A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis

Back to Search
Print
Bookmark Trial

NCT03895372

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, 85260, 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:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

- Male or female between the ages of 18 and 75 years.

- Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.

- Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).

- Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

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


- Have non-plaque forms of psoriasis.


- Drug-induced psoriasis.


- Current active infection.


- Infected with Mycobacterium tuberculosis (TB).


- Have any history of malignancies.


- Require treatment with prohibited concomitant medications(s).


- Positive for hepatitis B or C, or human immunodeficiency virus (HIV).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

PsoriasisStudy Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept
NCT00992394
  1. Besancon,
  2. Limoges,
  3. Lyon Cedex 03,
  4. Nantes Cedex 01,
  5. Nice Cedex 03,
  6. Paris,
  7. Pierre Benite,
  8. Poitiers,
  9. Reims,
  10. Toulouse Cedex,
  11. Berlin,
  12. Bochum,
  13. Erlangen,
  14. Frankfurt am Main,
  15. Freiburg,
  16. Hamburg,
  17. Osnabrueck,
  18. Athens,
  19. Thessaloniki,
  20. Budapest,
  21. Debrecen,
  22. Miskolc,
  23. Szeged,
  24. Catania,
  25. Chieti,
  26. Parma,
  27. Santander, Cantabria
  28. Alcorcon, Madrid
  29. Getafe, Madrid
  30. Alicante,
  31. Madrid,
  32. Malaga,
  33. Istanbul, Capa
  34. Ankara, Etlik
  35. Ankara, Etlik
  36. Ankara, Etlik
  37. Istanbul, Fatih
  38. Bursa, Gorukle
  39. Pendik, Istanbul
  40. Ankara, Sihhiye
  41. Ankara, Sihhiye
  42. Ankara,
  43. Bornova / Izmir,
  44. Abu Dhabi, UAE
  45. Harrogate,
  46. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
PsoriasisEffectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT00678210
  1. Tucson, Arizona
  2. Little Rock, Arkansas
  3. Oceanside, California
  4. Jacksonville, Florida
  5. Miami, Florida
  6. West Dundee, Illinois
  7. Boston, Massachusetts
  8. Boston, Massachusetts
  9. Worcester, Massachusetts
  10. Saint Louis, Missouri
  11. East Windsor, New Jersey
  12. Paramus, New Jersey
  13. New York, New York
  14. Rochester, New York
  15. Winston Salem, North Carolina
  16. Cleveland, Ohio
  17. Norman, Oklahoma
  18. Lake Oswego, Oregon
  19. Portland, Oregon
  20. Portland, Oregon
  21. Philadelphia, Pennsylvania
  22. Greer, South Carolina
  23. Greer, South Carolina
  24. Mt. Pleasant, South Carolina
  25. Dallas, Texas
  26. Houston, Texas
  27. Webster, Texas
  28. Salt Lake City, Utah
  29. Norfolk, Virginia
  30. Vancouver, British Columbia
  31. Moncton, New Brunswick
  32. St. John's, Newfoundland and Labrador
  33. Halifax, Nova Scotia
  34. Halifax, Nova Scotia
  35. Halifax, Nova Scotia
  36. Barrie, Ontario
  37. London, Ontario
  38. North Bay, Ontario
  39. Waterloo, Ontario
  40. Windsor, Ontario
  41. Laval, Quebec
  42. Montreal, Quebec
  43. Montreal, Quebec
  44. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
PsoriasisTopical CP-690,550 For Chronic Plaque Psoriasis
NCT00678561
  1. Irvine, California
  2. San Diego, California
  3. Chicago, Illinois
  4. Boston, Massachusetts
  5. Ann Arbor, Michigan
  6. Fridley, Minnesota
  7. Saint Louis, Missouri
  8. High Point, North Carolina
  9. WinstoN Salem, North Carolina
  10. Portland, Oregon
  11. Portland, Oregon
  12. Austin, Texas
  13. Salt Lake City, Utah
  14. Surrey, British Columbia
  15. St. John's, Newfoundland and Labrador
  16. Waterloo, Ontario
  17. Montreal, Quebec
  18. Montreal, Quebec
  19. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
PsoriasisA One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
NCT01276639
  1. Birmingham, Alabama
  2. Irvine, California
  3. San Diego, California
  4. Santa Monica, California
  5. Denver, Colorado
  6. New Haven, Connecticut
  7. Ocala, Florida
  8. Tampa, Florida
  9. Alpharetta, Georgia
  10. Atlanta, Georgia
  11. Newnan, Georgia
  12. Springfield, Illinois
  13. Indianapolis, Indiana
  14. Boston, Massachusetts
  15. Boston, Massachusetts
  16. Omaha, Nebraska
  17. New York, New York
  18. Rochester, New York
  19. Raleigh, North Carolina
  20. Raleigh, North Carolina
  21. Norman, Oklahoma
  22. Lake Oswego, Oregon
  23. Pittsburgh, Pennsylvania
  24. Johnston, Rhode Island
  25. Knoxville, Tennessee
  26. Dallas, Texas
  27. Dallas, Texas
  28. Houston, Texas
  29. Spokane, Washington
  30. Spokane, Washington
  31. Wenatchee, Washington
  32. Madison, Wisconsin
  33. Winnipeg, Manitoba
  34. St. John's, Newfoundland and Labrador
  35. Halifax, Nova Scotia
  36. Barrie, Ontario
  37. Markham, Ontario
  38. North Bay, Ontario
  39. Oakville, Ontario
  40. Ottawa, Ontario
  41. Waterloo, Ontario
  42. Quebec,
  43. Barranquilla, Atlantico
  44. Bogot, Cundinamarca
  45. Berlin,
  46. Berlin,
  47. Bonn,
  48. Dresden,
  49. Hamburg,
  50. Kiel,
  51. Muenster,
  52. Schwerin,
  53. Vechta,
  54. Wuppertal,
  55. Kecskemet,
  56. Nyiregyhaza,
  57. Pecs,
  58. Maebashi-shi, Gunma
  59. Sapporo, Hokkaido
  60. Chuo-ku, Kobe
  61. Kumamoto-shi, Kumamoto
  62. Shinjyuku-ku, Tokyo
  63. Monterrey, Nuevo Leon
  64. Poznan,
  65. Szczecin,
  66. Wroclaw,
  67. Wroclaw,
  68. Belgrade,
  69. Tainan,
  70. Taipei,
  71. Simferopol, Crimea
  72. Kharkiv,
  73. Kyiv,
  74. Ternopil,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis
Official Title  ICMJE A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Brief Summary This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.
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 Psoriasis
Intervention  ICMJE
  • Drug: PF-06826647 or Placebo
    Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
  • Drug: PF-06826647
    Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
Study Arms  ICMJE
  • Experimental: PF-06826647 Drug Dose Level 1
    Delivered orally for 16 weeks during the Investigational Treatment Period
    Intervention: Drug: PF-06826647 or Placebo
  • Experimental: PF-06826647 Placebo
    Delivered orally for 16 weeks during the Investigational Treatment Period
    Intervention: Drug: PF-06826647 or Placebo
  • Experimental: PF-06826647 Drug Dose Level 2
    Delivered orally for 16 weeks during the Investigational Treatment Period
    Intervention: Drug: PF-06826647 or Placebo
  • Experimental: PF-06826647 Drug Dose Level 3
    Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.
    Interventions:
    • Drug: PF-06826647 or Placebo
    • Drug: PF-06826647
  • Experimental: PF-06826647 Drug Dose Level 4
    Delivered orally for 16 weeks then for 24 weeks in Extension Period.
    Interventions:
    • Drug: PF-06826647 or Placebo
    • Drug: PF-06826647
Publications * Not Provided

*   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: March 27, 2019)		160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 3, 2020
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female between the ages of 18 and 75 years.
  • Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.
  • Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).
  • Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

Exclusion Criteria:

  • Have non-plaque forms of psoriasis.
  • Drug-induced psoriasis.
  • Current active infection.
  • Infected with Mycobacterium tuberculosis (TB).
  • Have any history of malignancies.
  • Require treatment with prohibited concomitant medications(s).
  • Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
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 Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Canada,   Japan,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03895372
Other Study ID Numbers  ICMJE C2501004
2018-004669-16 ( 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:No
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….
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 June 2020

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