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Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Last updated on December 6, 2019

FOR MORE INFORMATION
Study Location
CINME Centro de Investigaciones Metabolicas
Caba, , C1027APP Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dermatitis, Atopic Dermatitis, Eczema, Skin Diseases, Genetic Skin Diseases, Inborn Genetic Diseases, Eczematous Skin Diseases, Hypersensitivity, Immediate Hypersensitivity, Immune System Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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: BSA10%, IGA 3, EASI 16, Pruritus NRS 4)

- Recent history of inadequate response or inability to tolerate topical AD treatments
or require systemic treatments for AD control

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT03627767
Pfizer
Recruiting
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

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Descriptive Information
Brief Title  ICMJE Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
Official Title  ICMJE A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS
Brief SummaryB7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
Detailed DescriptionResponder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dermatitis
  • Dermatitis, Atopic
  • Eczema
  • Skin Diseases
  • Skin Diseases, Genetic
  • Genetic Diseases, Inborn
  • Skin Diseases, Eczematous
  • Hypersensitivity
  • Hypersensitivity, Immediate
  • Immune System Diseases
Intervention  ICMJE
  • Drug: PF-04965842 100 mg
    PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
  • Drug: PF-04965842 200 mg
    PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
  • Drug: Placebo
    Placebo, administered as two tablets to be taken orally once daily for 40 weeks
Study Arms  ICMJE
  • Experimental: PF-04965842 100 mg QD
    Double-blind randomized treatment following open label run-in period.
    Intervention: Drug: PF-04965842 100 mg
  • Experimental: PF-04965842 200 mg QD
    Double-blind randomized treatment following open label run-in period.
    Intervention: Drug: PF-04965842 200 mg
  • Placebo Comparator: Placebo QD
    Double-blind randomized treatment following open label run-in period.
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
1235
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
1370
Estimated Study Completion Date  ICMJE August 27, 2020
Estimated Primary Completion DateAugust 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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: BSA10%, IGA 3, EASI 16, Pruritus NRS 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Germany,   Israel,   Italy,   Latvia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03627767
Other Study ID Numbers  ICMJE B7451014
JADE REGIMEN ( Other Identifier: Alias Study Number )
2018-000501-23 ( EudraCT Number )
REGIMEN ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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