A Study to Evaluate the Effectiveness of STELARA ™ (USTEKINUMAB) in the Treatment of Scalp Psoriasis

Part of paid clinical trials in Santa Monica, California.

Sponsor
Paul Steven Yamauchi, MD, PhD
Study ID
NCT01558310
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses
  • Placebo — DRUG
    Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses

Study Details

This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp specific physician assessments. The study will include approximately 30 subjects.

Key Dates

Start date
Aug 31, 2012
Status verified
Jul 2012
Primary completion
Oct 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52.The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses
  • Placebo Comparator: Group B
    Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses

Primary Outcome Measure

s-PGA ( Scalp specific Physician Global Assessment) at Week 12 [ Time Frame: Week 12 (8 weeks after the second of two SC doses of ustekinumab) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Science InstituteSanta MonicaCalifornia90404
PAUL YAMAUCHI, MD,PhD
[email protected]
310-828-8887
PAUL YAMAUCHI, MD,PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Santa Monica, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Clinical Science Institute· Santa Monica, CA

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