Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 24 for:    PF-04965842

Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-2)

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: NCT03575871
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: PF-04965842 100 mg Drug: PF-04965842 200 mg Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : August 14, 2019
Estimated Study Completion Date : August 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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

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

Placebo Comparator: Placebo Drug: Placebo
Placebo, administered as two tablets to be taken orally once daily for 12 weeks




Primary Outcome Measures :
  1. Change from Baseline; Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 12 ]
    Response based on IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of >=2 points at Week 12

  2. Change from Baseline; Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 12 ]
    Response based on 75% improvement from baseline on EASI (EASI-75) at Week 12


Secondary Outcome Measures :
  1. Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]
    Response based on at least 4 points improvement in the severity of pruritus NRS from baseline at Weeks 2, 4 and 12

  2. Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) [ Time Frame: Baseline, Week 12 ]
    Change from baseline in PSAAD at Week 12

  3. Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 8, Week 16 (follow-up) ]
    Response based on at least 4 points improvement in the severity of pruritus NRS from baseline at Weeks 8 and 16 (follow-up)

  4. Prutitus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Day 15 ]
    Time to achieve a 4-point improvement in severity of pruritus NRS from baseline to Day 15

  5. Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 (follow-up) ]
    Response based on 75% improvement from baseline in EASI (EASI-75) at Week 2, Week 4, Week 8, Week 16 (follow-up)

  6. Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 (follow-up) ]
    Response based on the IGA of clear (0) or almost clear (1) and >=2 point reduction from baseline at Week 2, Week 4, Week 8, Week 16 (follow-up)



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:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 years of age or older with a minimum body weight of 40 kg
  • Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
  • Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

  • Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
  • Prior treatment with JAK inhibitors
  • Other active nonAD inflammatory skin diseases or conditions affecting skin
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
  • Pregnant or breastfeeding women, or 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): NCT03575871


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

  Show 116 Study Locations
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: NCT03575871     History of Changes
Other Study ID Numbers: B7451013
MONO-2 ( Other Identifier: Alias Study Number )
2018-001136-21 ( EudraCT Number )
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 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