Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

NCT02780167

Last updated date
Study Location
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.

- Must have the following atopic dermatitis criteria:

1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.

2. Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.

3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).

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


- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,


- Infected with hepatitis B or hepatitis C viruses.


- Have evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)


- Have received any of the following treatment regiments specified in the timeframes
outlined below:


Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
of first dose of study drug: Participation in other studies involving investigational
drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
attenuated live vaccine.


Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
(NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
booth/parlor.


Within 1 week of first dose of study drug: Topical treatments that could affect atopic
dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
Official Title  ICMJE A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOSE-RANGING, STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-04965842 IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Brief Summary Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: PF-04965842
    10 mg of PF-04965842 QD for 12 weeks
  • Drug: PF-04965842
    30 mg of PF-04965842 QD for 12 weeks
  • Drug: PF-04965842
    100 mg of PF-04965842 QD for 12 weeks
  • Drug: PF-04965842
    200 mg of PF-04965842 QD for 12 weeks
  • Drug: Placebo
    Placebo QD for 12 weeks
Study Arms  ICMJE
  • Experimental: Cohort 1
    10 mg of PF-04965842 QD
    Intervention: Drug: PF-04965842
  • Experimental: Cohort 2
    30 mg of PF-04965842 QD
    Intervention: Drug: PF-04965842
  • Experimental: Cohort 3
    100 mg of PF-04965842 QD
    Intervention: Drug: PF-04965842
  • Experimental: Cohort 4
    200 mg of PF-04965842 QD
    Intervention: Drug: PF-04965842
  • Placebo Comparator: Cohort 5
    placebo QD
    Intervention: Drug: Placebo
Publications * Gooderham MJ, Forman SB, Bissonnette R, Beebe JS, Zhang W, Banfield C, Zhu L, Papacharalambous J, Vincent MS, Peeva E. Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2019 Dec 1;155(12):1371-1379. doi: 10.1001/jamadermatol.2019.2855. Erratum in: JAMA Dermatol. 2020 Jan 1;156(1):104.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2018)
269
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2016)
250
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
  • Must have the following atopic dermatitis criteria:

    1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
    2. Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
    3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).

Exclusion Criteria:

  • History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
  • Infected with hepatitis B or hepatitis C viruses.
  • Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
  • Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Hungary,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02780167
Other Study ID Numbers  ICMJE B7451006
2015-005513-72 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2019

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