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
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 476 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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. |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |
Arm | Intervention/treatment |
---|---|
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 |
- 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.
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831466

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01831466 |
Other Study ID Numbers: |
A3921082 2012-005645-20 ( EudraCT Number ) |
First Posted: | April 15, 2013 Key Record Dates |
Results First Posted: | November 25, 2015 |
Last Update Posted: | November 25, 2015 |
Last Verified: | October 2015 |
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