Moderate to Severe Palmar Plantar PsoriasisPPPNCT01090063
Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis
A study testing Ustekinumab in people with Moderate to Severe Palmar Plantar Psoriasis, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Moderate to Severe Palmar Plantar Psoriasis
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-Initiated, Open-label Study Evaluating the Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis
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.
- Being tested
- Ustekinumab
- Keywords
- Palmar Plantar Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called Stelara
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.
Measured: 16 weeks
Secondary outcomes (6)
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.
Measured: Baseline, 24 weeks
Pustule Count (if Present at Baseline) From Baseline to Week 24
Number of pustules present in each subject
Measured: Baseline, 24 weeks
Fissure Count (if Present at Baseline) From Baseline to Week 24
Number of discrete fissures on the hands and feet of each subject.
Measured: Baseline, 24 weeks
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).
Measured: Baseline, 24 weeks
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).
Measured: Baseline, 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Palmar Plantar PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Sponsor
- Investigators
- Alice B Gottlieb, MD, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090063
- Sponsor's protocol ID
- Palmar Plantar Psoriasis
- Acronym
- PPP
- Status last verified
- Sep 2016
- First submitted
- 15 Mar 2010
- Last updated
- 28 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated, Open-label Study Evaluating the Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis
- ClinicalTrials.gov ID
- NCT01090063
- Acronym / sponsor ID
- PPP / Palmar Plantar Psoriasis
- Keywords
- Palmar Plantar Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Posted 11 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: StelaraDosing 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. | Drug | – |
Primary outcome
Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.
Time frame: 16 weeks
6 secondary outcomes
PGA Score Over Time From Baseline to Week 24
Time frame: Baseline, 24 weeks
Pustule Count (if Present at Baseline) From Baseline to Week 24
Time frame: Baseline, 24 weeks
Fissure Count (if Present at Baseline) From Baseline to Week 24
Time frame: Baseline, 24 weeks
Pruritus Visual Analog Scale From Baseline to Week 24
Time frame: Baseline, 24 weeks
Pain Visual Analog Scale From Baseline to Week 24
Time frame: Baseline, 24 weeks
Safety Outcome Measures
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice B Gottlieb, MD, PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ustekinumab in people with Moderate to Severe Palmar Plantar Psoriasis, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.