Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis
Status: | Terminated |
---|---|
Conditions: | Skin Cancer, Psoriasis, Skin and Soft Tissue Infections |
Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 12/16/2018 |
Start Date: | November 10, 2017 |
End Date: | October 29, 2018 |
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of JTE-051 Administered for 12 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR-PS)
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051
administered for 12 weeks in subjects with moderate to severe plaque psoriasis.
administered for 12 weeks in subjects with moderate to severe plaque psoriasis.
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) ≤38 at Visit 1.
Exclusion Criteria:
- Medical history of treatment failure to any systemic agents for plaque psoriasis;
- Prior exposure to more than one biologic agent treatment;
- 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);
- History of or at risk for destructive arthropathy (e.g., rapidly progressing
osteoarthritis, osteonecrosis, spontaneous osteonecrosis of the knee, subchondral
insufficiency fracture, hip dislocation and pathologic fracture) at Visit 1.
We found this trial at
13
sites
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318 2nd Street South
Nampa, Idaho 83651
Nampa, Idaho 83651
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