Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR-PS)

Akros Pharma

Status and phase: Terminated; Phase 2

Conditions: Skin Diseases; Plaque Psoriasis

Treatments: Drug: JTE-051; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03358290

AE051-G-16-007

Details and patient eligibility

About

Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1
• Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;
• Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;
• Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;
• Body Mass Index (BMI) ≤40 at Visit 1.

Exclusion criteria

• Medical history of treatment failure to any systemic agents for plaque psoriasis;
• Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1;
• Presence or history 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;
• History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2;
• History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 5 patient groups

JTE-051 Dose 1

Experimental group

Description:

One dose of study drug by mouth daily for 12 weeks

Treatment:

Drug: JTE-051

JTE-051 Dose 2

Experimental group

Description:

One dose of study drug by mouth daily for 12 weeks

Treatment:

Drug: JTE-051

JTE-051 Dose 3

Experimental group

Description:

One dose of study drug by mouth daily for 12 weeks

Treatment:

Drug: JTE-051

JTE-051 Dose 4

Experimental group

Description:

One dose of study drug by mouth daily for 12 weeks

Treatment:

Drug: JTE-051

Placebo

Experimental group

Description:

One dose of study drug by mouth daily for 12 weeks

Treatment:

Drug: Placebo