Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 51 of 154 for:    Dermatitis, Atopic, 8

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915496
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 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
Estimated Study Start Date : December 2, 2019
Estimated Primary Completion Date : April 24, 2021
Estimated Study Completion Date : April 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




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-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

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03915496     History of Changes
Other Study ID Numbers: B7451037
JADE MOA ( Other Identifier: Alias Study Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
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

Layout table for additional information
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:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases