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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 32505 United States
Contact
1-800-718-1021
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).

NCT02201524
Pfizer
Terminated
Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

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Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
A Phase 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Plaque Psoriasis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
59
September 2015
September 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT02201524
B7451005
JAK-1 FOR PSORIASIS ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2016

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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