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

• ClinicalTrials.gov Identifier: NCT02958865
• Recruitment Status: Completed
• First Posted: November 8, 2016
• Results First Posted: July 21, 2022
• Last Update Posted: July 21, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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.

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis	Drug: PF-06651600 or Placebo; Drug: PF-06700841 or Placebo; Drug: PF-06700841; Drug: PF-06651600	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 319 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 3, 2017
• Actual Primary Completion Date: May 10, 2021
• Actual Study Completion Date: May 10, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Total Mayo Score at Week 8 (Induction Period) [ Time Frame: Week 8 ]
   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 :

1. Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) [ Time Frame: From Week 8 up to Week 32 ]
   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.
2. Number of Participants With Laboratory Test Abnormalities (Chronic Period) [ Time Frame: From Week 8 to Week 32 ]
   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.
3. Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) [ Time Frame: From Week 8 to Week 32 ]
   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.
4. Number of Participants With Abnormal Vital Signs Data (Chronic Period) [ Time Frame: From Week 8 to Week 32 ]
   The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.
5. Number of Participants With Abnormal ECG Findings (Chronic Period) [ Time Frame: Week 8 to Week 32 ]
   The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below.
6. Number of Participants With Serious Infections (Chronic Period) [ Time Frame: Week 8 to Week 32 ]
   Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.
7. Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) [ Time Frame: Week 8 to Week 32 ]
   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).
8. Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) [ Time Frame: Week 8 to Week 32 ]
   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.
9. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) [ Time Frame: From Day 1 up to Week 8 ]
   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.
10. Number of Participants With Laboratory Test Abnormalities (Induction Period) [ Time Frame: From Day 1 up to Week 8 ]
    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.
11. Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) [ Time Frame: From Day 1 up to Week 8 ]
    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.
12. Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) [ Time Frame: From Day 1 up to Week 8 ]
    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)
13. Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) [ Time Frame: From Day 1 up to Week 8 ]
    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.
14. Number of Participants With Abnormal Vital Signs Data (Induction Period) [ Time Frame: From screening to Week 8 ]
    The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.
15. Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) [ Time Frame: From screening to Week 8 ]
    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.
16. Number of Participants With Serious Infections (Induction Period) [ Time Frame: From Day 1 up to Week 8 ]
    Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials including Listeria encephalitis, Pneumonia, Viral infection.
17. Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) [ Time Frame: Week 8 ]
    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.
18. Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) [ Time Frame: Week 8 ]
    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.
19. Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) [ Time Frame: Week 8 ]
    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.
20. Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) [ Time Frame: Week 8 ]
    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.
21. Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) [ Time Frame: Week 8 ]
    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.
22. Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) [ Time Frame: Week 8 ]
    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.
23. Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) [ Time Frame: Baseline, Weeks 2, 4 and 8 ]
    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.
24. Change From Baseline in Total Mayo Score at Week 8 (Induction Period) [ Time Frame: Baseline, Week 8 ]
    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.
25. Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) [ Time Frame: Week 4 and Week 8 ]
    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.
26. Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) [ Time Frame: Baseline, Weeks 4 and 8 ]
    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.
27. Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) [ Time Frame: Week 4 and Week 8 ]
    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.
28. 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) [ Time Frame: Baseline, Week 4 and 8 ]
    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.
29. Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) [ Time Frame: Week 4 and Week 8 ]
    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).
30. 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) [ Time Frame: Week 4 and Week 8 ]
    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.
31. 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) [ Time Frame: Week 4 and Week 8 ]
    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).
32. Total Mayo Score at Week 32 (Chronic Period) [ Time Frame: Week 32 ]
    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.
33. Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) [ Time Frame: Week 32 ]
    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.
34. Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) [ Time Frame: Week 32 ]
    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.

Other Outcome Measures:

1. Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) [ Time Frame: Week 32 ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Alabama

Dothan Surgery Center

Dothan, Alabama, United States, 36301

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

Dothan, Alabama, United States, 36305

United States, California

Long Beach Clinical Trials Services Inc.

Long Beach, California, United States, 90806

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

Los Angeles, California, United States, 90045

Clinical Application Laboratories, INC.

San Diego, California, United States, 92103

San Diego Endoscopy Center

San Diego, California, United States, 92103

Medical Associates Research Group

San Diego, California, United States, 92123

United States, Colorado

Front Range Endoscopy Center

Colorado Springs, Colorado, United States, 80903

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States, 80907

United States, Connecticut

Bristol Hospital

Bristol, Connecticut, United States, 06010

Connecticut Clinical Research Institute

Bristol, Connecticut, United States, 06010

Central Connecticut Endoscopy Center

Plainville, Connecticut, United States, 06062

United States, Florida

West Coast Endoscopy Center

Clearwater, Florida, United States, 33756

University of Miami Hospital and Clinics

Miami, Florida, United States, 33136

University of Miami Hospital

Miami, Florida, United States, 33136

Millenia Surgery Center

Orlando, Florida, United States, 32811

HMD Research LLC

Orlando, Florida, United States, 32819

Orlando Gastroenterology, PA

Orlando, Florida, United States, 32835

United States, Illinois

Southwest Gastroenterology

Oak Lawn, Illinois, United States, 60453

United States, Maryland

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

Chevy Chase, Maryland, United States, 20815

Cascades Endoscopy Center

Columbia, Maryland, United States, 21045

Gastro Center of Maryland

Columbia, Maryland, United States, 21045

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States, 02467

United States, New York

Concorde medical Group, PLLC

New York, New York, United States, 10016

Kips Bay Endoscopy Center

New York, New York, United States, 10016

New York University Langone Medical Center

New York, New York, United States, 10016

NYU Clinical Cancer Center

New York, New York, United States, 10016

NYU Langone Medical Center

New York, New York, United States, 10016

NYU Medical Science Building

New York, New York, United States, 10016

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States, 10021

Weill Cornell Medical College

New York, New York, United States, 10021

New York Presbyterian Hospital-Weill Cornell Medical College

New York, New York, United States, 10065

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, United States, 10065

Weill Cornell Medical College

New York, New York, United States, 10065

University of Rochester Medical Center

Rochester, New York, United States, 14642

United States, North Carolina

UNC Hospitals

Chapel Hill, North Carolina, United States, 27514

UNC Hospitals Endoscopy Center at Meadowmont

Chapel Hill, North Carolina, United States, 27517

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599-7064

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599-7080

United States, Oklahoma

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, United States, 73112

United States, Tennessee

Gastro One

Germantown, Tennessee, United States, 38138

United States, Texas

Parkland Health and Hospital System

Dallas, Texas, United States, 75235

UT Southwestern Medical Center - CRU Aston

Dallas, Texas, United States, 75390-8887

UT Southwestern Medical Center-Clements University Hospital

Dallas, Texas, United States, 75390

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Baylor College of Medicine- Baylor Medical Center

Houston, Texas, United States, 77030

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

Houston, Texas, United States, 77030

Gulf Coast Research Group

Houston, Texas, United States, 77098

Lonestar Endoscopy, LLP

Keller, Texas, United States, 76248

Sagact, Pllc.

San Antonio, Texas, United States, 78229

Sagact, Pllc

San Antonio, Texas, United States, 78229

Lonestar Endoscopy, LLP

Southlake, Texas, United States, 76092

Texas Digestive Disease Consultants

Southlake, Texas, United States, 76092

United States, Virginia

Verity Research

Fairfax, Virginia, United States, 22031

Blue Ridge Medical Research

Lynchburg, Virginia, United States, 24502

McGuire DVAMC

Richmond, Virginia, United States, 23249

United States, Washington

University of Washington

Seattle, Washington, United States, 98195

Austria

AKH Wien Universitaetsklinik fuer Innere Medizin III

Wien, Austria, 1090

Bulgaria

"Medical Center-1- Sevlievo" EOOD

Sevlievo, Gabrovo, Bulgaria, 5400

"MHAT-Blagoevgrad" AD

Blagoevgrad, Bulgaria, 2700

MHAT Dobrich AD

Dobrich, Bulgaria, 9300

MC Hipocrat-2000 OOD

Haskovo, Bulgaria, 6300

MHAT Prof. Dr. Paraskev Stoyanov AD

Lovech, Bulgaria, 5500

Medical Center Vitadar Consult OOD

Ruse, Bulgaria, 7000

SHATPPD dr. Dimitar Gramatikov - Ruse EOOD

Ruse, Bulgaria, 7002

"MC Asklepion - researches in human medicine"" EOOD

Sofia, Bulgaria, 1303

"Acibadem City Clinic UMHAT" EOOD

Sofia, Bulgaria, 1784

Czechia

Hepato-Gastroenterologie HK, s.r.o.

Hradec Kralove, Czechia, 50012

Fakultni nemocnice v Motole

Praha 5, Czechia, 150 06

Nemocnice Slany, p.o.

Slany, Czechia, 274 01

Nemocnice Strakonice, a.s., interni oddeleni

Strakonice, Czechia, 386 01

Denmark

Nordsjaellands Hospital Frederikssund

Frederikssund, Denmark, 3600

Nordsjaellands Hospital Hilleroed

Hilleroed, Denmark, 3400

Amager og Hvidovre Hospital

Hvidovre, Denmark, 2650

Odense Universitetshospital

Odense, Denmark, 5000

Georgia

Research institute of Clinical Medicine

Tbilisi, Georgia, 0112

The First University Clinic of TSMU

Tbilisi, Georgia, 0141

Germany

Paian MED Research GmbH

Berlin, Germany, 10318

Gastrostudien GbR

Berlin, Germany, 10825

Krankenhaus Waldfriede e.V.

Berlin, Germany, 14163

MVZ Dachau - Patientenzentrum

Dachau, Germany, 85221

MVZ Dachau

Dachau, Germany, 85221

Asklepios Westklinikum Hamburg

Hamburg, Germany, 22559

Universitaetsklinikum Schleswig-Holstein

Kiel, Germany, 24105

Eugastro GmbH

Leipzig, Germany, 04103

Hungary

Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz

Bekescsaba, Hungary, 5600

Semmelweis Egyetem, II. Belgyogyaszati Klinika

Budapest, Hungary, 1088

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

Budapest, Hungary, 1125

Pannonia Maganorvosi Centrum

Budapest, Hungary, 1136

Tolna Megyei Balassa Janos Korhaz

Szekszard, Hungary, 7100

Javorszky Odon Korhaz, Gasztroenterologia

Vac, Hungary, 2600

Israel

Clalit Health Services

Bat-Yam, Israel, 5962025

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Diabetes and Endocrinology Unit

Tel Aviv, Israel, 6203854

Migdal Hamea Clinic

Tel Aviv, Israel, 6203854

Italy

IRCCS Saverio De Bellis

Castellana Grotte, Bari, Italy, 70013

AOU Sant'Orsola-Malpighi

Bologna, BO, Italy, 40138

A.O.U. Policlinico G. Martino

Messina, ME, Italy, 98125

Istituto Clinico Humanitas

Rozzano, Milan (MI), Italy, 20089

ASST Rhodense - Ospedale di Circolo di Rho

Rho, Milano (MI), Italy, 20017

Azienda Ospedaliero Universitaria Pisana

Pisa, PI, Italy, 56124

Policlinico Universitario Campus Biomedico

Roma, RM, Italy, 00128

AOU Policlinico di Modena

Modena, Italy, 41124

Azienda Ospedaliera di Padova

Padova, Italy, 35128

Azienda Sanitaria Universitaria Integrata Udine

Udine, Italy, 33100

Korea, Republic of

Kyungpook National University Hospital

Daegu, Korea, Republic of, 41944

Keimyung University Dongsan Hospital

Daegu, Korea, Republic of, 42601

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

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

Seoul, Korea, Republic of, 06591

Poland

SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego w Bialymstoku

Bialystok, Poland, 15-950

ETG Kielce

Kielce, Poland, 25-355

Gastromed Sp. z o.o.

Lublin, Poland, 20-582

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

Poznan, Poland, 61-113

KO-MED Centra Kliniczne Pulawy

Pulawy, Poland, 24-100

ENDOSKOPIA Sp. z o. o.

Sopot, Poland, 81-756

H-T. Centrum Medyczne

Tychy, Poland, 43-100

Centrum Zdrowia MDM

Warszawa, Poland, 00-635

WIP Warsaw IBD Point Profesor Kierkus

Warszawa, Poland, 00-728

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

Wloclawek, Poland, 87-800

Melita Medical Sp z o.o.

Wroclaw, Poland, 50-449

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

Wroclaw, Poland, 51-162

Lexmedica

Wroclaw, Poland, 53-114

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

Wroclaw, Poland, 54-144

Romania

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

Bucuresti, Sector 1,, Romania, 010825

S.C. Cabinet Particular Policlinic Algomed SRL

Timisoara, Timis, Romania, 300002

Spitalul Clinic Colentina, Sectia de Gastroenterologie

Bucuresti, Romania, 020125

Russian Federation

LLC "Olla-Med"

Moscow, Russian Federation, 105554

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

Moscow, Russian Federation, 119435

Limited Liability Company "Medicinsky Center SibNovoMed"

Novosibirsk, Russian Federation, 630005

LLC Novosibirskiy Gastrocentr

Novosibirsk, Russian Federation, 630007

Novosibirskiy Gastrocenter

Novosibirsk, Russian Federation, 630007

Federal State Budgetary Scientific Institution

Novosibirsk, Russian Federation, 630117

FGBOU VO OmGMU Minzdrava Rossii

Omsk, Russian Federation, 644050

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

Rostov-on-Don, Russian Federation, 344022

State Budgetary Institution of Ryazan Region "Regional Clinical Hospital"

Ryazan, Russian Federation, 390039

RIAT Limited Liability Company (RIAT LLC)

Saint-Petersburg, Russian Federation, 195220

Saint-Petersburg State Budgetary Healthcare Institution

Saint-Petersburg, Russian Federation, 195257

Medical University REAVIZ

Samara, Russian Federation, 443011

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

Samara, Russian Federation, 443029

LLC Medical Company Hepatolog

Samara, Russian Federation, 443063

LLC Medical Company Hepatolog

Samara, Russian Federation, 443076

State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital

Yaroslavl, Russian Federation, 150062

Serbia

Clinical Hospital Centre Zvezdara Clinic for Internal Diseases

Belgrade, Serbia, 11000

Clinical Hospital Centre Bezanijska Kosa Clinic for Internal Medicine

Belgrade, Serbia, 11080

Clinical Centre of Kragujevac

Kragujevac, Serbia, 34000

Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology

Nis, Serbia, 18000

General Hospital Subotica

Subotica, Serbia, 24000

Clinical Hospital Center Zemun

Zemun, Belgrade, Serbia, 11080

General Hospital "Djordje Joanovic"

Zrenjanin, Serbia, 23000

Slovakia

Abawi spol. s r.o

Bratislava, Slovakia, 82107

KM Management spol. s.r.o.

Nitra, Slovakia, 949 01

MUDr. Frantisek Horvath Gastroenterologia

Sahy, Slovakia, 936 01

ENDOMED, s.r.o.

Vranov nad Toplou, Slovakia, 093 01

Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain, 39008

Hospital Universitario Fundacion Alcorcon

Alcorcon, Madrid, Spain, 28922

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Madrid, Spain, 28222

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Turkey

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

Ankara, Turkey, 06100

Ankara Universitesi Tip Fakultesi, Ibn-i-Sina Hastanesi

Ankara, Turkey, 06100

Hacettepe Universitesi Tip Fakultesi

Ankara, Turkey, 06230

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

Ankara, Turkey, 06590

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Istanbul, Turkey, 34093

Istanbul Universitesi Istanbul Tıp Fakultesi

Istanbul, Turkey, 34093

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey, 34098

Erciyes Universitesi Tip Fakultesi

Kayseri, Turkey, 38039

Kocaeli Universitesi Tip Fakultesi

Kocaeli, Turkey, 41380

Bulent Ecevit Universitesi Tip Fakultesi

Kozlu Zonguldak, Turkey, 67600

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, Turkey, 33110

Bulent Ecevit Universitesi Tip Fakultesi

Zonguldak, Turkey, 67600

Ukraine

Regional Consultative Polyclinic

Chernivtsi, Ukraine, 58000

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

Chernivtsi, Ukraine, 58001

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

Kharkiv, Ukraine, 61037

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

Kherson, Ukraine, 73000

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

Kropyvnytskyi, Ukraine, 25006

Kyiv Municipal Clinical Hospital #18, Proctology Department

Kyiv, Ukraine, 01030

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

Kyiv, Ukraine, 03680

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

Lviv, Ukraine, 79007

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

Lviv, Ukraine, 79059

Municipal Institution "Odesa Regional Clinical Hospital"

Odesa, Ukraine, 65025

Municipal Institution of Ternopil regional council Ternopil University Hospital

Ternopil, Ukraine, 46002

Municipal Institution "Uzhgorod Regional Hospital"

Uzhgorod, Ukraine, 88009

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

Uzhgorod, Ukraine, 88018

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

Vinnytsia, Ukraine, 21018

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] November 18, 2020

Statistical Analysis Plan  [PDF] May 5, 2021

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02958865
• Other Study ID Numbers: B7981005; VIBRATO ( Other Identifier: Alias Study Number ); 2016-003708-29 ( EudraCT Number )
• First Posted: November 8, 2016
• Results First Posted: July 21, 2022
• Last Update Posted: July 21, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Mayo score

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases; PF-06700841; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action