Tofacitinib Ointment For Chronic Plaque Psoriasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01831466
First received: March 28, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis Vulgaris
Psoriasis
Drug: tofacitinib ointment 20 mg/g
Drug: tofacitinib ointment 10 mg/g
Drug: placebo ointment (vehicle)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Calculated Physician Global Assessment (PGA-C) of Psoriasis Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    For participants with baseline PGA-C score of Mild (2) or Moderate (3), the proportion of participants achieving a PGA-C response of clear (0) or almost clear

    (1) and a minimum of 2 grade/point improvement from baseline at week 12.


  • Calculated Physician Global Assessment (PGA-C) of Psoriasis Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    For participants with baseline PGA-C score of Mild (2) or Moderate (3), the proportion of participants achieving a PGA-C response of clear (0) or almost clear

    (1) and a minimum of 2 grade/point improvement from baseline at week 8.



Secondary Outcome Measures:
  • Calculated Physician Global Assessment (PGA-C) of Psoriasis Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    For participants with baseline PGA-C score of Mild (2) or Moderate (3), the proportion of participants achieving a PGA-C response of clear (0) or almost clear

    (1) at Week 12


  • Calculated Physician Global Assessment (PGA-C) of Psoriasis Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    For participants with baseline PGA-C score of Mild (2) or Moderate (3), the proportion of participants achieving a PGA-C response of clear (0) or almost clear

    (1) at Week 8


  • Gestalt Physician's Global Assessment (PGA-G) of Psoriasis Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    For participants with baseline PGA-C score of Mild (2) or Moderate (3), PGA-G response of clear (0) or almost clear (1) and a minimum of 2 grade/point improvement from baseline at Week 12

  • Gestalt Physician's Global Assessment (PGA-G) of Psoriasis Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    For participants with baseline PGA-C score of Mild (2) or Moderate (3), PGA-G response of clear (0) or almost clear (1) and a minimum of 2 grade/point improvement from baseline at Week 8

  • Change in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    For participants with baseline PGA-C score of Mild (2) or Moderate (3), percent change from baseline in Psoriasis Area and Severity Index (PASI) at Week 12

  • Change in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    For participants with baseline PGA-C score of Mild (2) or Moderate (3), percent change from baseline in Psoriasis Area and Severity Index (PASI) at Week 8

  • Psoriasis Area and Severity Index 75 (PASI75) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    For participants with baseline PGA-C score of Mild (2) or Moderate (3), Psoriasis Area and Severity Index 75 (PASI75) response, ie, the proportion of participants achieving at least a 75% reduction in PASI relative to baseline at Week 12

  • Psoriasis Area and Severity Index 75 (PASI75) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    For participants with baseline PGA-C score of Mild (2) or Moderate (3), Psoriasis Area and Severity Index 75 (PASI75) response, ie, the proportion of participants achieving at least a 75% reduction in PASI relative to baseline at Week 8

  • Change in Body Surface Area (BSA) affected with psoriasis [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    For participants with baseline PGA-C score of Mild (2) or Moderate (3), the percent change from baseline in Body Surface Area (BSA) affected with psoriasis at Week 12

  • Change in Body Surface Area (BSA) affected with psoriasis [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    For participants with baseline PGA-C score of Mild (2) or Moderate (3), the percent change from baseline in Body Surface Area (BSA) affected with psoriasis at Week 8


Estimated Enrollment: 480
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A Drug: tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
Experimental: Treatment Group B Drug: tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
Placebo Comparator: Treatment Group C Drug: placebo ointment (vehicle)
placebo ointment (vehicle) BID (twice daily) for 12 weeks
Experimental: Treatment Group D Drug: tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
Experimental: Treatment Group E Drug: tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
Placebo Comparator: Treatment Group F Drug: placebo ointment (vehicle)
placebo ointment (vehicle) QD (once daily) for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831466

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 66 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01831466     History of Changes
Other Study ID Numbers: A3921082
Study First Received: March 28, 2013
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
plaque psoriasis
psoriasis
nail psoriasis
vulgaris
topical treatment
skin diseases
papulosquamous
Tofacitinib
CP-690550
Xeljanz
moderate
severe
itch

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014