Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Plaque Psoriasis
Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2020
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT03832738
Start Date
January 17 2019
End Date
March 13 2020
Last Update
August 20 2021
Active Locations (33)
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1
Clinical Science Institute
Santa Monica, California, United States, 90404
2
Advanced Dermatology and Skin Cancer Specialists
Temecula, California, United States, 92592
3
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
4
Central Sooner Research
Norman, Oklahoma, United States, 73071