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

NCT02958865

Last updated date
Study Location
MUNICIPAL NON-COMMERCIAL ENTERPRISE CITY CLINICAL HOSPITAL No.2 n.a. PROF O.O. SHALIMOV of KHARKIV
Kharkiv, , 61037, Ukraine
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of ulcerative colitis for greater than/equal to 4 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnant or breastfeeding


- Clinical findings suggestive of Crohn's Disease


- History of bowel surgery within 6 months

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Duration
The time commitment for participation in the study.
Follow up: 4 weeks
Screening: Up to 6 weeks
Treatment: 32 weeks
Site Visits
Follow up: 1 visits
Screening: Up to 2 visits
Treatment: 9 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Questionnaire
Keeping a diary
Stool test
Physical examination
Electrocardiogram (ECG)
Biopsy
Urine test
Colonoscopy
Vital signs and measurements
X-rays

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Advanced Information
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 29, 2020)
318
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2016)
360
Estimated Study Completion Date  ICMJE May 10, 2021
Estimated Primary Completion Date May 10, 2021   (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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bulgaria,   Czechia,   Denmark,   Georgia,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Turkey,   Ukraine,   United States
Removed Location Countries Canada,   Netherlands
 
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2020

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