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Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

Last updated on June 7, 2018

FOR MORE INFORMATION
Study Location
Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
Rogers, Arkansas, 72758 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Plaque Psoriasis
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

- Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months
prior to Baseline/Day 1 (prior to first dose of study drug)

- Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe")
at Baseline/Day 1 (prior to first dose of study drug)

- Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at
Baseline/Day 1 (prior to first dose of study drug)

- Considered by dermatologist investigator to be a candidate for systemic therapy or
phototherapy 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

- Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
psoriasis, with the exception of nail psoriasis which is allowed

- Have evidence of skin conditions (eg, eczema) at the time of screening or baseline
visit that would interfere with the evaluation of psoriasis

- Cannot discontinue systemic therapies and/or topical therapies for the treatment of
psoriasis and cannot discontinue phototherapy (UVB or PUVA)

- Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).

- Have taken Apremilast (Otezla) within 3 months of first dose of study drug.

- Have undergone treatment with tofacitinib within 3 months of first dose.

NCT02969018
Pfizer
Completed
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

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Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Plaque Psoriasis
  • Drug: PF-06700841
  • Other: Placebo
  • Experimental: PF-06700841 60 mg followed by 30 mg once daily
    4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 60 mg followed by 10 mg once daily
    4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 60mg once daily followed by 100mg once weekly
    4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 60mg once daily followed by placebo once daily
    4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 30mg once daily
    4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 30mg once daily followed by 10mg once daily
    4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 30mg once daily followed by 100mg once weekly
    4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
    Intervention: Drug: PF-06700841
  • Placebo Comparator: Placebo
    12 weeks once daily placebo
    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.
 
Active, not recruiting
185
March 23, 2018
March 23, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
  • Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
  • Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
  • Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:

  • Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
  • Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
  • Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
  • Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
  • Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
  • Have undergone treatment with tofacitinib within 3 months of first dose.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Poland,   United States
 
 
NCT02969018
B7931004
2016-004049-96 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

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