Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Tofacitinib ointment 20mg/g

Placebo ointment (Vehicle)

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic Dermatitis, Atopic Eczema, Eczema, topical treatment, skin diseases, tofacitinib, CP-690, 550, Janus Kinase inhibitor

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.
Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).

Exclusion Criteria:

Evidence of certain skin conditions/infections at baseline
Currently have atopic dermatitis on groin, genitals, palm or soles
Have certain laboratory abnormalities at baseline
Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception

Sites / Locations

SKiN Centre for Dermatology
The Centre for Dermatology
K. Papp Clinical Research
Innovaderm Research Inc.
Centre de Recherche Dermatologique du Quebec metropolitain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group A

Treatment B

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4

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.

Secondary Outcome Measures

Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4

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.

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

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.

Percent Change From Baseline in Body Surface Area (BSA) Efficacy 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.

Change From Baseline in the EASI Clinical Signs Severity Sum Score at 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.

Full Information

NCT ID

NCT02001181

First Posted

November 27, 2013

Last Updated

September 16, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02001181

Brief Title

Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

Official Title

A Phase 2a, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Pilot Efficacy, Safety, Tolerability, And Pharmacokinetics Of 2% Tofacitinib Ointment In Subjects With Mild To Moderate Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

Atopic Dermatitis, Atopic Eczema, Eczema, topical treatment, skin diseases, tofacitinib, CP-690, 550, Janus Kinase inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group A

Arm Type

Experimental

Arm Title

Treatment B

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tofacitinib ointment 20mg/g

Intervention Description

Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo ointment (Vehicle)

Intervention Description

Placebo ointment (vehicle) twice daily (BID) for 4 weeks

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4

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

Secondary Outcome Measure Information:

Title

Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4

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

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

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

Title

Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4

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

Title

Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka. Have a PGA score of 2 (mild) or 3 (moderate) at Day 1. Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles). Exclusion Criteria: Evidence of certain skin conditions/infections at baseline Currently have atopic dermatitis on groin, genitals, palm or soles Have certain laboratory abnormalities at baseline Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

SKiN Centre for Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 1Z2

Country

Canada

Facility Name

The Centre for Dermatology

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4B 1A5

Country

Canada

Facility Name

K. Papp Clinical Research

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Innovaderm Research Inc.

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2K 4L5

Country

Canada

Facility Name

Centre de Recherche Dermatologique du Quebec metropolitain

City

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

30556911

Citation

Purohit VS, Ports WC, Wang C, Riley S. Systemic Tofacitinib Concentrations in Adult Patients With Atopic Dermatitis Treated With 2% Tofacitinib Ointment and Application to Pediatric Study Planning. J Clin Pharmacol. 2019 Jun;59(6):811-820. doi: 10.1002/jcph.1360. Epub 2018 Dec 17.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921214&StudyName=Tofacitinib%20Ointment%20For%20Atopic%20Dermatitis%20%28Atopic%20Eczema%29

Description

To obtain contact information for a study center near you, click here.

Dermatitis, Atopic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial