Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis (IMPACT-PS)

Akros Pharma

Status and phase: Completed; Phase 2

Conditions: Psoriasis; Skin Diseases; Plaque Psoriasis

Treatments: Drug: JTE-451 Tablets; Drug: Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT03832738

AE451-G-18-004

Details and patient eligibility

About

Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.

Enrollment: 152 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have had a history of moderate to severe plaque psoriasis for at least 6 months prior to Visit 1;
• Subjects with moderate to severe plaque psoriasis covering ≥10% body surface area (BSA), with a psoriasis area and severity index (PASI) ≥12 and static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2

Exclusion criteria

• History of discontinuation of biologic therapies (including marketed and investigational drugs) directly targeting Interleukin (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 judgment;
• Prior exposure to retinoid-related orphan receptor (ROR)-γ inhibitors;
• Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (e.g., clinically-significant eczema or severe acne) at Visit 1;
• History or presence of itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin within 12 months prior to Visit 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 3 patient groups, including a placebo group

JTE-451 Dose 1

Experimental group

Description:

JTE-451 Tablets Dose 1 daily for 16 weeks.

Treatment:

Drug: JTE-451 Tablets

JTE-451 Dose 2

Experimental group

Description:

JTE-451 Tablets Dose 2 daily for 16 weeks.

Treatment:

Drug: JTE-451 Tablets

Placebo

Placebo Comparator group

Description:

Placebo Tablets daily for 16 weeks.

Treatment:

Drug: Placebo Tablets