Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

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NCT02969018

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Study Location
Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
Rogers, Arkansas, 72758, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Plaque Psoriasis
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

- Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)

- Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)

- Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)

- Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
psoriasis, with the exception of nail psoriasis which is allowed


- Have evidence of skin conditions (eg, eczema) at the time of screening or baseline
visit that would interfere with the evaluation of psoriasis


- Cannot discontinue systemic therapies and/or topical therapies for the treatment of
psoriasis and cannot discontinue phototherapy (UVB or PUVA)


- Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).


- Have taken Apremilast (Otezla) within 3 months of first dose of study drug.


- Have undergone treatment with tofacitinib within 3 months of first dose. 

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Chronic Plaque PsoriasisStudy To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis NCT02969018
  1. Rogers, Arkansas
  2. Anaheim, California
  3. Encinitas, California
  4. Sacramento, California
  5. Santa Ana, California
  6. Santa Monica, California
  7. Santa Monica, California
  8. Orange Park, Florida
  9. Orange Park, Florida
  10. Tampa, Florida
  11. Tampa, Florida
  12. Tampa, Florida
  13. West Dundee, Illinois
  14. Indianapolis, Indiana
  15. Indianapolis, Indiana
  16. East Windsor, New Jersey
  17. New York, New York
  18. Rochester, New York
  19. Chapel Hill, North Carolina
  20. Chapel Hill, North Carolina
  21. Chapel Hill, North Carolina
  22. Oklahoma City, Oklahoma
  23. Tulsa, Oklahoma
  24. Rapid City, South Dakota
  25. Houston, Texas
  26. San Antonio, Texas
  27. San Antonio, Texas
  28. San Antonio, Texas
  29. Norfolk, Virginia
  30. Spokane, Washington
  31. Winnipeg, Manitoba
  32. Markham, Ontario
  33. Oakville, Ontario
  34. Peterborough, Ontario
  35. Richmond Hill, Ontario
  36. Waterloo, Ontario
  37. Sherbrooke, Quebec
  38. Quebec,
  39. Gdansk,
  40. Gdansk,
  41. Lodz,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Official Title  ICMJE A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Brief Summary The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Plaque Psoriasis
Intervention  ICMJE
  • Drug: PF-06700841
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: PF-06700841 60 mg followed by 30 mg once daily
    4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 60 mg followed by 10 mg once daily
    4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 60mg once daily followed by 100mg once weekly
    4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 60mg once daily followed by placebo once daily
    4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 30mg once daily
    4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 30mg once daily followed by 10mg once daily
    4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 30mg once daily followed by 100mg once weekly
    4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
    Intervention: Drug: PF-06700841
  • Placebo Comparator: Placebo
    12 weeks once daily placebo
    Intervention: Other: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2018)		212
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2016)		200
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
  • Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
  • Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
  • Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:

  • Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
  • Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
  • Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
  • Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
  • Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
  • Have undergone treatment with tofacitinib within 3 months of first dose.
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 Canada,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02969018
Other Study ID Numbers  ICMJE B7931004
2016-004049-96 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 March 2019

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