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Tofacitinib Ointment For Chronic Plaque Psoriasis

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis Vulgaris, Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6
months prior to Baseline

- At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA)
on the trunk and limbs (excluding palms, soles, and nails)

- If received certain treatments, should be off treatment for a minimum period of time
(washout)

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 or drug-induced psoriasis

- Require treatment with or cannot stop medication(s) prohibited during the study

- Have certain laboratory abnormalities at Baseline

- Current or history of certain infections

- Females who are pregnant, breastfeeding, or are of childbearing potential not using
highly effective contraception

NCT01831466
Pfizer
Completed
Tofacitinib Ointment For Chronic Plaque Psoriasis

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Tofacitinib Ointment For Chronic Plaque Psoriasis
A Phase 2b, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Efficacy, Safety, Local Tolerability And Pharmacokinetics Of 2 Dose Strengths And 2 Regimens Of Tofacitinib Ointment In Subjects With Chronic Plaque Psoriasis.
The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Psoriasis Vulgaris
  • Psoriasis
  • Drug: tofacitinib ointment 20 mg/g
    tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
  • Drug: tofacitinib ointment 10 mg/g
    tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
  • Drug: placebo ointment (vehicle)
    placebo ointment (vehicle) BID (twice daily) for 12 weeks
  • Drug: tofacitinib ointment 20 mg/g
    tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
  • Drug: tofacitinib ointment 10 mg/g
    tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
  • Drug: placebo ointment (vehicle)
    placebo ointment (vehicle) QD (once daily) for 12 weeks
  • Experimental: Treatment Group A
    Intervention: Drug: tofacitinib ointment 20 mg/g
  • Experimental: Treatment Group B
    Intervention: Drug: tofacitinib ointment 10 mg/g
  • Placebo Comparator: Treatment Group C
    Intervention: Drug: placebo ointment (vehicle)
  • Experimental: Treatment Group D
    Intervention: Drug: tofacitinib ointment 20 mg/g
  • Experimental: Treatment Group E
    Intervention: Drug: tofacitinib ointment 10 mg/g
  • Placebo Comparator: Treatment Group F
    Intervention: Drug: placebo ointment (vehicle)
Papp KA, Bissonnette R, Gooderham M, Feldman SR, Iversen L, Soung J, Draelos Z, Mamolo C, Purohit V, Wang C, Ports WC. Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial. BMC Dermatol. 2016 Oct 3;16(1):15.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
476
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline
  • At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails)
  • If received certain treatments, should be off treatment for a minimum period of time (washout)

Exclusion Criteria:

  • Currently have non-plaque forms of psoriasis or drug-induced psoriasis
  • Require treatment with or cannot stop medication(s) prohibited during the study
  • Have certain laboratory abnormalities at Baseline
  • Current or history of certain infections
  • Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Poland,   United States
France
 
NCT01831466
A3921082
2012-005645-20 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

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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