Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis

NCT ID: NCT03832738

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-17
• Study Completion Date: 2020-03-13

Brief Summary

Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.

Conditions

Plaque Psoriasis; Psoriasis; Skin Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JTE-451 Dose 1

JTE-451 Tablets Dose 1 daily for 16 weeks.

Group Type: EXPERIMENTAL

JTE-451 Tablets

Intervention Type: DRUG

Active drug tablets containing JTE-451

JTE-451 Dose 2

JTE-451 Tablets Dose 2 daily for 16 weeks.

Group Type: EXPERIMENTAL

JTE-451 Tablets

Intervention Type: DRUG

Active drug tablets containing JTE-451

Placebo

Placebo Tablets daily for 16 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Tablets

Intervention Type: DRUG

Placebo tablets matching in appearance to the active drug tablets

Interventions

JTE-451 Tablets

Active drug tablets containing JTE-451

Intervention Type: DRUG

Placebo Tablets

Placebo tablets matching in appearance to the active drug tablets

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akros Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Science Institute

Santa Monica, California, United States

Advanced Dermatology and Skin Cancer Specialists

Temecula, California, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Central Sooner Research

Norman, Oklahoma, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Health Concepts

Rapid City, South Dakota, United States

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

SKiN Health

Cobourg, Ontario, Canada

Research Toronto

Toronto, Ontario, Canada

K. Papp Clinical Research

Waterloo, Ontario, Canada

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Szpital Uniwersytecki nr 1 im. Dr. A. Jurasza w Bydgoszczy, Klinika Dermatologii, Chorob Prenoszonych Droga Plciowa

Bydgoszcz, , Poland

Copernicus Podmiot Leczniczy Sp. z o.o., Oddzial Dermatologii

Gdansk, , Poland

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, , Poland

Centrum Nowoczesnych Terapii "Dobry Lekarz" Spolka z orgraniczona odpowiedzialnoscia

Krakow, , Poland

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akeyjna

Lodz, , Poland

ETG Lodz

Lodz, , Poland

Dermoklinika - Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak

Lodz, , Poland

ETG Lublin

Lublin, , Poland

Centrum Medyczne Grunwald

Poznan, , Poland

Solumed Centrum Medyczne

Poznan, , Poland

Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii

Rzeszów, , Poland

ETG Siedlce

Siedlce, , Poland

ETG Skierniewice

Skierniewice, , Poland

Clinical Research Group Sp. z o.o.

Warsaw, , Poland

Dorota Bystrzanowska "High-Med" Przychodnia Specjalistyczna

Warsaw, , Poland

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, , Poland

Royalderm Agnieszka Nawrocka

Warsaw, , Poland

ETG Warszawa

Warsaw, , Poland

CITYCLINIC Przychodnia Psychologiczno-Lekarska Matusiak Spolka Partnerska

Wroclaw, , Poland

DERMMEDICA Sp. z o.o.

Wroclaw, , Poland

ETG Zamosc

Zamość, , Poland

Countries

United States; Canada; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AE451-G-18-004

Identifier Type: -

Identifier Source: org_study_id