Clinical trial NCT01090063: Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate to Severe Palmar Plantar Psoriasis
Keywords: Palmar Plantar Psoriasis
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Centocor, Inc.
First posted: 2010-03-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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 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
11. History of alcohol or drug abuse one year before and during the study.
12. Known Human Immunodeficiency Virus (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)

Primary outcomes:
measure: Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.
timeFrame: 16 weeks
Secondary outcomes:
measure: PGA Score Over Time From Baseline to Week 24
timeFrame: Baseline, 24 weeks
measure: Pustule Count (if Present at Baseline) From Baseline to Week 24
timeFrame: Baseline, 24 weeks
measure: Fissure Count (if Present at Baseline) From Baseline to Week 24
timeFrame: Baseline, 24 weeks
measure: Pruritus Visual Analog Scale From Baseline to Week 24
timeFrame: Baseline, 24 weeks
measure: Pain Visual Analog Scale From Baseline to Week 24
timeFrame: Baseline, 24 weeks
measure: Safety Outcome Measures
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Alice B Gottlieb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: