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

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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.


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.
We found this trial at
2
sites
Rapid City, South Dakota 57702
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Rapid City, SD
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Norman, Oklahoma 73069
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Norman, OK
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