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

Phase 4

Waitlist Available

Led By PAUL S YAMAUCHI, MD,PhD

Research Sponsored by Paul Steven Yamauchi, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 (8 weeks after the second of two sc doses of ustekinumab)

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Drug Has Already Been Approved

Summary

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.

Eligible Conditions

Psoriasis
Plaque Psoriasis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 (8 weeks after the second of two sc doses of ustekinumab)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 (8 weeks after the second of two sc doses of ustekinumab)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 (8 weeks after the second of two sc doses of ustekinumab) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

s-PGA ( Scalp specific Physician Global Assessment) at Week 12

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group AActive Control2 Interventions

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

Group II: Group BPlacebo Group2 Interventions

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

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