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

NCT ID: NCT01090063

Last Updated: 2016-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Stelara

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice B Gottlieb, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

Palmar Plantar Psoriasis

Identifier Type: -

Identifier Source: org_study_id