A Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis

Saakshi Khattri

Status and phase

Completed

Phase 4

Conditions

Psoriasis

Treatments

Drug: Secukinumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04571567

CAIN457AUS16T (Other Identifier)

GCO 18-2408

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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
Subjects unwilling to limit exposure to UV light
Use of other investigational drugs within 5 half-lives prior to randomization
Pregnant/nursing women or women of child-bearing potential unwilling to use appropriate method of contraception
Diagnosis of other ongoing skin disease or skin infection that may interfere with the treatment and/or examination of psoriasis lesions
Current significant medical problems or laboratory abnormalities that, in the opinion of the investigator, would put the patient at significant risk by participating in the study
Previous history of or current infection with hepatitis C, hepatitis B, or HIV
Active systemic infection during the 2 weeks prior to randomization
Evidence of tuberculosis infection (indeterminate or positive quantiferon gold) at screening. Subject may be enrolled if full tuberculosis workup has been completed in the 12 weeks preceding randomization and patient has been started on appropriate treatment at least 4 weeks prior to randomization
Malignancy with the past 5 years, with the exception of basal cell carcinoma, actinic keratosis, Bowen's disease of the skin, carcinoma in situ of the cervix(removed) or non-invasive malignant color polyps (removed)
History of allergy to any component of the IP