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Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

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ClinicalTrials.gov Identifier: NCT02001181
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : October 15, 2015
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Interventions Drug: Tofacitinib ointment 20mg/g
Drug: Placebo ointment (Vehicle)
Enrollment 69
Recruitment Details Eligibility included male or female participants, 18 to 60 years of age (inclusive), who had a clinical diagnosis of atopic dermatitis for at least 6 months and clinically stable for >=1 month.
Pre-assignment Details During the screening/washout period, participants' current therapies (topical, systemic, and phototherapy) for atopic dermatitis were discontinued and only non-medicated study emollient, sunscreen topical products, and specific shampoos (for atopic dermatitis on hair-bearing scalp) were permitted.
Arm/Group Title Tofacitinib 20 mg/g BID Vehicle BID
Hide Arm/Group Description Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Period Title: Overall Study
Started 35 34
Completed 34 31
Not Completed 1 3
Reason Not Completed
Adverse Event             0             2
Lost to Follow-up             1             0
Withdrawal by Subject             0             1
Arm/Group Title Tofacitinib 20 mg/g BID Vehicle BID Total
Hide Arm/Group Description Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 35 34 69
Hide Baseline Analysis Population Description
The full analysis set included all participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 34 participants 69 participants
32.4  (9.8) 30.4  (10.4) 31.4  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
Female
19
  54.3%
18
  52.9%
37
  53.6%
Male
16
  45.7%
16
  47.1%
32
  46.4%
1.Primary Outcome
Title Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
Hide Description The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.
Time Frame Baseline (pre-dose on Day 1) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.
Arm/Group Title Tofacitinib 20 mg/g BID Vehicle BID
Hide Arm/Group Description:
Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Overall Number of Participants Analyzed 34 31
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-81.7  (6.31) -29.9  (6.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 20 mg/g BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The mixed model for repeated measures analysis included all the participants in FAS.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -51.8
Confidence Interval (2-Sided) 80%
-62.8 to -40.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.48
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4
Hide Description The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.
Arm/Group Title Tofacitinib 20 mg/g BID Vehicle BID
Hide Arm/Group Description:
Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Overall Number of Participants Analyzed 35 34
Measure Type: Number
Unit of Measure: percentage of participants
71.4 20.6
3.Secondary Outcome
Title Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4
Hide Description The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.
Time Frame Baseline (pre-dose on Day 1) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.
Arm/Group Title Tofacitinib 20 mg/g BID Vehicle BID
Hide Arm/Group Description:
Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Overall Number of Participants Analyzed 35 34
Measure Type: Number
Unit of Measure: percentage of participants
65.7 11.8
4.Secondary Outcome
Title Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4
Hide Description The percent BSA with atopic dermatitis in a body region was determined by the number of handprints of atopic dermatitis skin in that region: head and neck, upper limbs, trunk including axillae, lower limbs including buttocks. In the handprint method, the full palmar hand of the participant (i.e., the participant's fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. What is reported is the percent change from baseline in BSA affected.
Time Frame Baseline (pre-dose on Day 1) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.
Arm/Group Title Tofacitinib 20 mg/g BID Vehicle BID
Hide Arm/Group Description:
Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Overall Number of Participants Analyzed 34 31
Mean (Standard Deviation)
Unit of Measure: percent change
-72.7  (34.1) -30.2  (39.4)
5.Secondary Outcome
Title Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4
Hide Description The EASI Clinical Signs Severity Sum Score was derived from the EASI. The Clinical Signs Severity Scores on the 4-point scale for dermatitis lesions were summed in each EASI body region. The sum of the Clinical Signs Severity Score in each EASI body region was then totaled across the 4 EASI body regions to provide an EASI Clinical Signs Severity Sum Score, which ranged from 0 to 48, with higher scores representing greater severity of atopic dermatitis.
Time Frame Baseline (pre-dose on Day 1) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.
Arm/Group Title Tofacitinib 20 mg/g BID Vehicle BID
Hide Arm/Group Description:
Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Overall Number of Participants Analyzed 34 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.4  (5.3) -4.1  (4.5)
Time Frame Baseline up to 28 days after last study drug administration
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Tofacitinib 20 mg/g BID Vehicle BID
Hide Arm/Group Description Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
All-Cause Mortality
Tofacitinib 20 mg/g BID Vehicle BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tofacitinib 20 mg/g BID Vehicle BID
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/34 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tofacitinib 20 mg/g BID Vehicle BID
Affected / at Risk (%) Affected / at Risk (%)
Total   11/35 (31.43%)   19/34 (55.88%) 
Eye disorders     
Conjunctivitis allergic * 1  0/35 (0.00%)  1/34 (2.94%) 
Gastrointestinal disorders     
Nausea * 1  1/35 (2.86%)  0/34 (0.00%) 
General disorders     
Application site pain * 1  1/35 (2.86%)  0/34 (0.00%) 
Application site pruritus * 1  1/35 (2.86%)  1/34 (2.94%) 
Immune system disorders     
Seasonal allergy * 1  0/35 (0.00%)  1/34 (2.94%) 
Infections and infestations     
Bronchitis * 1  1/35 (2.86%)  0/34 (0.00%) 
Furuncle * 1  1/35 (2.86%)  0/34 (0.00%) 
Gastroenteritis * 1  1/35 (2.86%)  0/34 (0.00%) 
Nasopharyngitis * 1  2/35 (5.71%)  2/34 (5.88%) 
Upper respiratory tract infection * 1  0/35 (0.00%)  1/34 (2.94%) 
Viral upper respiratory tract infection * 1  1/35 (2.86%)  0/34 (0.00%) 
Injury, poisoning and procedural complications     
Arthropod bite * 1  0/35 (0.00%)  1/34 (2.94%) 
Sunburn * 1  0/35 (0.00%)  1/34 (2.94%) 
Investigations     
Aspartate aminotransferase increased * 1  0/35 (0.00%)  1/34 (2.94%) 
Blood bilirubin increased * 1  0/35 (0.00%)  1/34 (2.94%) 
Blood creatine phosphokinase increased * 1  0/35 (0.00%)  3/34 (8.82%) 
Neutrophil count decreased * 1  0/35 (0.00%)  1/34 (2.94%) 
White blood cell count decreased * 1  0/35 (0.00%)  1/34 (2.94%) 
Nervous system disorders     
Headache * 1  1/35 (2.86%)  2/34 (5.88%) 
Psychiatric disorders     
Initial insomnia * 1  1/35 (2.86%)  0/34 (0.00%) 
Panic attack * 1  0/35 (0.00%)  1/34 (2.94%) 
Renal and urinary disorders     
Dysuria * 1  0/35 (0.00%)  1/34 (2.94%) 
Skin and subcutaneous tissue disorders     
Dermal cyst * 1  0/35 (0.00%)  1/34 (2.94%) 
Dermatitis contact * 1  0/35 (0.00%)  3/34 (8.82%) 
Night sweats * 1  0/35 (0.00%)  1/34 (2.94%) 
Skin irritation * 1  0/35 (0.00%)  1/34 (2.94%) 
Urticaria * 1  1/35 (2.86%)  1/34 (2.94%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02001181    
Other Study ID Numbers: A3921214
First Submitted: November 27, 2013
First Posted: December 4, 2013
Results First Submitted: September 16, 2015
Results First Posted: October 15, 2015
Last Update Posted: October 15, 2015