A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

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NCT03963401

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Study Location
Emeritus Research
Melbourne, Victoria, 3124, Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
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

- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints.

- Active plaque psoriasis at screening and baseline.

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


- Non-plaque forms of psoriasis (with exception of nail psoriasis).


- History of autoimmune rheumatic disease other than PsA; also prior history of or
current, rheumatic inflammatory disease other than PsA.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Official Title  ICMJE A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
Brief Summary This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Drug: PF-06700841
    Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
  • Other: Placebo
    Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
Study Arms  ICMJE
  • Experimental: PF-06700841 60 mg once daily
    PF-06700841 60 mg once daily for 52 weeks
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 30 mg once daily
    PF-06700841 30 mg once daily for 52 weeks
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 10 mg once daily followed by 60 mg once daily
    PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 10 mg once daily followed by 30 mg once daily
    PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52
    Intervention: Drug: PF-06700841
  • Placebo Comparator: Placebo once daily followed by 60 mg once daily
    Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52
    Intervention: Other: Placebo
  • Placebo Comparator: Placebo once daily followed by 30 mg once daily
    Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52
    Intervention: Other: Placebo
Publications * Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 17, 2020)		217
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)		196
Estimated Study Completion Date  ICMJE January 12, 2021
Actual Primary Completion Date April 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints.
  • Active plaque psoriasis at screening and baseline.

Exclusion Criteria:

  • Non-plaque forms of psoriasis (with exception of nail psoriasis).
  • History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA.
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,   Bulgaria,   Czechia,   Estonia,   Hungary,   Lithuania,   Poland,   Russian Federation,   Serbia,   Slovakia,   Spain
Removed Location Countries Belarus
 
Administrative Information
NCT Number  ICMJE NCT03963401
Other Study ID Numbers  ICMJE B7931030
2018-004241-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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 June 2020

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