A Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-Vā¦ (NCT04571567) | Clinical Trial Compass
CompletedPhase 4
A Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis
United States20 participantsStarted 2019-12-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provide written, signed and dated informed consent prior to initiating any study-related activities.
* Male or female ā„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: PASIā„12 AND BSA ā„ 10% AND IGA mod 2011 ā„ 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;ā¦