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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01090063

Acronym

PPP

Enrollment

Registered

2010-03-19

Start date

2010-02-28

Completion date

2012-04-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Palmar Plantar Psoriasis

Keywords

Palmar Plantar Psoriasis

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.

Interventions

DRUGUstekinumab

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Pustule Count (if Present at Baseline) From Baseline to Week 24	Baseline, 24 weeks	Number of pustules present in each subject
Fissure Count (if Present at Baseline) From Baseline to Week 24	Baseline, 24 weeks	Number of discrete fissures on the hands and feet of each subject.
PGA Score Over Time From Baseline to Week 24	Baseline, 24 weeks	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.
Pain Visual Analog Scale From Baseline to Week 24	Baseline, 24 weeks	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	24 weeks	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.
Pruritus Visual Analog Scale From Baseline to Week 24	Baseline, 24 weeks	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).

Countries

United States

Participant flow

Recruitment details

Recruitment from Apr 2010 to Sept 2011 in the dermatology clinic of a tertiary care hospital.

Pre-assignment details

Washout of 2 weeks for topicals, 4 weeks for all other biologics and systemics prior to baseline dosage.

Participants by arm

Arm	Count
Main	24
Total	24

Withdrawals & dropouts

Period	Reason	FG000
Screen	Screen Failed	4
Treatment	Withdrawal by Subject	4

Baseline characteristics

Characteristic	Main
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	6 Participants
Age, Categorical Between 18 and 65 years	18 Participants
Age, Continuous	55 years STANDARD_DEVIATION 16
Region of Enrollment United States	24 participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	6 / 24
serious Total, serious adverse events	0 / 24

Outcome results

Primary

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

Time frame: 16 weeks

Population: Number of participants completing enrollment. Lost values carried forward as last observation carried forward

Arm	Measure	Value (NUMBER)
Main	Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.	0.375 percentage of participants

Secondary