A Single-center, Open Label Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis
Overview
- Phase
- Phase 4
- Intervention
- Secukinumab
- Conditions
- Psoriasis
- Sponsor
- Saakshi Khattri
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Psoriasis Area Severity Index (PASI) 90
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This will be a single-center, open-label clinical study to determine the efficacy and safety of secukinumab in the treatment of moderate to severe psoriasis vulgaris in skin of color (SOC) (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in SOC (and its change with secukinumab treatment) as well as the effect of secukinumab on post-inflammatory hyperpigmentation and quality of life in SOC.
Detailed 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 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.
Investigators
Saakshi Khattri
Assistant Professor, Dermatology
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- •Provide written, signed and dated informed consent prior to initiating any study-related activities.
- •Male or female ≥18 years of age at the time of screening
- •Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited to African Americans, Asians, Pacific Islanders and Hispanics
- •Clinical diagnosis of chronic plaque-type psoriasis of the body for at least 6 months prior to randomization
- •Moderate to severe plaque psoriasis at randomization as defined by: PASI≥12 AND BSA ≥ 10% AND IGA mod 2011 ≥ 3 (scale 0-4)
- •Candidate for systemic therapy, as defined by having psoriasis inadequately controlled by topical treatments and/or phototherapy and/or previous systemic therapy
- •Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While using investigational product and for at least 28 days after last application of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- •Must be in general good health as judged by the Investigator, based on medical history and physical examination. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
Exclusion Criteria
- •Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate, erythrodermic, pustular) or drug-induced psoriasis
- •Subjects with lighter skin as defined by Fitzpatrick Skin Types I-III
- •Subjects of European ancestry or other white ethnic group
- •Previous exposure to secukinumab or other biologic agent targeting IL-17A or IL-17RA
- •Ongoing use of prohibited treatments or lack of adherence to specified washout periods:
- •6 months for biologic drugs directly targeting IL-12/23 or IL-23, alefacept, and efalizumab
- •12 weeks for biologic agents other than the above (i.e. adalimumab, etanercept, infliximab)
- •4 weeks for other systemic psoriasis treatments (i.e. methotrexate, systemic steroids, retinoids, apremilast), and photochemotherapy
- •2 weeks for phototherapy (UVA, UVB)
- •2 weeks for topical psoriasis therapies
Arms & Interventions
Secukinumab
300mg subcutaneously
Intervention: Secukinumab
Outcomes
Primary Outcomes
Change in Psoriasis Area Severity Index (PASI) 90
Time Frame: Baseline, Week 16 and Week 24
Proportion of patients achieving ≥90% improvement in Psoriasis Area Severity Index (PASI) at week 16 compared to baseline (PASI90). PASI will be assessed at baseline and then at regular intervals until week 24.
Secondary Outcomes
- Change in erythema index (EI)(Baseline, Weeks 4, 12, 16, and 24)
- Change in patient-rated visual analog scale(Baseline, Weeks 4, 12, 16, and 24)
- Change in PASI 75(Baseline, Weeks 4, 12, 16, and 24)
- Change in PASI 90(Baseline, Weeks 4, 12, 16, and 24)
- Change in The Physician Global Assessment and Body Surface Area (PGAxBSA) score(Baseline and Week 16)
- Change in PASI 100(Baseline, Weeks 4, 12, 16, and 24)
- Change in Investigator Global Assessment (IGA) mod 2011(Weeks 12, 16, and 24)
- Change in the Dermatology Life Quality Index (DLQI)(Weeks 12, 16, and 24)
- Change in physician numeric rating scale (physician)(Baseline, Weeks 4, 12, 16, and 24)
- Change in melanin index (MI)(Weeks 4, 12, 16, 24)