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Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis (JADE MOA)

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ClinicalTrials.gov Identifier: NCT03915496
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: PF-04965842 200 mg Drug: PF-04965842 100 mg Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE MECHANISM OF ACTION OF ABROCITINIB MONOTHERAPY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
Actual Study Start Date : June 18, 2020
Actual Primary Completion Date : November 16, 2021
Actual Study Completion Date : November 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-04965842 200 mg Drug: PF-04965842 200 mg
PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks
Experimental: PF-04965842 100 mg Drug: PF-04965842 100 mg
PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo administered as two tablets to be taken orally once daily for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline in atopic dermatitis biomarkers in lesional and non-lesional skin [ Time Frame: Baseline, Week 12 ]
    Response based on biomarkers for general inflammation (MMP12), hyperplasia (K16), Th2 immune response (CCL17, CCL18, CCL26), and Th22 immune response (S100A8, S100A9, S100A12)


Secondary Outcome Measures :
  1. Changes from baseline in gene expression [ Time Frame: Baseline, Week 12 ]
    Response based on mRNA and/or PCR gene arrays in skin lesions

  2. Changes from baseline in cellular (T-cell and dendritic cell) inflammation markers [ Time Frame: Baseline, Week 12 ]
    Response based on IHC evaluation of cellular (T-cells and dendritic cells) markers in skin biopsies

  3. Changes from baseline in epidermal hyperplasia markers [ Time Frame: Baseline, Week 12 ]
    Responses based on IHC evaluation of epidermal hyperplasia markers (thickness, K16, and Ki67) in skin biopsies

  4. Changes from baseline in blood biomarkers for inflammation and immune response [ Time Frame: Baseline, Week 12 ]
    Response based on OLINK proteomic microassay for inflammation and immune response in serum

  5. Changes from baseline in T-cell lymphocyte subset populations [ Time Frame: Baseline, Week 12 ]
    Response based on T-cell lymphocyte subset populations in blood using flow cytometry

  6. Changes from baseline in pruritus and its correlation to immunohistochemistry and genetic markers [ Time Frame: Baseline, Week 12 ]
    Response based on at least 4 points improvement in the severity of Peak Pruritus numerical rating scale and change in immunohistochemistry and genetic markers in lesional skin


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of chronic moderate-to-severe atopic dermatitis (AD) for at least 1 year
  • Recent history of inadequate response to medicated topical therapy for AD or required systemic therapy to control disease
  • Moderate-to-severe AD defined as affected BSA at least 10%, IGA at least 3, EASI at least 16, Peak Pruritus NRS at least 4

Exclusion Criteria:

  • A current or pat medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction
  • Currently have active forms of other inflammatory skin diseases, i.e. not AD, or have evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment
  • Participants who have received prior treatment with any systemic JAK inhibitors
  • Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication within specified time frames prior to the first dose of study medication, including topical treatments that could affect AD
  • Pregnant or breastfeeding women or sexually-active women of childbearing potential who are unwilling to use contraception
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915496


Locations
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United States, California
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
Keck School of Medicine of USC - IDS Pharmacy
Los Angeles, California, United States, 90033
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
United States, Florida
Olympian Clinical Research
Largo, Florida, United States, 33770
ForCare Clinical Research
Tampa, Florida, United States, 33613
United States, Indiana
The Indiana Clinical Trials Center, PC - Dermatology Research
Plainfield, Indiana, United States, 46168
United States, Michigan
Wayne Health - Wayne State Dermatology
Dearborn, Michigan, United States, 48124
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Canada, Alberta
Beacon Dermatology
Calgary, Alberta, Canada, T3E 0B2
Canada, Quebec
Innovaderm Research, Inc.
Montreal, Quebec, Canada, H2X 2V1
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03915496    
Other Study ID Numbers: B7451037
JADE MOA ( Other Identifier: Alias Study Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
atopic dermatitis
atopic eczema
eczema
JAK
janus kinase
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Abrocitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action