A Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Psoriasis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Secukinumab is a recombinant, high-affinity, fully human immunoglobulin G1? monoclonal antibody targeting IL-17A. Phase III studies have demonstrated the safety and efficacy of secukinumab in the treatment of moderate-to-severe psoriasis when dosed as 300mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 300mg every 4 weeks.12 Secukinumab is FDA approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. The study treatment consists of secukinumab 300mg by subcutaneous injection. Each 300mg dose is given as two subcutaneous injections of secukinumab 150mg, 1mg liquid formulation in a pre-filled syringe. Secukinumab pre-filled syringes 150 mg will be supplied by Novartis.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints that occurs in diverse ethnic groups worldwide. There is paucity of data on the use of topical and systemic medications in dark-skinned individuals. Unique issues in skin of color (SOC) populations, including increa...
Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints that occurs in diverse ethnic groups worldwide. There is paucity of data on the use of topical and systemic medications in dark-skinned individuals. Unique issues in skin of color (SOC) populations, including increased risk of dyspigmentation (hyperpigmentation and hypopigmentation), make studies dedicated to darker skin types essential for treatment of psoriasis in these populations. This will be a single-center, open-label clinical study to evaluate the efficacy and safety of secukinumab in adults with skin types IV-VI with moderate to severe plaque psoriasis. A total of 20 subjects (ages 18+, male and female, BSA ?10%, PASI Score ? 12, IGA mod 2011 score ? 3) are expected to complete this study, which will run for a total of up to 28 weeks. The study consists of two periods: Screening (from 0 to 4 weeks) and open-label treatment period (24 weeks). During the second period, a total of 20 subjects will receive secukinumab 300mg subcutaneously. Those who meet all of the inclusion/exclusion criteria and are enrolled in the study will receive study drug for the entire treatment period.
Tracking Information
- NCT #
- NCT04571567
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Andrew F Alexis, M.D. MPH Icahn School of Medicine at Mount Sinai
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