A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of JTE-451 Administered for 16 Weeks in Subjects with Moderate to Severe Plaque Psoriasis (IMPACT-PS) - IMPACT-PS

Akros Pharma Inc.0 个研究点目标入组 150 人开始时间: 2019年3月18日最近更新: 2020年12月7日

适应症

试验速览

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•1. Male or female, =18 and =70 years of age at the time of Visit 1 (Screening Visit)
•2. Have a history of moderate to severe plaque psoriasis for at least 6 months prior to Visit 1
•3. Subjects with moderate to severe plaque psoriasis covering =10% BSA, with a PASI =12 and sPGA score =3 at Visit 1 and Visit 2 (baseline)
•4. Body Mass Index (BMI) =40 kg/m^2 at Visit 1
•5. Females may participate in the study if they are either surgically sterile, or post-menopausal or if of childbearing potential, use appropriate contraception methods described in the protocol for the duration of the study and for at least 30 days after the last dose of study drug.
•Note: female subjects must not donate eggs for the duration of the study and for at least 12 weeks after the last dose of study drug.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. History of the discontinuation of biologic therapies (including marketed and investigational drugs) directly targeting IL-17A, IL-17A/F, IL-17 receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the Investigator’s judgement
•Note: If subjects discontinued these therapies due to other reasons (e.g., safety, preference of other medication, cost, insurance coverage, remission), the subjects may participate in the study according to the Investigator’s judgment.
•2. Prior exposure to ROR-? inhibitors
•3. Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1
•Note: Subjects with psoriatic arthritis may participate in the study if criteria for cutaneous severity of psoriasis, as well as all other study restrictions required by the protocol are met.
•4. History or presence of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug-induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1
•5. Does not meet all protocol-specified laboratory test criteria or study restrictions, including previous/concomitant medication restriction criteria

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