Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
Status: | Recruiting |
---|---|
Conditions: | Skin Cancer, Psoriasis, Skin and Soft Tissue Infections |
Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 2/8/2019 |
Start Date: | January 17, 2019 |
End Date: | July 2020 |
Contact: | Yoshiro Masuda |
Email: | ClinicalTrials@akrospharma.com |
Phone: | 609-919-9570 |
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)
Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects
with moderate to severe plaque psoriasis.
with moderate to severe plaque psoriasis.
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.
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