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

Last updated on May 18, 2018

FOR MORE INFORMATION
Study Location
Clinical Research Center of Alabama
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
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.

NCT02780167
Pfizer
Completed
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

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Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
April 4, 2017
March 9, 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Germany,   Hungary,   United States
 
 
NCT02780167
B7451006
2015-005513-72 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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