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Trial record 1 of 1 for:    NCT03915496
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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 : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 22, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date February 26, 2020
Estimated Study Start Date  ICMJE March 31, 2020
Estimated Primary Completion Date June 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
  • Changes from baseline in gene expression [ Time Frame: Baseline, Week 12 ]
    Response based on mRNA and/or PCR gene arrays in skin lesions
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Changes from baseline in gene expression [ Time Frame: Baseline, Week 12 ]
    Response based on mRNA and/or PCR gene arrays in skin lesions
  • Changes from baseline in cellular (T-call 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
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: PF-04965842 200 mg
    PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks
  • Drug: PF-04965842 100 mg
    PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks
  • Drug: Placebo
    Placebo administered as two tablets to be taken orally once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: PF-04965842 200 mg
    Intervention: Drug: PF-04965842 200 mg
  • Experimental: PF-04965842 100 mg
    Intervention: Drug: PF-04965842 100 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
51
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 23, 2021
Estimated Primary Completion Date June 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03915496
Other Study ID Numbers  ICMJE B7451037
JADE MOA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP