirsk

ZIP/Postal Code

630005

Country

Russian Federation

Facility Name

LLC Novosibirskiy Gastrocentr

City

Novosibirsk

ZIP/Postal Code

630007

Country

Russian Federation

Facility Name

Novosibirskiy Gastrocenter

City

Novosibirsk

ZIP/Postal Code

630007

Country

Russian Federation

Facility Name

Federal State Budgetary Scientific Institution

City

Novosibirsk

ZIP/Postal Code

630117

Country

Russian Federation

Facility Name

FGBOU VO OmGMU Minzdrava Rossii

City

Omsk

ZIP/Postal Code

644050

Country

Russian Federation

Facility Name

FSBEI HE "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation

City

Rostov-on-Don

ZIP/Postal Code

344022

Country

Russian Federation

Facility Name

State Budgetary Institution of Ryazan Region "Regional Clinical Hospital"

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

RIAT Limited Liability Company (RIAT LLC)

City

Saint-Petersburg

ZIP/Postal Code

195220

Country

Russian Federation

Facility Name

Saint-Petersburg State Budgetary Healthcare Institution

City

Saint-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Medical University REAVIZ

City

Samara

ZIP/Postal Code

443011

Country

Russian Federation

Facility Name

Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"

City

Samara

ZIP/Postal Code

443029

Country

Russian Federation

Facility Name

LLC Medical Company Hepatolog

City

Samara

ZIP/Postal Code

443063

Country

Russian Federation

Facility Name

LLC Medical Company Hepatolog

City

Samara

ZIP/Postal Code

443076

Country

Russian Federation

Facility Name

State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Clinical Hospital Centre Zvezdara Clinic for Internal Diseases

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Hospital Centre Bezanijska Kosa Clinic for Internal Medicine

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Clinical Centre of Kragujevac

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

General Hospital Subotica

City

Subotica

ZIP/Postal Code

24000

Country

Serbia

Facility Name

Clinical Hospital Center Zemun

City

Zemun, Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

General Hospital "Djordje Joanovic"

City

Zrenjanin

ZIP/Postal Code

23000

Country

Serbia

Facility Name

Abawi spol. s r.o

City

Bratislava

ZIP/Postal Code

82107

Country

Slovakia

Facility Name

KM Management spol. s.r.o.

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

MUDr. Frantisek Horvath Gastroenterologia

City

Sahy

ZIP/Postal Code

936 01

Country

Slovakia

Facility Name

ENDOMED, s.r.o.

City

Vranov nad Toplou

ZIP/Postal Code

093 01

Country

Slovakia

Facility Name

Hospital Universitari de Bellvitge

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Universitario Marques de Valdecilla

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital Universitario Fundacion Alcorcon

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Hospital Universitario Puerta de Hierro de Majadahonda

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital Universitari i Politecnic La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi, Ic Hastaliklari Anabilim Dali,

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Ankara Universitesi Tip Fakultesi, Ibn-i-Sina Hastanesi

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Hacettepe Universitesi Tip Fakultesi

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Istanbul Universitesi Istanbul Tıp Fakultesi

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Istanbul Universitesi Cerrahpasa Tip Fakultesi

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Erciyes Universitesi Tip Fakultesi

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Kocaeli Universitesi Tip Fakultesi

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Bulent Ecevit Universitesi Tip Fakultesi

City

Kozlu Zonguldak

ZIP/Postal Code

67600

Country

Turkey

Facility Name

Mersin Universitesi Tip Fakultesi Hastanesi

City

Mersin

ZIP/Postal Code

33110

Country

Turkey

Facility Name

Bulent Ecevit Universitesi Tip Fakultesi

City

Zonguldak

ZIP/Postal Code

67600

Country

Turkey

Facility Name

Regional Consultative Polyclinic

City

Chernivtsi

ZIP/Postal Code

58000

Country

Ukraine

Facility Name

Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department,

City

Chernivtsi

ZIP/Postal Code

58001

Country

Ukraine

Facility Name

MNCECCH No.2 n.a. PROF O.O. SHALIMOV of KHARKIV CITY COUNCIL

City

Kharkiv

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olga Tropiny"

City

Kherson

ZIP/Postal Code

73000

Country

Ukraine

Facility Name

Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center

City

Kropyvnytskyi

ZIP/Postal Code

25006

Country

Ukraine

Facility Name

Kyiv Municipal Clinical Hospital #18, Proctology Department

City

Kyiv

ZIP/Postal Code

01030

Country

Ukraine

Facility Name

Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway

City

Lviv

ZIP/Postal Code

79007

Country

Ukraine

Facility Name

Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital"

City

Lviv

ZIP/Postal Code

79059

Country

Ukraine

Facility Name

Municipal Institution "Odesa Regional Clinical Hospital"

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Municipal Institution of Ternopil regional council Ternopil University Hospital

City

Ternopil

ZIP/Postal Code

46002

Country

Ukraine

Facility Name

Municipal Institution "Uzhgorod Regional Hospital"

City

Uzhgorod

ZIP/Postal Code

88009

Country

Ukraine

Facility Name

Zakarpattia Regional Clinical Hospital n.a. A. Novak,

City

Uzhgorod

ZIP/Postal Code

88018

Country

Ukraine

Facility Name

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

30113844

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.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=B7981005

Description

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

Learn more about this trial

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

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