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

Condition(s) targeted: Moderate to Severe Palmar Plantar Psoriasis

Intervention: Ustekinumab (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Tufts Medical Center

Official(s) and/or principal investigator(s):
Alice B Gottlieb, MD, PhD, Principal Investigator, Affiliation: Tufts Medical Center

Overall contact:
Nicole M Dumont, Phone: 617 636 7462, Email: ndonovan1@tuftsmedicalcenter.org

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.

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.

Secondary outcome:

PGA score over time from baseline to week 24

Pustule count (if present at baseline) from baseline to week 24

Fissure count (if present at baseline) from baseline to week 24

Pruritus Visual Analog Scale from baseline to week 24

Pain Visual Analog Scale from baseline to week 24

Safety Outcome Measures

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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 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. PUVA or oral systemic treatments within 4 weeks of study drug initiation.

6. Biologics within 3 months of study initiation

7. UVB therapy or topical steroids within 2 weeks of study drug initiation

8. A prior history of tuberculosis, and/or a positive PPD skin test/CXR at screening without appropriate treatment. Treatment of latent 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

11. History of alcohol or drug abuse one year before and during the study.

12. Known HIV-positive status or any other immune-suppressing disease.

13. Any grade 3 or 4 adverse event, or laboratory toxicity, at the time of the screening visit or at any time during the study

14. Presence of a grade 3 or 4 infection <30 days prior to the screening visit, between the screening visit and the first day of treatment on study, or any time during the study that in the opinion of the Investigator would preclude participation in the study.

15. Any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)

Nicole M Dumont, Phone: 617 636 7462, Email: ndonovan1@tuftsmedicalcenter.org

Tufts Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Nicole M Dumont, Phone: 617-636-7462, Email: ndonovan1@tuftsmedicalcenter.org
Alice B Gottlieb, MD, PhD, Principal Investigator
Paul F Lizzul, MD, PhD, MBA, Sub-Investigator

Starting date: February 2010
Last updated: July 6, 2011