A Double - Blind, Placebo Controlled Crossover Study to Evaluate The Efficacy and Tolerability of Stelara ™ (Ustekinumab) in The Treatment of Scalp Psoriasis
Overview
- Phase
- Phase 4
- Intervention
- Ustekinumab
- Conditions
- Scalp Psoriasis
- Sponsor
- Paul Steven Yamauchi, MD, PhD
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- s-PGA ( Scalp specific Physician Global Assessment) at Week 12
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Paul Steven Yamauchi, MD, PhD
Medical Director, Clinical Science Institute
Yamauchi, Paul Steven, M.D., Ph.D.
Eligibility Criteria
Inclusion Criteria
- •Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
- •Be 18 years of age or older at the time of consent; may be male or female.
- •Have had a diagnosis of plaque psoriasis at least 6 months prior to administration of study agent.
- •Presence of moderate or severe psoriasis on the body other than the scalp.
- •At least 30% of scalp affected with erythema, induration and desquamation and s-PGA score greater than or equal to
- •Be candidates for phototherapy or systemic treatment of psoriasis.
- •Women of childbearing potential and all men must be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue use of such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent.
- •Be able to adhere to protocol requirements and study visit schedule.
- •Must agree not to receive a live virus or live bacterial vaccination during the trial and 12 months after last study injection.
- •Must agree not to receive a BCG vaccination during the trial and up to 12 months after the last injection.
Exclusion Criteria
- •Subjects meeting any of the following criteria may not be enrolled in the study:
- •Currently have non-plaque forms of psoriasis (erythrodermic, guttate, or pustular).
- •Have current drug-induced psoriasis.
- •Presence of any skin conditions ( including scalp) other than psoriasis that would interfere with evaluations of the effect of study agents.
- •Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study.
- •Have used any therapeutic agent targeted at reducing IL-12 and/or IL-23, including but not limited to ustekinumab and ABT -
- •Have used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent, whatever is longer.
- •Have used any investigational drug within the previous 3 months or 5 times the half-life of the biological, whichever is longer.
- •Have ever received natalizumab or other agents that target alpha-4-integrin.
- •Have received phototherapy or any any systemic medications/treatments that could affect psoriasis or s-PGA/PASI evaluations ( including but not limited to, oral or injectable corticosteroids, retinoids,1,25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of administration of study agent.
Arms & Interventions
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
Intervention: Ustekinumab
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
Intervention: Placebo
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
Intervention: Ustekinumab
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
Intervention: Placebo
Outcomes
Primary Outcomes
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)
s-PGA (Scalp specific Physician Global Assessment) is a 7 point scale ranging from 0 (Clear = No signs of psoriasis ) to 6 (Severe = Very marked plaque elevation, scaling, and/or erythema)