Tofacitinib Ointment For Chronic Plaque Psoriasis | NCT01831466 | Trialant
NCT01831466
Sponsor
Pfizer
Status
Completed
Last Update Posted
Nov 25, 2015Estimated
Enrollment
476Actual
Phase
Phase 2
Conditions
Psoriasis Vulgaris
Psoriasis
Interventions
tofacitinib ointment 20 mg/g
tofacitinib ointment 10 mg/g
placebo ointment (vehicle)
tofacitinib ointment 20 mg/g
tofacitinib ointment 10 mg/g
placebo ointment (vehicle)
Countries
United States
Canada
Denmark
Poland
Protocol Section
Identification Module
NCT ID
NCT01831466
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A3921082
Secondary IDs
ID
Type
Description
Link
2012-005645-20
EudraCT Number
Brief Title
Tofacitinib Ointment For Chronic Plaque Psoriasis
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.
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Oct 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2013
Primary Completion Date
Sep 2014Actual
Completion Date
Sep 2014Actual
First Submitted Date
Mar 28, 2013
First Submission Date that Met QC Criteria
Apr 10, 2013
First Posted Date
Apr 15, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 15, 2015
Results First Submitted that Met QC Criteria
Oct 26, 2015
Results First Posted Date
Nov 25, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 26, 2015
Last Update Posted Date
Nov 25, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis Vulgaris
Psoriasis
Keywords
plaque psoriasis
vulgaris
topical treatment
skin diseases
papulosquamous
Tofacitinib
CP-690550
Xeljanz
psoriasis
moderate
severe
itch
nail psoriasis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
476Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
tofacitinib ointment 20 mg/g
Drug
tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
Treatment Group A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
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.
Baseline, Week 8
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline
At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails)
If received certain treatments, should be off treatment for a minimum period of time (washout)
Exclusion Criteria:
Currently have non-plaque forms of psoriasis or drug-induced psoriasis
Require treatment with or cannot stop medication(s) prohibited during the study
Have certain laboratory abnormalities at Baseline
Current or history of certain infections
Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Burke Pharmaceutical Research
Hot Springs
Arkansas
71913
United States
Bakersfield Dermatology and Skin Cancer Medical Center
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.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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.
Participants with a baseline Calculated Physician's Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
Treatment Group B
placebo ointment (vehicle)
Drug
placebo ointment (vehicle) BID (twice daily) for 12 weeks
Treatment Group C
tofacitinib ointment 20 mg/g
Drug
tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
Treatment Group D
tofacitinib ointment 10 mg/g
Drug
tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
Treatment Group E
placebo ointment (vehicle)
Drug
placebo ointment (vehicle) QD (once daily) for 12 weeks
Treatment Group F
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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).
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).
Baseline, Week 8
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
NZOZ Solumed
Poznan
Greater Poland Voivodeship
60-539
Poland
Klinika Ambroziak ESTEDERM Sp. z o.o.SKA
Warsaw
Masovian Voivodeship
02-758
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
High-Med. Przychodnia Specjalistyczna
Warsaw
01-817
Poland
Wojskowy Instytut Medyczny
Warsaw
04-141
Poland
NZOZ multiMedica
Wroclaw
51-318
Poland
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
FG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
FG003
Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
FG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
FG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
FG006
Severe: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
FG007
Severe: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
FG008
Severe: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
FG009
Severe: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
FG010
Severe: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
FG011
Severe: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
FG00071 subjectsTreated
FG00170 subjectsTreated
FG00271 subjectsTreated
FG00370 subjectsTreated
FG00474 subjectsTreated
FG00574 subjectsTreated
FG0067 subjectsTreated
FG0077 subjectsTreated
FG0087 subjectsTreated
FG0097 subjectsTreated
FG0106 subjectsTreated
FG0117 subjectsTreated
COMPLETED
FG00055 subjects
FG00152 subjects
FG00248 subjects
FG00351 subjects
FG00457 subjects
FG00548 subjects
FG0066 subjects
FG0075 subjects
FG0084 subjects
FG0092 subjects
FG0104 subjects
FG0113 subjects
NOT COMPLETED
FG00016 subjects
FG00118 subjects
FG00223 subjects
FG00319 subjects
FG00417 subjects
FG00526 subjects
FG0061 subjects
FG0072 subjects
FG0083 subjects
FG0095 subjects
FG0102 subjects
FG0114 subjects
Type
Comment
Reasons
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Other
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG004
Non-compliance with study treatment
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG004
Lack of Efficacy
FG0005 subjects
FG0018 subjects
FG0027 subjects
FG0036 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0036 subjects
FG004
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).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
BG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
BG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
BG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
BG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
BG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
BG006
Severe: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
BG007
Severe: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
BG008
Severe: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
BG009
Severe: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
BG010
Severe: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
BG011
Severe: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00071
BG00170
BG00271
BG00370
BG00474
BG00574
BG0067
BG0077
BG0087
BG0097
BG0106
BG0117
BG012471
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
< 18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00028
BG00123
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
The mild/moderate full analysis set (FASm) included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00071
OG00170
OG00271
OG003
Title
Denominators
Categories
Title
Measurements
OG00021.1
OG00112.9
OG00216.9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
0.5425
Difference in response rates
3.9
Standard Error of the Mean
6.36
2-Sided
80
-4.3
12.0
No
Superiority or Other
OG001
OG002
Cochran-Mantel-Haenszel
Primary
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.
FASm. A participant with a missing value was considered a non-responder.
Posted
Number
Percentage of Participants
Baseline, Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Secondary
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.
FASm. A participant with a missing value was considered a non-responder.
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Secondary
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.
FASm. A participant with a missing value was considered a non-responder.
Posted
Number
Percentage of Participants
Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Secondary
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.
FASm. A participant with a missing value was considered a non-responder.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Secondary
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.
FASm. A participant with a missing value was considered a non-responder.
Posted
Number
Percentage of Participants
Baseline, Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Secondary
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.
FASm. Only observed data were analyzed.
Posted
Mean
Standard Deviation
Percent Change from Baseline
Baseline, Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Secondary
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.
FASm. Only observed data were analyzed.
Posted
Mean
Standard Deviation
Percent Change from Baseline
Baseline, Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Secondary
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.
FASm. A participant with a missing value was considered a non-responder.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Secondary
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.
FASm. A participant with a missing value was considered a non-responder.
Posted
Number
Percentage of Participants
Baseline, Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Secondary
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.
FASm. Only observed data were analyzed.
Posted
Mean
Standard Deviation
Percent Change from Baseline
Baseline, Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Secondary
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.
FASm. Only observed data were analyzed.
Posted
Mean
Standard Deviation
Percent Change from Baseline
Baseline, Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Secondary
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).
FASm. Only observed data were analyzed.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Secondary
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).
FASm. Only observed data were analyzed.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline, Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Secondary
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.
FASm. Only observed data were analyzed.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Secondary
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.
FASm. Only observed data were analyzed.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline, Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Secondary
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).
FASm. Only observed data were analyzed.
Posted
Number
Percentage of Participants
Baseline, Week 12
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Secondary
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).
FASm. Only observed data were analyzed.
Posted
Number
Percentage of Participants
Baseline, Week 8
ID
Title
Description
OG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
OG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Time Frame
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.
Description
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. All AEs (including treatment area AEs) are presented.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Mild/Moderate: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
0
71
30
71
EG001
Mild/Moderate: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
5
70
29
70
EG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
2
71
27
71
EG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
0
70
34
70
EG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
2
74
28
74
EG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
1
74
40
74
EG006
Severe: Tofacitinib 20 mg/g BID
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
0
7
2
7
EG007
Severe: Tofacitinib 10 mg/g BID
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
0
7
4
7
EG008
Severe: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
0
7
4
7
EG009
Severe: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
0
7
3
7
EG010
Severe: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
0
6
2
6
EG011
Severe: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
1
7
2
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arrhythmia
Cardiac disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG0030 affected70 at risk
EG0041 affected74 at risk
EG0050 affected74 at risk
EG0060 affected7 at risk
EG0070 affected7 at risk
EG0080 affected7 at risk
EG0090 affected7 at risk
EG0100 affected6 at risk
EG0110 affected7 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Abdominal wound dehiscence
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG0030 affected70 at risk
EG0041 affected74 at risk
EG0050 affected74 at risk
EG0060 affected7 at risk
EG0070 affected7 at risk
EG0080 affected7 at risk
EG0090 affected7 at risk
EG0100 affected6 at risk
EG0110 affected7 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0012 affected70 at risk
EG0020 affected71 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0002 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0002 affected71 at risk
EG0011 affected70 at risk
EG0021 affected71 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Application site pain
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Application site papules
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Asthenia
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Chest pain
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Fatigue
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Influenza like illness
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Pyrexia
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0002 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Chronic tonsillitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Ear infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Infected bites
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0003 affected71 at risk
EG0012 affected70 at risk
EG0021 affected71 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Paronychia
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Sepsis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0011 affected70 at risk
EG0022 affected71 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0002 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0002 affected71 at risk
EG00110 affected70 at risk
EG0026 affected71 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0012 affected70 at risk
EG0026 affected71 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Accident at work
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Burns first degree
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Drug dispensing error
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0021 affected71 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0012 affected70 at risk
EG0020 affected71 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0012 affected70 at risk
EG0020 affected71 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Eosinophil percentage increased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Vitamin B12 decreased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0012 affected70 at risk
EG0022 affected71 at risk
EG003
Migraine
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Stress
Psychiatric disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0011 affected70 at risk
EG0022 affected71 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Nail psoriasis
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0002 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Haematoma
Vascular disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0011 affected70 at risk
EG0020 affected71 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0021 affected71 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Application site pruritus
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Cystitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Cystitis escherichia
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Impetigo
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0010 affected70 at risk
EG0020 affected71 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected71 at risk
EG0011 affected70 at risk
EG0021 affected71 at risk
EG003
Efficacy results for participants in the severe population were not reported since this was considered an exploratory population.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI must remove any previously undisclosed Confidential Information (other than the Study results themselves) before public release.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D011565
Psoriasis
D012871
Skin Diseases
D008224
Lymphoma, Follicular
D011537
Pruritus
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D017437
Skin and Connective Tissue Diseases
D008228
Lymphoma, Non-Hodgkin
D008223
Lymphoma
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D006425
Hemic and Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D012877
Skin Manifestations
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
3 subjects
FG0055 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
0 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
9 subjects
FG0058 subjects
FG0061 subjects
FG0071 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
FG0110 subjects
3 subjects
FG0057 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0112 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
18-44 years
Title
Measurements
BG00030
BG00123
BG00225
BG00321
BG00430
BG00525
BG0062
BG0070
BG0081
BG0093
BG0103
BG0112
BG012165
45-64 years
Title
Measurements
BG00028
BG00134
BG00234
BG00338
BG00435
BG00539
BG0064
BG0076
BG0084
BG0092
BG0102
BG0112
BG012228
>= 65 years
Title
Measurements
BG00013
BG00113
BG00212
BG00311
BG0049
BG00510
BG0061
BG0071
BG0082
BG0092
BG0101
BG0113
BG01278
30
BG00333
BG00424
BG00532
BG0061
BG0073
BG0081
BG0091
BG0100
BG0110
BG012176
Male
BG00043
BG00147
BG00241
BG00337
BG00450
BG00542
BG0066
BG0074
BG0086
BG0096
BG0106
BG0117
BG012295
70
OG00474
OG00574
20.0
OG00421.6
OG00517.6
0.4976
Difference in response rates
-4.0
Standard Error of the Mean
5.87
2-Sided
80
-11.5
3.5
No
Superiority or Other
OG003
OG005
Cochran-Mantel-Haenszel
0.6039
Difference in response rates
3.3
Standard Error of the Mean
6.36
2-Sided
80
-4.9
11.5
No
Superiority or Other
OG004
OG005
Cochran-Mantel-Haenszel
0.5279
Difference in response rate
4.0
Standard Error of the Mean
6.34
2-Sided
80
-4.1
12.1
No
Superiority or Other
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00071
OG00170
OG00271
OG00370
OG00474
OG00574
Title
Denominators
Categories
Title
Measurements
OG00022.5
OG00110.0
OG00211.3
OG00318.6
OG00414.9
OG0058.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
0.0710
Difference in response rates
10.8
Standard Error of the Mean
5.99
2-Sided
80
3.1
18.5
No
Superiority or Other
OG001
OG002
Cochran-Mantel-Haenszel
0.8175
Difference in response rates
-1.2
Standard Error of the Mean
5.20
2-Sided
80
-7.9
5.5
No
Superiority or Other
OG003
OG005
Cochran-Mantel-Haenszel
0.0513
Difference in response rates
11.0
Standard Error of the Mean
5.63
2-Sided
80
3.8
18.2
No
Superiority or Other
OG004
OG005
Cochran-Mantel-Haenszel
0.2021
Difference in response rates
6.7
Standard Error of the Mean
5.23
2-Sided
80
-0.0
13.4
No
Superiority or Other
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00071
OG00170
OG00271
OG00370
OG00474
OG00574
Title
Denominators
Categories
Title
Measurements
OG00033.8
OG00125.7
OG00223.9
OG00327.1
OG00429.7
OG00523.0
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00071
OG00170
OG00271
OG00370
OG00474
OG00574
Title
Denominators
Categories
Title
Measurements
OG00036.6
OG00120.0
OG00222.5
OG00332.9
OG00421.6
OG00512.2
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00071
OG00170
OG00271
OG00370
OG00474
OG00574
Title
Denominators
Categories
Title
Measurements
OG00018.3
OG00111.4
OG00214.1
OG00315.7
OG00418.9
OG00512.2
OG002
Mild/Moderate: Placebo (Vehicle) BID
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00071
OG00170
OG00271
OG00370
OG00474
OG00574
Title
Denominators
Categories
Title
Measurements
OG00021.1
OG0017.1
OG00211.3
OG00315.7
OG0049.5
OG0054.1
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00058
OG00157
OG00255
OG00353
OG00462
OG00552
Title
Denominators
Categories
Title
Measurements
OG000-36.6± 40.88
OG001-35.7± 43.78
OG002-32.0± 49.47
OG003-38.6± 36.37
OG004-31.4± 42.36
OG005-30.0± 38.68
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00061
OG00164
OG00255
OG00360
OG00467
OG00558
Title
Denominators
Categories
Title
Measurements
OG000-36.7± 36.01
OG001-29.1± 40.86
OG002-28.8± 37.06
OG003-36.5± 33.87
OG004-29.0± 29.47
OG005-27.1± 32.93
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00071
OG00170
OG00271
OG00370
OG00474
OG00574
Title
Denominators
Categories
Title
Measurements
OG00016.9
OG00112.9
OG00212.7
OG00315.7
OG00410.8
OG0056.8
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00071
OG00170
OG00271
OG00370
OG00474
OG00574
Title
Denominators
Categories
Title
Measurements
OG00014.1
OG0018.6
OG0027.0
OG00315.7
OG0046.8
OG0056.8
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00058
OG00157
OG00255
OG00353
OG00462
OG00552
Title
Denominators
Categories
Title
Measurements
OG000-32.8± 40.92
OG001-27.5± 36.40
OG002-27.7± 43.43
OG003-24.6± 36.29
OG004-15.6± 36.63
OG005-11.2± 56.38
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00061
OG00164
OG00255
OG00360
OG00467
OG00558
Title
Denominators
Categories
Title
Measurements
OG000-25.4± 44.75
OG001-22.5± 35.87
OG002-20.5± 34.90
OG003-17.8± 28.59
OG004-9.0± 30.08
OG005-11.7± 38.29
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00057
OG00157
OG00255
OG00352
OG00462
OG00552
Title
Denominators
Categories
Title
Measurements
OG000-2.88± 3.140
OG001-2.89± 3.320
OG002-1.73± 2.460
OG003-2.38± 3.182
OG004-1.94± 3.151
OG005-1.50± 2.961
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00061
OG00164
OG00255
OG00359
OG00466
OG00558
Title
Denominators
Categories
Title
Measurements
OG000-3.07± 2.971
OG001-2.38± 2.984
OG002-1.45± 2.847
OG003-2.49± 2.769
OG004-1.91± 3.166
OG005-1.34± 3.285
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00058
OG00157
OG00255
OG00353
OG00462
OG00552
Title
Denominators
Categories
Title
Measurements
OG000-4.6± 5.55
OG001-3.2± 5.32
OG002-2.6± 5.45
OG003-5.6± 7.04
OG004-3.3± 5.97
OG005-2.3± 6.34
OG003
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00061
OG00164
OG00255
OG00360
OG00467
OG00558
Title
Denominators
Categories
Title
Measurements
OG000-4.6± 5.16
OG001-2.6± 4.98
OG002-2.8± 4.01
OG003-5.0± 5.85
OG004-2.7± 4.79
OG005-2.2± 5.63
Mild/Moderate: Tofacitinib 20 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Units
Counts
Participants
OG00057
OG00157
OG00255
OG00353
OG00462
OG00552
Title
Denominators
Categories
Title
Measurements
OG0008.8
OG00117.5
OG0027.3
OG00313.2
OG00414.5
OG0057.7
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
OG004
Mild/Moderate: Tofacitinib 10 mg/g QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
OG005
Mild/Moderate: Placebo (Vehicle) QD
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.