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

NCT04571567 | Completed Phase 4 FDA Drug

• 2 other identifiers: GCO 18-2408CAIN457AUS16T
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Skin of Color; Moderate; Severe

Outcome Measures

Primary Outcomes (1)

• Change in Psoriasis Area Severity Index (PASI) 90

  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.

  Baseline, Week 16 and Week 24

Secondary Outcomes (10)

• Change in PASI 75

  Baseline, Weeks 4, 12, 16, and 24

• Change in PASI 90

  Baseline, Weeks 4, 12, 16, and 24

• 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 Physician Global Assessment and Body Surface Area (PGAxBSA) score

  Baseline and Week 16

Study Arms (1)

Secukinumab

EXPERIMENTAL

300mg subcutaneously

Drug: Secukinumab

Interventions

Secukinumab DRUG

Each 300mg dose is given as two subcutaneous injections of secukinumab 150mg, 1mg liquid formulation in a pre-filled syringe.

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• months for biologic drugs directly targeting IL-12/23 or IL-23, alefacept, and efalizumab
• weeks for biologic agents other than the above (i.e. adalimumab, etanercept, infliximab)
• weeks for other systemic psoriasis treatments (i.e. methotrexate, systemic steroids, retinoids, apremilast), and photochemotherapy
• weeks for phototherapy (UVA, UVB)
• 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

Sponsors & Collaborators

• Saakshi Khattri: lead

Study Sites (1)

Mount Sinai West Dermatolgy

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

Psoriasis; Lymphoma, Follicular

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Saakshi Khattri, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Dermatology

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: October 1, 2020
• Study Start: December 2, 2019
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Anyone who wishes to access the data.To achieve aims in the approved proposal.OtherUnknown at this time.

Locations

US (1)