Clinical trial NCT04571567: A Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Psoriasis
Skin of Color
Moderate
Severe
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Secukinumab is a recombinant, high-affinity, fully human immunoglobulin G1κ 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.
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Change in Psoriasis Area Severity Index (PASI) 90
timeFrame: Baseline, Week 16 and Week 24
Secondary outcomes:
measure: Change in PASI 75
timeFrame: Baseline, Weeks 4, 12, 16, and 24
measure: Change in PASI 90
timeFrame: Baseline, Weeks 4, 12, 16, and 24
measure: Change in PASI 100
timeFrame: Baseline, Weeks 4, 12, 16, and 24
measure: Change in Investigator Global Assessment (IGA) mod 2011
timeFrame: Weeks 12, 16, and 24
measure: Change in The Physician Global Assessment and Body Surface Area (PGAxBSA) score
timeFrame: Baseline and Week 16
measure: Change in melanin index (MI)
timeFrame: Weeks 4, 12, 16, 24
measure: Change in erythema index (EI)
timeFrame: Baseline, Weeks 4, 12, 16, and 24
measure: Change in physician numeric rating scale (physician)
timeFrame: Baseline, Weeks 4, 12, 16, and 24
measure: Change in patient-rated visual analog scale
timeFrame: Baseline, Weeks 4, 12, 16, and 24
measure: Change in the Dermatology Life Quality Index (DLQI)
timeFrame: Weeks 12, 16, and 24
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West Dermatolgy
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Saakshi Khattri, M.D.
role: PRINCIPAL_INVESTIGATOR
References: