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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01090063
First received: March 15, 2010
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Moderate to Severe Palmar Plantar Psoriasis
Drug: Ustekinumab

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigator-Initiated, Open-label Study Evaluating the Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PGA Score Over Time From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Pustule Count (if Present at Baseline) From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    Number of pustules present in each subject

  • Fissure Count (if Present at Baseline) From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    Number of discrete fissures on the hands and feet of each subject.

  • Pruritus Visual Analog Scale From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    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).

  • Pain Visual Analog Scale From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    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).

  • Safety Outcome Measures [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 26
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ustekinumab
    Dosing will consist of a 45mg subcutaneous injection for patients weighing less than 100 kg and a 90 mg subcutaneous injection for patients whose weight is greater than 100 kg. Dosing will begin on week 0 followed by subsequent dosing on week 4 and week 16.
    Other Name: Stelara
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090063

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Centocor, Inc.
Investigators
Principal Investigator: Alice B Gottlieb, MD, PhD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01090063     History of Changes
Other Study ID Numbers: Palmar Plantar Psoriasis
Study First Received: March 15, 2010
Results First Received: August 13, 2012
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Palmar Plantar Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 20, 2014