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CompletedNCT01831466Updated Nov 25, 2015Results posted

Tofacitinib Ointment For Chronic Plaque Psoriasis

A Phase 2 interventional study of tofacitinib ointment 20 mg/g and tofacitinib ointment 10 mg/g in Psoriasis Vulgaris and Psoriasis, sponsored by Pfizer. Completed at 54 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-25.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
476
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis Vulgaris
  • Psoriasis

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Keywords

  • plaque psoriasis
  • vulgaris
  • topical treatment
  • skin diseases
  • papulosquamous
  • Tofacitinib
  • CP-690550
  • Xeljanz
  • psoriasis
  • moderate
  • severe
  • itch
  • nail psoriasis
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 476 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
476 participants (actual)

Study arms

  • Experimental
    Treatment Group A

    Drug: tofacitinib ointment 20 mg/g

  • Experimental
    Treatment Group B

    Drug: tofacitinib ointment 10 mg/g

  • Placebo comparator
    Treatment Group C

    Drug: placebo ointment (vehicle)

  • Experimental
    Treatment Group D

    Drug: tofacitinib ointment 20 mg/g

  • Experimental
    Treatment Group E

    Drug: tofacitinib ointment 10 mg/g

  • Placebo comparator
    Treatment Group F

    Drug: placebo ointment (vehicle)

Interventions

  • Drugtofacitinib ointment 20 mg/g

    tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks

  • Drugtofacitinib ointment 10 mg/g

    tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks

  • Drugplacebo ointment (vehicle)

    placebo ointment (vehicle) BID (twice daily) for 12 weeks

  • Drugtofacitinib ointment 20 mg/g

    tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks

  • Drugtofacitinib ointment 10 mg/g

    tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks

  • Drugplacebo ointment (vehicle)

    placebo ointment (vehicle) QD (once daily) for 12 weeks

06

What researchers measure

Primary outcomes

  1. 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

    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.

    Time frame: Baseline, Week 12

  2. 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

    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.

    Time frame: Baseline, Week 8

Secondary outcomes

  1. Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at 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.

    Time frame: Week 12

  2. Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at 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.

    Time frame: Week 8

  3. 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

    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.

    Time frame: Baseline, Week 12

  4. 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

    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.

    Time frame: Baseline, Week 8

  5. Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)

    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.

    Time frame: Baseline, Week 12

  6. Percent Change From Baseline to Week 8 in PASI

    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.

    Time frame: Baseline, Week 8

  7. Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at 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.

    Time frame: Baseline, Week 12

  8. Percentage of Participants Achieving PASI75, Relative to Baseline at 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.

    Time frame: Baseline, Week 8

  9. Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis

    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.

    Time frame: Baseline, Week 12

  10. Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis

    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.

    Time frame: Baseline, Week 8

  11. Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores

    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).

    Time frame: Baseline, Week 12

  12. Change From Baseline to Week 8 in Clinic-Based ISI Scores

    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).

    Time frame: Baseline, Week 8

  13. Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score

    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.

    Time frame: Baseline, Week 12

  14. Change From Baseline to Week 8 in the DLQI Total Score

    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.

    Time frame: Baseline, Week 8

  15. 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

    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).

    Time frame: Baseline, Week 12

  16. 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

    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).

    Time frame: Baseline, Week 8

07

Results

Posted Nov 25, 2015
Limitations and caveats
Efficacy results for participants in the severe population were not reported since this was considered an exploratory population.

Participant flow

Participants with mild (PGA-C score of 2), moderate (PGA-C score of 3), or severe (PGA-C score of 4) chronic plaque psoriasis were recruited for this study. The primary analysis population for this study included only the participants with mild and moderate disease.

Participant flow — Overall Study
MilestoneMild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)Mild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)Mild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QDSevere: Tofacitinib 20 mg/g BIDSevere: Tofacitinib 10 mg/g BIDSevere: Placebo (Vehicle) BIDSevere: Tofacitinib 20 mg/g QDSevere: Tofacitinib 10 mg/g QDSevere: Placebo (Vehicle) QD
Started717071707474777767
Completed555248515748654243
Not completed161823191726123524
Withdrew: Protocol violation112001000000
Withdrew: Other232221000000
Withdrew: Non-compliance with study treatment211001000000
Withdrew: Death010000000000
Withdrew: Withdrawal by subject633335000101
Withdrew: Lost to follow-up014203000101
Withdrew: Lack of efficacy587698112220
Withdrew: Adverse event004637011102

Outcome measures

PrimaryPercentage 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

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.

Time frame:
Baseline, Week 12
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
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 1221.112.916.920.021.617.6
Statistical analysis
  • Mild/Moderate: Tofacitinib 20 mg/g BID vs Mild/Moderate: Placebo (Vehicle) BID · Cochran-Mantel-Haenszel · p = 0.5425 · Difference in response rates: 3.9 · 80% CI -4.3 to 12.0
  • Mild/Moderate: Tofacitinib 10 mg/g BID vs Mild/Moderate: Placebo (Vehicle) BID · Cochran-Mantel-Haenszel · p = 0.4976 · Difference in response rates: -4.0 · 80% CI -11.5 to 3.5
  • Mild/Moderate: Tofacitinib 20 mg/g QD vs Mild/Moderate: Placebo (Vehicle) QD · Cochran-Mantel-Haenszel · p = 0.6039 · Difference in response rates: 3.3 · 80% CI -4.9 to 11.5
  • Mild/Moderate: Tofacitinib 10 mg/g QD vs Mild/Moderate: Placebo (Vehicle) QD · Cochran-Mantel-Haenszel · p = 0.5279 · Difference in response rate: 4.0 · 80% CI -4.1 to 12.1
PrimaryPercentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at 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.

Time frame:
Baseline, Week 8
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 822.510.011.318.614.98.1
Statistical analysis
  • Mild/Moderate: Tofacitinib 20 mg/g BID vs Mild/Moderate: Placebo (Vehicle) BID · Cochran-Mantel-Haenszel · p = 0.0710 · Difference in response rates: 10.8 · 80% CI 3.1 to 18.5
  • Mild/Moderate: Tofacitinib 10 mg/g BID vs Mild/Moderate: Placebo (Vehicle) BID · Cochran-Mantel-Haenszel · p = 0.8175 · Difference in response rates: -1.2 · 80% CI -7.9 to 5.5
  • Mild/Moderate: Tofacitinib 20 mg/g QD vs Mild/Moderate: Placebo (Vehicle) QD · Cochran-Mantel-Haenszel · p = 0.0513 · Difference in response rates: 11.0 · 80% CI 3.8 to 18.2
  • Mild/Moderate: Tofacitinib 10 mg/g QD vs Mild/Moderate: Placebo (Vehicle) QD · Cochran-Mantel-Haenszel · p = 0.2021 · Difference in response rates: 6.7 · 80% CI -0.0 to 13.4
SecondaryPercentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at 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.

Time frame:
Week 12
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 1233.825.723.927.129.723.0
SecondaryPercentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at 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.

Time frame:
Week 8
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 836.620.022.532.921.612.2
SecondaryPercentage 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

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.

Time frame:
Baseline, Week 12
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
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 1218.311.414.115.718.912.2
SecondaryPercentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at 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.

Time frame:
Baseline, Week 8
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 821.17.111.315.79.54.1
SecondaryPercent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · Percent Change from Baseline
Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
Percent Change from BaselineMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)-36.6 ± 40.88-35.7 ± 43.78-32.0 ± 49.47-38.6 ± 36.37-31.4 ± 42.36-30.0 ± 38.68
SecondaryPercent Change From Baseline to Week 8 in PASI

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.

Time frame:
Baseline, Week 8
Reported as:
Mean · Percent Change from Baseline
Percent Change From Baseline to Week 8 in PASI
Percent Change from BaselineMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percent Change From Baseline to Week 8 in PASI-36.7 ± 36.01-29.1 ± 40.86-28.8 ± 37.06-36.5 ± 33.87-29.0 ± 29.47-27.1 ± 32.93
SecondaryPercentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at 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.

Time frame:
Baseline, Week 12
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 1216.912.912.715.710.86.8
SecondaryPercentage of Participants Achieving PASI75, Relative to Baseline at 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.

Time frame:
Baseline, Week 8
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percentage of Participants Achieving PASI75, Relative to Baseline at Week 814.18.67.015.76.86.8
SecondaryPercent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · Percent Change from Baseline
Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis
Percent Change from BaselineMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis-32.8 ± 40.92-27.5 ± 36.40-27.7 ± 43.43-24.6 ± 36.29-15.6 ± 36.63-11.2 ± 56.38
SecondaryPercent Change From Baseline to Week 8 in BSA Affected With Psoriasis

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.

Time frame:
Baseline, Week 8
Reported as:
Mean · Percent Change from Baseline
Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis
Percent Change from BaselineMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis-25.4 ± 44.75-22.5 ± 35.87-20.5 ± 34.90-17.8 ± 28.59-9.0 ± 30.08-11.7 ± 38.29
SecondaryChange From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores

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).

Time frame:
Baseline, Week 12
Reported as:
Mean · Score on a Scale
Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores
Score on a ScaleMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores-2.88 ± 3.140-2.89 ± 3.320-1.73 ± 2.460-2.38 ± 3.182-1.94 ± 3.151-1.50 ± 2.961
SecondaryChange From Baseline to Week 8 in Clinic-Based ISI Scores

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).

Time frame:
Baseline, Week 8
Reported as:
Mean · Score on a Scale
Change From Baseline to Week 8 in Clinic-Based ISI Scores
Score on a ScaleMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Change From Baseline to Week 8 in Clinic-Based ISI Scores-3.07 ± 2.971-2.38 ± 2.984-1.45 ± 2.847-2.49 ± 2.769-1.91 ± 3.166-1.34 ± 3.285
SecondaryChange From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · Score on a Scale
Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score
Score on a ScaleMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score-4.6 ± 5.55-3.2 ± 5.32-2.6 ± 5.45-5.6 ± 7.04-3.3 ± 5.97-2.3 ± 6.34
SecondaryChange From Baseline to Week 8 in the DLQI Total Score

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.

Time frame:
Baseline, Week 8
Reported as:
Mean · Score on a Scale
Change From Baseline to Week 8 in the DLQI Total Score
Score on a ScaleMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
Change From Baseline to Week 8 in the DLQI Total Score-4.6 ± 5.16-2.6 ± 4.98-2.8 ± 4.01-5.0 ± 5.85-2.7 ± 4.79-2.2 ± 5.63
SecondaryPercentage 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

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).

Time frame:
Baseline, Week 12
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
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 Baseline8.817.57.313.214.57.7
SecondaryPercentage 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

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).

Time frame:
Baseline, Week 8
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QD
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 Baseline5.06.310.910.06.01.7

Adverse events

Collected over SAEs were assessed from informed consent through and including 28 calendar days after last administration of study treatment. Non-SAEs were recorded from time of first dose of study treatment through last participant visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mild/Moderate: Tofacitinib 20 mg/g BID—0/71 (0%)30/71 (42.3%)
Mild/Moderate: Tofacitinib 10 mg/g BID—5/70 (7.1%)29/70 (41.4%)
Mild/Moderate: Placebo (Vehicle) BID—2/71 (2.8%)27/71 (38%)
Mild/Moderate: Tofacitinib 20 mg/g QD—0/70 (0%)34/70 (48.6%)
Mild/Moderate: Tofacitinib 10 mg/g QD—2/74 (2.7%)28/74 (37.8%)
Mild/Moderate: Placebo (Vehicle) QD—1/74 (1.4%)40/74 (54.1%)
Severe: Tofacitinib 20 mg/g BID—0/7 (0%)2/7 (28.6%)
Severe: Tofacitinib 10 mg/g BID—0/7 (0%)4/7 (57.1%)
Severe: Placebo (Vehicle) BID—0/7 (0%)4/7 (57.1%)
Severe: Tofacitinib 20 mg/g QD—0/7 (0%)3/7 (42.9%)
Severe: Tofacitinib 10 mg/g QD—0/6 (0%)2/6 (33.3%)
Severe: Placebo (Vehicle) QD—1/7 (14.3%)2/7 (28.6%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QDSevere: Tofacitinib 20 mg/g BIDSevere: Tofacitinib 10 mg/g BIDSevere: Placebo (Vehicle) BIDSevere: Tofacitinib 20 mg/g QDSevere: Tofacitinib 10 mg/g QDSevere: Placebo (Vehicle) QD
Transient ischaemic attackNervous system disorders0/710/700/710/700/740/740/70/70/70/70/61/7
Cardiac failure congestiveCardiac disorders0/711/700/710/700/740/740/70/70/70/70/60/7
Myocardial infarctionCardiac disorders0/711/700/710/700/740/740/70/70/70/70/60/7
Non-cardiac chest painGeneral disorders0/711/700/710/700/740/740/70/70/70/70/60/7
Abdominal wound dehiscenceInjury, poisoning and procedural complications0/711/700/710/700/740/740/70/70/70/70/60/7
Diabetes mellitusMetabolism and nutrition disorders0/711/700/710/700/740/740/70/70/70/70/60/7
OsteoarthritisMusculoskeletal and connective tissue disorders0/710/701/710/700/740/740/70/70/70/70/60/7
Psoriatic arthropathyMusculoskeletal and connective tissue disorders0/710/701/710/700/740/740/70/70/70/70/60/7
ArrhythmiaCardiac disorders0/710/700/710/701/740/740/70/70/70/70/60/7
Atrial fibrillationCardiac disorders0/710/700/710/700/741/740/70/70/70/70/60/7
Most frequent other events
Showing 10 of 159
Most frequent other events
EventMild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QDSevere: Tofacitinib 20 mg/g BIDSevere: Tofacitinib 10 mg/g BIDSevere: Placebo (Vehicle) BIDSevere: Tofacitinib 20 mg/g QDSevere: Tofacitinib 10 mg/g QDSevere: Placebo (Vehicle) QD
PsoriasisSkin and subcutaneous tissue disorders1/711/700/717/706/746/741/70/70/72/70/61/7
Ear infectionInfections and infestations1/710/700/710/700/740/740/70/70/70/71/60/7
Nasal congestionRespiratory, thoracic and mediastinal disorders0/710/700/711/700/741/740/70/70/70/71/60/7
NasopharyngitisInfections and infestations3/712/701/715/707/7411/740/71/70/70/70/60/7
NauseaGastrointestinal disorders2/711/701/711/703/740/741/70/70/70/70/60/7
Chest painGeneral disorders0/710/701/710/700/740/740/70/71/70/70/60/7
FatigueGeneral disorders0/710/701/710/700/740/740/70/71/70/70/60/7
Oedema peripheralGeneral disorders0/710/700/711/700/740/740/71/70/70/70/60/7
BronchitisInfections and infestations2/711/700/711/701/741/741/70/71/70/70/60/7
Upper respiratory tract infectionInfections and infestations2/7110/706/712/700/741/741/70/70/70/70/60/7

Baseline characteristics

Full Analysis Set (FAS) - included all participants who were randomized to the study, received at least one dose of the randomized investigational drug (tofacitinib or vehicle), and were in a baseline PGA-C category of mild (2), moderate (3) or severe (4).

Age, Customized
Age, Customized(Participants)Mild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QDSevere: Tofacitinib 20 mg/g BIDSevere: Tofacitinib 10 mg/g BIDSevere: Placebo (Vehicle) BIDSevere: Tofacitinib 20 mg/g QDSevere: Tofacitinib 10 mg/g QDSevere: Placebo (Vehicle) QDTotal
< 18 years0000000000000
18-44 years302325213025201332165
45-64 years283434383539464222228
>= 65 years1313121191011221378
Sex: Female, Male
Sex: Female, Male(Participants)Mild/Moderate: Tofacitinib 20 mg/g BIDMild/Moderate: Tofacitinib 10 mg/g BIDMild/Moderate: Placebo (Vehicle) BIDMild/Moderate: Tofacitinib 20 mg/g QDMild/Moderate: Tofacitinib 10 mg/g QDMild/Moderate: Placebo (Vehicle) QDSevere: Tofacitinib 20 mg/g BIDSevere: Tofacitinib 10 mg/g BIDSevere: Placebo (Vehicle) BIDSevere: Tofacitinib 20 mg/g QDSevere: Tofacitinib 10 mg/g QDSevere: Placebo (Vehicle) QDTotal
Female282330332432131100176
Male434741375042646667295
08

Study locations

54 sites
  • Burke Pharmaceutical Research
    Hot Springs, Arkansas 71913, United States
  • Bakersfield Dermatology and Skin Cancer Medical Center
    Bakersfield, California 93304, United States
  • UC Irvine Dermatology Research
    Irvine, California 92697, United States
  • Dermatology Research Associates
    Los Angeles, California 90045, United States
  • Park Avenue Dermatology, PA
    Orange Park, Florida 32073, United States
  • Olympian Clinical Research
    Tampa, Florida 33609, United States
  • Atlanta Dermatology, Vein & Research Center
    Alpharetta, Georgia 30022, United States
  • Advanced Medical Research, Inc
    Atlanta, Georgia 30342, United States
  • MedaPhase Inc.
    Newnan, Georgia 30263, United States
  • Dundee Dermatology
    West Dundee, Illinois 60118, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
    Boston, Massachusetts 02114, United States
  • Michigan Center for Skin Care Research
    Clinton Township, Michigan 48038, United States
  • Dermatology Consulting Services
    High Point, North Carolina 27262, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27104, United States
  • Radiant Research, Inc.
    Cincinnati, Ohio 45249, United States
  • Oregon Dermatology and Research Center
    Portland, Oregon 97210, United States
  • Oregon Medical Research Center, PC
    Portland, Oregon 97223, United States
  • Clinical Partners, LLC
    Johnston, Rhode Island 02919, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Radiant Research, Inc.
    Greer, South Carolina 29650, United States
  • Health Concepts
    Rapid City, South Dakota 57702, United States
  • Dermatology Research Associates
    Nashville, Tennessee 37203, United States
  • Arlington Research Center Inc.
    Arlington, Texas 76011, United States
  • Dermatology Treatment and Research Center
    Dallas, Texas 75230, United States
  • Menter Dermatology Research Institute
    Dallas, Texas 75246, United States
  • Suzanne Bruce and Associates, PA
    Houston, Texas 77056, United States
  • Lee Medical Associates
    San Antonio, Texas 78229, United States
  • Progressive Clinical Research
    San Antonio, Texas 78229, United States
  • Stratica Medical
    Edmonton, Alberta T5K 1X3, Canada
  • Dermadvances Research
    Winnipeg, Manitoba R3C 1R4, Canada
  • CCA Medical Research Corporation
    Ajax, Ontario L1S 7K8, Canada
  • Ultranova Skincare
    Barrie, Ontario L4M 6L2, Canada
  • Dermatrials Research
    Hamilton, Ontario L8N 1V6, Canada
  • The Guenther Dermatology Research Centre
    London, Ontario N6A 3H7, Canada
  • Lynderm Research Inc
    Markham, Ontario L3P1X2, Canada
  • SKiN Centre for Dermatology
    Peterborough, Ontario K9J 1Z2, Canada
  • K. Papp Clinical Research Inc.
    Waterloo, Ontario N2J 1C4, Canada
  • XLR8 Medical Research
    Windsor, Ontario N8W 1E6, Canada
  • Innovaderm Research Inc
    Montreal, Quebec H2K 4L5, Canada
  • Siena Medical Research
    Montreal, Quebec H3Z 2S6, Canada
  • Dermatologisk Afdeling S
    Aarhus C, 8000, Denmark
  • Hudklinikken Herning
    Herning, 7400, Denmark
  • Klinika Ambroziak ESTEDERM Sp. z o.o.SKA
    Warszawa, Mazowieckie 02-758, Poland
  • NZOZ Solumed
    Poznan, Wielkopolskie 60-539, Poland
  • Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
    Bialystok, 15-351, Poland
  • NZOZ Centrum Osteoporozy i Chorob Kostno-Stawowych J. Badurski Spolka Jawna
    Bialystok, 15-879, Poland
  • Pomorskie Centrum Traumatologii im.Mikolaja Kopernika w Gdansku Oddzial Dermatologii
    Gdansk, 80-152, Poland
  • Krakowskie Centrum Medyczne Sp. z o.o.
    Krakow, 31-501, Poland
  • Maxxmed Centrum Zdrowia i Urody
    Lublin, 20-080, Poland
  • Gabinet Lekarski RTG USG Dr n. med. Pawel Skrzywanek; Pracownia Radiologiczna
    Poznan, 61-841, Poland
  • Wojskowy Instytut Medyczny
    Warszawa 44, 04-141, Poland
  • High-Med. Przychodnia Specjalistyczna
    Warszawa, 01-817, Poland
  • NZOZ multiMedica
    Wroclaw, 51-318, Poland
09

References and documents

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. doi: 10.1186/s12895-016-0051-4. PubMed 27716172 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01831466
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Apr 15, 2013
Start date
May 2013
Primary completion
Sep 2014
Completion
Sep 2014
Results posted
Nov 25, 2015
Last update
Nov 25, 2015

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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