Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis

An Investigator-Initiated, Open-label Study Evaluating the Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis

NCT01090063•Tufts Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the short and long term safety and effectiveness of ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults between 18 and 85 years of age with palmar plantar psoriasis with well defined psoriatic plaques on the palms and/or soles with a Physician Global Assessment (PGA) of 3 or higher who are unresponsive to topical management. Pustules, fissures and psoriatic arthritis may be present but are not required.
•2. Adults in general good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination.
•3. Females of reproductive potential are eligible to participate in the study if they have a negative urine pregnancy test at screening and baseline and who are using 2 forms of effective birth control.
•4. Palmar/Plantar PGA of 3 or more

Exclusion Criteria

•1. Psoriasis patients without palm and/or sole psoriasis or a palmar/plantar PGA score of less than 3
•2. Patients younger than 18 and older than 85 years old.
•3. Evidence of skin conditions at the time of the screening visit (e.g. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
•4. Receipt of any investigational drugs within 4 weeks of study drug initiation
•5. Psoralens + UltraViolet A (PUVA) or oral systemic treatments within 4 weeks of study drug initiation.
•6. Biologics within 3 months of study initiation
•7. Ultraviolet B (UVB) therapy or topical steroids within 2 weeks of study drug initiation
•8. A prior history of tuberculosis, and/or a positive Purified Protein Derivative (PPD) skin test/Chest X-Ray (CXR) at screening without appropriate treatment. Treatment of latent Tuberculosis (TB) infections (for those with positive PPD tests) must be initiated prior to therapy.
•9. Receipt of live vaccines 1 month prior to or while in study
•10. Chronic hepatitis B or hepatitis C infection
+5 more criteria

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

February 1, 2010

Primary Completion Date

February 1, 2012

Completion Date

April 1, 2012

Last Updated

October 28, 2016

Enrollment

ACTUAL participants

Conditions

Moderate to Severe Palmar Plantar Psoriasis

Interventions

Ustekinumab

DRUG