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

Primary Purpose

Moderate to Severe Palmar Plantar Psoriasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ustekinumab
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Palmar Plantar Psoriasis focused on measuring Palmar Plantar Psoriasis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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
  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)

Sites / Locations

  • Tufts Medical Center

Outcomes

Primary Outcome Measures

Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.

Secondary Outcome Measures

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.
Pustule Count (if Present at Baseline) From Baseline to Week 24
Number of pustules present in each subject
Fissure Count (if Present at Baseline) From Baseline to Week 24
Number of discrete fissures on the hands and feet of each subject.
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).
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).
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.

Full Information

First Posted
March 15, 2010
Last Updated
September 26, 2016
Sponsor
Tufts Medical Center
Collaborators
Centocor, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01090063
Brief Title
Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis
Acronym
PPP
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Centocor, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Palmar Plantar Psoriasis
Keywords
Palmar Plantar Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Other Intervention Name(s)
Stelara
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
PGA Score Over Time From Baseline to Week 24
Description
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.
Time Frame
Baseline, 24 weeks
Title
Pustule Count (if Present at Baseline) From Baseline to Week 24
Description
Number of pustules present in each subject
Time Frame
Baseline, 24 weeks
Title
Fissure Count (if Present at Baseline) From Baseline to Week 24
Description
Number of discrete fissures on the hands and feet of each subject.
Time Frame
Baseline, 24 weeks
Title
Pruritus Visual Analog Scale From Baseline to Week 24
Description
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).
Time Frame
Baseline, 24 weeks
Title
Pain Visual Analog Scale From Baseline to Week 24
Description
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).
Time Frame
Baseline, 24 weeks
Title
Safety Outcome Measures
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Adults in general good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination. 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. Palmar/Plantar PGA of 3 or more Exclusion Criteria: Psoriasis patients without palm and/or sole psoriasis or a palmar/plantar PGA score of less than 3 Patients younger than 18 and older than 85 years old. 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 Receipt of any investigational drugs within 4 weeks of study drug initiation Psoralens + UltraViolet A (PUVA) or oral systemic treatments within 4 weeks of study drug initiation. Biologics within 3 months of study initiation Ultraviolet B (UVB) therapy or topical steroids within 2 weeks of study drug initiation 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. Receipt of live vaccines 1 month prior to or while in study Chronic hepatitis B or hepatitis C infection History of alcohol or drug abuse one year before and during the study. Known Human Immunodeficiency Virus (HIV)-positive status or any other immune-suppressing disease. Any grade 3 or 4 adverse event, or laboratory toxicity, at the time of the screening visit or at any time during the study 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. Any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice B Gottlieb, MD, PhD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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