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Trial record 1 of 1 for:    NCT01831466
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Tofacitinib Ointment For Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01831466
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 28, 2013
First Posted Date  ICMJE April 15, 2013
Results First Submitted Date  ICMJE September 15, 2015
Results First Posted Date  ICMJE November 25, 2015
Last Update Posted Date November 25, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
  • Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]
    Clinical signs of plaque psoriasis (erythema [E], induration [I], and scaling [S]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
  • Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 [ Time Frame: Baseline, Week 8 ]
    Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
  • Calculated Physician Global Assessment (PGA-C) of Psoriasis Score [ Time Frame: Week 12 ]
  • Calculated Physician Global Assessment (PGA-C) of Psoriasis Score [ Time Frame: Week 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
  • Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 [ Time Frame: Week 12 ]
    Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
  • Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 [ Time Frame: Week 8 ]
    Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
  • Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]
    Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.
  • Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 [ Time Frame: Baseline, Week 8 ]
    Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.
  • Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 12 ]
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.
  • Percent Change From Baseline to Week 8 in PASI [ Time Frame: Baseline, Week 8 ]
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.
  • Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.
  • Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 [ Time Frame: Baseline, Week 8 ]
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.
  • Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis [ Time Frame: Baseline, Week 12 ]
    Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.
  • Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis [ Time Frame: Baseline, Week 8 ]
    Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.
  • Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores [ Time Frame: Baseline, Week 12 ]
    The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their "worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "no itching" (0) and "worst possible itching" (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).
  • Change From Baseline to Week 8 in Clinic-Based ISI Scores [ Time Frame: Baseline, Week 8 ]
    The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their "worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "no itching" (0) and "worst possible itching" (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).
  • Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Baseline, Week 12 ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
  • Change From Baseline to Week 8 in the DLQI Total Score [ Time Frame: Baseline, Week 8 ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
  • Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline [ Time Frame: Baseline, Week 12 ]
    The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).
  • Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline [ Time Frame: Baseline, Week 8 ]
    The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
  • Calculated Physician Global Assessment (PGA-C) of Psoriasis Score [ Time Frame: Week 12 ]
  • Calculated Physician Global Assessment (PGA-C) of Psoriasis Score [ Time Frame: Week 8 ]
  • Gestalt Physician's Global Assessment (PGA-G) of Psoriasis Score [ Time Frame: Week 12 ]
  • Gestalt Physician's Global Assessment (PGA-G) of Psoriasis Score [ Time Frame: Week 8 ]
  • Change in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 12 ]
  • Change in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 8 ]
  • Psoriasis Area and Severity Index 75 (PASI75) [ Time Frame: Week 12 ]
  • Psoriasis Area and Severity Index 75 (PASI75) [ Time Frame: Week 8 ]
  • Change in Body Surface Area (BSA) affected with psoriasis [ Time Frame: Baseline, Week 12 ]
  • Change in Body Surface Area (BSA) affected with psoriasis [ Time Frame: Baseline, Week 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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