Trial Outcomes & Findings for Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema) (NCT NCT02001181)

NCT ID: NCT02001181

Last Updated: 2015-10-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

Baseline (pre-dose on Day 1) and Week 4

Results posted on

2015-10-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Tofacitinib 20 mg/g BID Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Overall Study STARTED	35	34
Overall Study COMPLETED	34	31
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib 20 mg/g BID Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib 20 mg/g BID n=35 Participants Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID n=34 Participants Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.	Total n=69 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 9.8 • n=5 Participants	30.4 years STANDARD_DEVIATION 10.4 • n=7 Participants	31.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1) and Week 4

Population: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib 20 mg/g BID n=34 Participants Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID n=31 Participants Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4	-81.7 percent change Standard Error 6.31	-29.9 percent change Standard Error 6.46

SECONDARY outcome

Timeframe: Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 20 mg/g BID n=35 Participants Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID n=34 Participants Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4	71.4 percentage of participants	20.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1) and Week 4

Outcome measures

Outcome measures
Measure	Tofacitinib 20 mg/g BID n=35 Participants Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID n=34 Participants Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
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	65.7 percentage of participants	11.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1) and Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 20 mg/g BID n=34 Participants Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID n=31 Participants Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4	-72.7 percent change Standard Deviation 34.1	-30.2 percent change Standard Deviation 39.4

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1) and Week 4

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 20 mg/g BID n=34 Participants Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID n=31 Participants Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4	-11.4 units on a scale Standard Deviation 5.3	-4.1 units on a scale Standard Deviation 4.5

Adverse Events

Tofacitinib 20 mg/g BID

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Vehicle BID

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Tofacitinib 20 mg/g BID n=35 participants at risk Participants received tofacitinib (20 milligrams per gram \[mg/g, 2%\]) topical ointment to the treatment area twice a day (BID) for 4 weeks.	Vehicle BID n=34 participants at risk Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	8.8% 3/34 • Baseline up to 28 days after last study drug administration 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.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Skin and subcutaneous tissue disorders Urticaria	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Eye disorders Conjunctivitis allergic	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Gastrointestinal disorders Nausea	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	0.00% 0/34 • Baseline up to 28 days after last study drug administration 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.
General disorders Application site pain	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	0.00% 0/34 • Baseline up to 28 days after last study drug administration 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.
General disorders Application site pruritus	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Immune system disorders Seasonal allergy	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Infections and infestations Bronchitis	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	0.00% 0/34 • Baseline up to 28 days after last study drug administration 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.
Infections and infestations Furuncle	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	0.00% 0/34 • Baseline up to 28 days after last study drug administration 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.
Infections and infestations Gastroenteritis	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	0.00% 0/34 • Baseline up to 28 days after last study drug administration 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.
Infections and infestations Nasopharyngitis	5.7% 2/35 • Baseline up to 28 days after last study drug administration 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.	5.9% 2/34 • Baseline up to 28 days after last study drug administration 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.
Infections and infestations Upper respiratory tract infection	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Infections and infestations Viral upper respiratory tract infection	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	0.00% 0/34 • Baseline up to 28 days after last study drug administration 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.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Injury, poisoning and procedural complications Sunburn	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Investigations Aspartate aminotransferase increased	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Investigations Blood bilirubin increased	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Investigations Blood creatine phosphokinase increased	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	8.8% 3/34 • Baseline up to 28 days after last study drug administration 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.
Investigations Neutrophil count decreased	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Investigations White blood cell count decreased	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Nervous system disorders Headache	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	5.9% 2/34 • Baseline up to 28 days after last study drug administration 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.
Psychiatric disorders Initial insomnia	2.9% 1/35 • Baseline up to 28 days after last study drug administration 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.	0.00% 0/34 • Baseline up to 28 days after last study drug administration 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.
Psychiatric disorders Panic attack	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Renal and urinary disorders Dysuria	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/35 • Baseline up to 28 days after last study drug administration 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.	2.9% 1/34 • Baseline up to 28 days after last study drug administration 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.