Moderate to Severe Palmar Plantar Psoriasis Clinical Trial
— PPPOfficial title:
An Investigator-Initiated, Open-label Study Evaluating the Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis
| Verified date | January 2013 |
| Source | Tufts Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | April 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Tufts Medical Center | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Tufts Medical Center | Centocor, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16. | 16 weeks | No | |
| Secondary | PGA Score Over Time From Baseline to Week 24 | Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear. | Baseline, 24 weeks | No |
| Secondary | Pustule Count (if Present at Baseline) From Baseline to Week 24 | Number of pustules present in each subject | Baseline, 24 weeks | No |
| Secondary | Fissure Count (if Present at Baseline) From Baseline to Week 24 | Number of discrete fissures on the hands and feet of each subject. | Baseline, 24 weeks | No |
| Secondary | Pruritus Visual Analog Scale From Baseline to Week 24 | Patient's score on the questionnaire of "how itchy are you", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome). | Baseline, 24 weeks | No |
| Secondary | Pain Visual Analog Scale From Baseline to Week 24 | Patient's score on the questionnaire of "how much pain are you experiencing from your disease of your hands and feet", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome). | Baseline, 24 weeks | No |
| Secondary | Safety Outcome Measures | All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends. | 24 weeks | Yes |