Psoriasis VulgarisPhase 2NCT01831466
Tofacitinib Ointment For Chronic Plaque Psoriasis
A Phase 2 study testing tofacitinib ointment 20 mg/g and tofacitinib ointment 10 mg/g in people with Psoriasis Vulgaris and Psoriasis, run by Pfizer at 54 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris, Psoriasis
- What is being tested?
- tofacitinib ointment 20 mg/g and tofacitinib ointment 10 mg/g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 54 sitesin 4 countries
- Study dates
- May 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
54 sites in 4 countries.
54 sites in 4 countries
United States29 sites
Atlanta Dermatology, Vein & Research Center
Alpharetta, Georgia, 30022
Arlington Research Center Inc.
Arlington, Texas, 76011
Advanced Medical Research, Inc
Atlanta, Georgia, 30342
Bakersfield Dermatology and Skin Cancer Medical Center
Bakersfield, California, 93304
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, 02114
Radiant Research, Inc.
Cincinnati, Ohio, 45249
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Menter Dermatology Research Institute
Dallas, Texas, 75246
Radiant Research, Inc.
Greer, South Carolina, 29650
Dermatology Consulting Services
High Point, North Carolina, 27262
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
UC Irvine Dermatology Research
Irvine, California, 92697
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Dermatology Research Associates
Los Angeles, California, 90045
Dermatology Research Associates
Nashville, Tennessee, 37203
MedaPhase Inc.
Newnan, Georgia, 30263
Park Avenue Dermatology, PA
Orange Park, Florida, 32073
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Rhode Island Hospital
Providence, Rhode Island, 02903
Health Concepts
Rapid City, South Dakota, 57702
Lee Medical Associates
San Antonio, Texas, 78229
Progressive Clinical Research
San Antonio, Texas, 78229
Olympian Clinical Research
Tampa, Florida, 33609
Dundee Dermatology
West Dundee, Illinois, 60118
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104
Canada12 sites
CCA Medical Research Corporation
Ajax, Ontario, L1S 7K8
Ultranova Skincare
Barrie, Ontario, L4M 6L2
Stratica Medical
Edmonton, Alberta, T5K 1X3
Dermatrials Research
Hamilton, Ontario, L8N 1V6
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
Lynderm Research Inc
Markham, Ontario, L3P1X2
Innovaderm Research Inc
Montreal, Quebec, H2K 4L5
Siena Medical Research
Montreal, Quebec, H3Z 2S6
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 1Z2
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
XLR8 Medical Research
Windsor, Ontario, N8W 1E6
Dermadvances Research
Winnipeg, Manitoba, R3C 1R4
Poland11 sites
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, 15-351
NZOZ Centrum Osteoporozy i Chorob Kostno-Stawowych J. Badurski Spolka Jawna
Bialystok, 15-879
Pomorskie Centrum Traumatologii im.Mikolaja Kopernika w Gdansku Oddzial Dermatologii
Gdansk, 80-152
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501
Maxxmed Centrum Zdrowia i Urody
Lublin, 20-080
NZOZ Solumed
Poznan, Greater Poland Voivodeship, 60-539
Gabinet Lekarski RTG USG Dr n. med. Pawel Skrzywanek; Pracownia Radiologiczna
Poznan, 61-841
Klinika Ambroziak ESTEDERM Sp. z o.o.SKA
Warsaw, Masovian Voivodeship, 02-758
High-Med. Przychodnia Specjalistyczna
Warsaw, 01-817
Wojskowy Instytut Medyczny
Warsaw, 04-141
NZOZ multiMedica
Wroclaw, 51-318
Denmark2 sites
Dermatologisk Afdeling S
Aarhus C, 8000
Hudklinikken Herning
Herning, 7400
About this study
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.
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.
- Conditions
- Psoriasis Vulgaris, Psoriasis
- Being tested
- tofacitinib ointment 20 mg/g, tofacitinib ointment 10 mg/g, placebo ointment (vehicle)
- Keywords
- plaque psoriasis, vulgaris, topical treatment, skin diseases, papulosquamous, Tofacitinib, CP-690550, Xeljanz, psoriasis, moderate, severe, itch, nail psoriasis
- Medical subject headings
- Psoriasis, Skin Diseases, Lymphoma, Follicular, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tofacitinib ointment 20 mg/gDrug
tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
tofacitinib ointment 10 mg/gDrug
tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
placebo ointment (vehicle)Drug
placebo ointment (vehicle) BID (twice daily) for 12 weeks
tofacitinib ointment 20 mg/gDrug
tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
tofacitinib ointment 10 mg/gDrug
tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
placebo ointment (vehicle)Drug
placebo ointment (vehicle) QD (once daily) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | Not described Receives: Drug: tofacitinib ointment 20 mg/g |
| Treatment Group B | Experimental | Not described Receives: Drug: tofacitinib ointment 10 mg/g |
| Treatment Group C | Placebo comparator | Not described Receives: Drug: placebo ointment (vehicle) |
| Treatment Group D | Experimental | Not described Receives: Drug: tofacitinib ointment 20 mg/g |
| Treatment Group E | Experimental | Not described Receives: Drug: tofacitinib ointment 10 mg/g |
| Treatment Group F | Placebo comparator | Not described Receives: Drug: placebo ointment (vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 8
Secondary outcomes (16)
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.
Measured: Week 12
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.
Measured: Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 8
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).
Measured: Baseline, Week 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).
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 8
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831466
- Sponsor's protocol ID
- A3921082
- Other IDs
- 2012-005645-20
- Status last verified
- Oct 2015
- First submitted
- 28 Mar 2013
- Last updated
- 25 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01831466
- Acronym / sponsor ID
- A3921082
- Conditions
- Psoriasis Vulgaris, Psoriasis
- Keywords
- plaque psoriasis, vulgaris, topical treatment, skin diseases, papulosquamous, Tofacitinib, CP-690550, Xeljanz
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Posted 25 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: tofacitinib ointment 20 mg/g |
| Treatment Group B | Experimental | Drug: tofacitinib ointment 10 mg/g |
| Treatment Group C | Placebo comparator | Drug: placebo ointment (vehicle) |
| Treatment Group D | Experimental | Drug: tofacitinib ointment 20 mg/g |
| Treatment Group E | Experimental | Drug: tofacitinib ointment 10 mg/g |
| Treatment Group F | Placebo comparator | Drug: placebo ointment (vehicle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tofacitinib ointment 20 mg/gtofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks | Drug | Treatment Group A |
| tofacitinib ointment 10 mg/gtofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks | Drug | Treatment Group B |
| placebo ointment (vehicle)placebo ointment (vehicle) BID (twice daily) for 12 weeks | Drug | Treatment Group C |
| tofacitinib ointment 20 mg/gtofacitinib ointment 20 mg/g QD (once daily) for 12 weeks | Drug | Treatment Group D |
| tofacitinib ointment 10 mg/gtofacitinib ointment 10 mg/g QD (once daily) for 12 weeks | Drug | Treatment Group E |
| placebo ointment (vehicle)placebo ointment (vehicle) QD (once daily) for 12 weeks | Drug | Treatment Group F |
Primary outcome
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.
16 secondary outcomes
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12
Time frame: Week 12
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8
Time frame: Week 8
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
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
Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline, Week 12
Percent Change From Baseline to Week 8 in PASI
Time frame: Baseline, Week 8
Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8
Time frame: Baseline, Week 8
Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis
Time frame: Baseline, Week 12
Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores
Time frame: Baseline, Week 12
Change From Baseline to Week 8 in Clinic-Based ISI Scores
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score
Time frame: Baseline, Week 12
Change From Baseline to Week 8 in the DLQI Total Score
Time frame: Baseline, Week 8
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27716172Papp 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
54 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tofacitinib ointment 20 mg/g and tofacitinib ointment 10 mg/g in people with Psoriasis Vulgaris and Psoriasis, run by Pfizer at 54 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada, Poland, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01831466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.