Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

NCT02201524

Last updated date
Study Location
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 32505, 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.
Plaque Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.

2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).

3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).

4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).

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


1. Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
psoriasis.


2. 3. Have current drug induced psoriasis, eg, a new onset of psoriasis or an
exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial
drugs or lithium.


3. Have received any of the following treatment regimens specified in the timeframes
outlined below:


Within 9 months of first dose of study drug:


• Ustekinumab (Stelara).


Within 12 weeks of first dose of study drug:


• Any experimental therapy for psoriasis or rheumatoid arthritis.


Within 4 8 weeks of first dose of study drug:


- Biologic therapies for psoriasis have discontinuation periods determined from
approximately 5x half life of the respective biologic:


- 4 weeks: etanercept (Enbrel).


- 8 weeks: infliximab (Remicade), adalimumab (Humira).


Within 4 weeks of first dose of study drug:


- Systemic treatments other than biologics that could affect psoriasis (eg, oral or
injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid
derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine).


- Phototherapy and psoralen plus ultraviolet A therapy (PUVA).


- Other - intramuscular gold, immunization with any live virus vaccination (eg,
FluMist), herbal medications.


Within 2 weeks of first dose of study drug:


- Topical treatments that could affect psoriasis (eg, corticosteroids, tars,
keratolytics, anthralin, vitamin D analogs, and retinoids).


- Phototherapy with ultraviolet B (UVB) (narrowband or broadband).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
Official Title  ICMJE A Phase 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis
Brief Summary Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.
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 Plaque Psoriasis
Intervention  ICMJE
  • Drug: PF-04965842
    Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks
    Other Name: JAK1 inhibitor
  • Drug: PF-04965842
    Subjects will receive 400 mg PF 04965842 daily for 4 weeks
    Other Name: JAK1 inhibitor
  • Drug: PF-04965842
    Subjects will receive 200 mg PF 04965842 daily for 4 weeks
    Other Name: JAK1 inhibitor
  • Other: Placebo
    Subjects will receive placebo for 4 weeks
Study Arms  ICMJE
  • Experimental: Cohort 1
    200mg of PF-04965842 twice daily
    Intervention: Drug: PF-04965842
  • Experimental: Cohort 2
    400mg of PF-04965842 once daily
    Intervention: Drug: PF-04965842
  • Experimental: Cohort 3
    200mg of PF-04965842 once daily
    Intervention: Drug: PF-04965842
  • Placebo Comparator: Cohort 4
    Placebo comparator daily
    Intervention: Other: 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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 4, 2015)
59
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2014)
196
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.
  2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
  3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
  4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).

Exclusion Criteria:

  1. Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis.
  2. 3. Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
  3. Have received any of the following treatment regimens specified in the timeframes outlined below:

Within 9 months of first dose of study drug:

? Ustekinumab (Stelara).

Within 12 weeks of first dose of study drug:

? Any experimental therapy for psoriasis or rheumatoid arthritis.

Within 4 8 weeks of first dose of study drug:

  • Biologic therapies for psoriasis have discontinuation periods determined from approximately 5x half life of the respective biologic:
  • 4 weeks: etanercept (Enbrel).
  • 8 weeks: infliximab (Remicade), adalimumab (Humira).

Within 4 weeks of first dose of study drug:

  • Systemic treatments other than biologics that could affect psoriasis (eg, oral or injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine).
  • Phototherapy and psoralen plus ultraviolet A therapy (PUVA).
  • Other - intramuscular gold, immunization with any live virus vaccination (eg, FluMist), herbal medications.

Within 2 weeks of first dose of study drug:

  • Topical treatments that could affect psoriasis (eg, corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids).
  • Phototherapy with ultraviolet B (UVB) (narrowband or broadband).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02201524
Other Study ID Numbers  ICMJE B7451005
JAK-1 FOR PSORIASIS ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 August 2016

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