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

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ClinicalTrials.gov Identifier: NCT02958865
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 4, 2016
First Posted Date  ICMJE November 8, 2016
Last Update Posted Date October 9, 2019
Actual Study Start Date  ICMJE February 3, 2017
Estimated Primary Completion Date December 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
Change from baseline in Total Mayo Score [ Time Frame: Baseline and Week 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02958865 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Proportion of subjects achieving remission based on total Mayo score [ Time Frame: Week 8 ]
    Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 at Week 8.
  • Proportion of subjects in remission based on total Mayo score [ Time Frame: Week 32 ]
    Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 at week 32.
  • Proportion of subjects achieving improvement in endoscopic appearance [ Time Frame: Week 8 and 32 ]
    Improvement of endoscopic appearance is defined as a Mayo endoscopic subscore of less than/equal to 1
  • Proportion of subjects achieving clinical response [ Time Frame: Week 8 ]
    Clinical response is defined as a 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.
  • Proportion of subjects in endoscopic remission [ Time Frame: Week 8 ]
    Endoscopic remission is defined as an endoscopic subscore of 0.
  • Proportion of subjects in symptomatic remission [ Time Frame: Week 8 ]
    Symptomatic remission is defined as a 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.
  • Proportion of subjects achieving deep remission [ Time Frame: Week 8 ]
    Deep remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a 0 on both endoscopic and rectal bleeding subscores.
  • Partial Mayo Scores and changes from baseline [ Time Frame: Weeks 2, 4 and 8 ]
  • Change from baseline in total Mayo score [ Time Frame: Week 8 ]
  • Change from baseline in total Mayo score [ Time Frame: Week 32 ]
  • Scores and changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score and domains [ Time Frame: Weeks 4 and 8 ]
    IBDQ domains include Bowel Symptoms, Systemic Symptoms, Emotional Function and Social Function.
  • Proportion of subjects with IBDQ total score greater than/equal to 170. [ Time Frame: Weeks 4 and 8 ]
  • Proportion of subjects with greater than/equal to 16 point increase in IBDQ total score from baseline [ Time Frame: Weeks 4 and 8 ]
  • Proportion of subjects with improvement in IBDQ bowel symptom domain [ Time Frame: Weeks 4 and 8 ]
    Improvement is defined as an increase of at least 1.2 points from baseline in average score among IBDQ bowel symptom domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).
  • Scores and changes from baseline in SF-36 v2 [ Time Frame: Weeks 4 and 8 ]
    SF-36 physical and mental component summary scores: PCS and MCS, and 8 domain scores.
  • Scores and changes from baseline in EuroQoL-5 Dimensions [ Time Frame: Weeks 4 and 8 ]
  • Incidence of serious infections [ Time Frame: Baseline through week 36 ]
    Serious infections are treated infections that require parenteral antimicrobial therapy and present with positive pre-treatment culture AND EITHER require hospitalization for treatment OR meet other criteria that require the infection to be classified as an SAE.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • Proportion of subjects achieving remission based on total Mayo score [ Time Frame: Week 8 ]
    Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 at Week 8.
  • Proportion of subjects in remission based on total Mayo score [ Time Frame: Week 32 ]
    Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 at week 32.
  • Proportion of subjects achieving improvement in endoscopic appearance [ Time Frame: Week 8 ]
    Improvement of endoscopic appearance is defined as a Mayo endoscopic subscore of less than/equal to 1
  • Proportion of subjects achieving clinical response [ Time Frame: Week 8 ]
    Clinical response is defined as a 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.
  • Proportion of subjects in endoscopic remission [ Time Frame: Week 8 ]
    Endoscopic remission is defined as an endoscopic subscore of 0.
  • Proportion of subjects in symptomatic remission [ Time Frame: Week 8 ]
    Symptomatic remission is defined as a 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.
  • Proportion of subjects achieving deep remission [ Time Frame: Week 8 ]
    Deep remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a 0 on both endoscopic and rectal bleeding subscores.
  • Partial Mayo Scores and changes from baseline [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, and 32 ]
  • Change from baseline in total Mayo score [ Time Frame: Week 8 ]
  • Change from baseline in total Mayo score [ Time Frame: Week 32 ]
  • Scores and changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score and domains [ Time Frame: Weeks 4, 8, and 32 ]
    IBDQ domains include Bowel Symptoms, Systemic Symptoms, Emotional Function and Social Function.
  • Proportion of subjects with IBDQ total score greater than/equal to 170. [ Time Frame: Weeks 4, 8, and 32 ]
  • Proportion of subjects with greater than/equal to 16 point increase in IBDQ total score from baseline [ Time Frame: Weeks 4, 8, and 32 ]
  • Proportion of subjects with improvement in IBDQ bowel symptom domain [ Time Frame: Weeks 4, 8, and 32 ]
    Improvement is defined as an increase of at least 1.2 points from baseline in average score among IBDQ bowel symptom domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).
  • Scores and changes from baseline in SF-36 v2 [ Time Frame: Weeks 4, 8, and 32 ]
    SF-36 physical and mental component summary scores: PCS and MCS, and 8 domain scores.
  • Scores and changes from baseline in EuroQoL-5 Dimensions [ Time Frame: Weeks 4, 8, and 32 ]
  • Incidence of serious infections [ Time Frame: Baseline through week 36 ]
    Serious infections are treated infections that require parenteral antimicrobial therapy and present with positive pre-treatment culture AND EITHER require hospitalization for treatment OR meet other criteria that require the infection to be classified as an SAE.
  • Proportion of subjects achieving improvement in endoscopic appearance [ Time Frame: Week 32 ]
    Improvement of endoscopic appearance is defined as a Mayo endoscopic subscore of less than/equal to 1
  • Proportion of subjects achieving clinical response [ Time Frame: Week 32 ]
    Clinical response is defined as a 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.
  • Proportion of subjects in endoscopic remission [ Time Frame: Week 32 ]
    Endoscopic remission is defined as an endoscopic subscore of 0.
  • Proportion of subjects in symptomatic remission [ Time Frame: Week 32 ]
    Symptomatic remission is defined as a 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.
  • Proportion of subjects achieving deep remission [ Time Frame: Week 32 ]
    Deep remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a 0 on both endoscopic and rectal bleeding subscores.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: PF-06651600 or Placebo
    Delivered orally for 8 weeks.
  • Drug: PF-06700841 or Placebo
    Delivered orally for 8 weeks.
  • Drug: PF-06700841
    Delivered orally for 24 weeks.
  • Drug: PF-06651600
    Delivered orally for 24 weeks.
Study Arms  ICMJE
  • Experimental: PF-06651600 Drug Dose Level 1
    Delivered orally for 8 weeks
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: PF-06651600 Drug Dose Level 2
    Delivered orally for 8 weeks
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: PF-06651600 Drug Dose Level 3
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06651600 or Placebo
  • Placebo Comparator: PF-06651600 Placebo
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: PF-06700841 Drug Dose Level 1
    Delivered orally for 8 weeks
    Intervention: Drug: PF-06700841 or Placebo
  • Experimental: PF-06700841 Drug Dose Level 2
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06700841 or Placebo
  • Experimental: PF-06700841 Drug Dose Level 3
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06700841 or Placebo
  • Placebo Comparator: PF-06700841 Placebo
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06700841 or Placebo
  • Experimental: PF-06651600 Drug Dose Level 4
    Delivered orally for 24 weeks.
    Intervention: Drug: PF-06651600
  • Experimental: PF-06700841 Drug Dose Level 4
    Delivered orally for 24 weeks.
    Intervention: Drug: PF-06700841
Publications * Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2016)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 19, 2021
Estimated Primary Completion Date December 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Austria,   Bulgaria,   Canada,   Czechia,   Denmark,   Georgia,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02958865
Other Study ID Numbers  ICMJE B7981005
VIBRATO ( Other Identifier: Alias Study Number )
2016-003708-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP