Tofacitinib Ointment For Chronic Plaque Psoriasis

NCT01831466

Last updated date
Study Location
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Contact
1-800-718-1021

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

- Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline

- At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails)

- If received certain treatments, should be off treatment for a minimum period of time (washout)

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 or drug-induced psoriasis


- Require treatment with or cannot stop medication(s) prohibited during the study


- Have certain laboratory abnormalities at Baseline


- Current or history of certain infections


- Females who are pregnant, breastfeeding, or are of childbearing potential not using
highly effective contraception

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Psoriasis Vulgaris, PsoriasisTofacitinib Ointment For Chronic Plaque Psoriasis
NCT01831466
  1. Hot Springs, Arkansas
  2. Bakersfield, California
  3. Irvine, California
  4. Los Angeles, California
  5. Orange Park, Florida
  6. Tampa, Florida
  7. Alpharetta, Georgia
  8. Atlanta, Georgia
  9. Newnan, Georgia
  10. West Dundee, Illinois
  11. Boston, Massachusetts
  12. Boston, Massachusetts
  13. Clinton Township, Michigan
  14. High Point, North Carolina
  15. Winston-Salem, North Carolina
  16. Cincinnati, Ohio
  17. Portland, Oregon
  18. Portland, Oregon
  19. Johnston, Rhode Island
  20. Providence, Rhode Island
  21. Greer, South Carolina
  22. Rapid City, South Dakota
  23. Nashville, Tennessee
  24. Arlington, Texas
  25. Dallas, Texas
  26. Dallas, Texas
  27. Houston, Texas
  28. San Antonio, Texas
  29. San Antonio, Texas
  30. Edmonton, Alberta
  31. Winnipeg, Manitoba
  32. Ajax, Ontario
  33. Barrie, Ontario
  34. Hamilton, Ontario
  35. London, Ontario
  36. Markham, Ontario
  37. Peterborough, Ontario
  38. Waterloo, Ontario
  39. Windsor, Ontario
  40. Montreal, Quebec
  41. Montreal, Quebec
  42. Aarhus C,
  43. Herning,
  44. Warszawa, Mazowieckie
  45. Poznan, Wielkopolskie
  46. Bialystok,
  47. Bialystok,
  48. Gdansk,
  49. Krakow,
  50. Lublin,
  51. Poznan,
  52. Warszawa 44,
  53. Warszawa,
  54. Wroclaw,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Tofacitinib Ointment For Chronic Plaque Psoriasis
Official Title  ICMJE A Phase 2b, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Efficacy, Safety, Local Tolerability And Pharmacokinetics Of 2 Dose Strengths And 2 Regimens Of Tofacitinib Ointment In Subjects With Chronic Plaque Psoriasis.
Brief Summary The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.
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
  • Psoriasis Vulgaris
  • Psoriasis
Intervention  ICMJE
  • Drug: tofacitinib ointment 20 mg/g
    tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
  • Drug: tofacitinib ointment 10 mg/g
    tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
  • Drug: placebo ointment (vehicle)
    placebo ointment (vehicle) BID (twice daily) for 12 weeks
  • Drug: tofacitinib ointment 20 mg/g
    tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
  • Drug: tofacitinib ointment 10 mg/g
    tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
  • Drug: placebo ointment (vehicle)
    placebo ointment (vehicle) QD (once daily) for 12 weeks
Study Arms  ICMJE
  • Experimental: Treatment Group A
    Intervention: Drug: tofacitinib ointment 20 mg/g
  • Experimental: Treatment Group B
    Intervention: Drug: tofacitinib ointment 10 mg/g
  • Placebo Comparator: Treatment Group C
    Intervention: Drug: placebo ointment (vehicle)
  • Experimental: Treatment Group D
    Intervention: Drug: tofacitinib ointment 20 mg/g
  • Experimental: Treatment Group E
    Intervention: Drug: tofacitinib ointment 10 mg/g
  • Placebo Comparator: Treatment Group F
    Intervention: Drug: placebo ointment (vehicle)
Publications * Papp KA, Bissonnette R, Gooderham M, Feldman SR, Iversen L, Soung J, Draelos Z, Mamolo C, Purohit V, Wang C, Ports WC. Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial. BMC Dermatol. 2016 Oct 3;16(1):15.

*   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: November 26, 2014)
476
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2013)
480
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline
  • At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails)
  • If received certain treatments, should be off treatment for a minimum period of time (washout)

Exclusion Criteria:

  • Currently have non-plaque forms of psoriasis or drug-induced psoriasis
  • Require treatment with or cannot stop medication(s) prohibited during the study
  • Have certain laboratory abnormalities at Baseline
  • Current or history of certain infections
  • Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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,   Denmark,   Poland,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT01831466
Other Study ID Numbers  ICMJE A3921082
2012-005645-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 October 2015

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