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

NCT01090063 | Completed Results

• 1 other identifier: Palmar Plantar Psoriasis
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Palmar Plantar Psoriasis

Keywords

Palmar Plantar Psoriasis

Outcome Measures

Primary Outcomes (1)

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

  16 weeks

Secondary Outcomes (6)

• PGA Score Over Time From Baseline to Week 24

  Baseline, 24 weeks

• Pustule Count (if Present at Baseline) From Baseline to Week 24

  Baseline, 24 weeks

• Fissure Count (if Present at Baseline) From Baseline to Week 24

  Baseline, 24 weeks

• Pruritus Visual Analog Scale From Baseline to Week 24

  Baseline, 24 weeks

• Pain Visual Analog Scale From Baseline to Week 24

  Baseline, 24 weeks

Interventions

Ustekinumab DRUG

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.

Also known as: Stelara

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tufts Medical Center: lead
• Centocor, Inc.: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Alice Gottlieb
• Organization: Tufts Medical Center

Agottlieb@tuftsmedicalcenter.org

617-636-7462

Study Officials

• Alice B Gottlieb, MD, PhD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 19, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 28, 2016
• Results First Posted: March 11, 2013

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)