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

NCT03832738 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AE451-G-18-004
• Study Type: interventional
• Target: 152
• Locations: 3 countries
• Sites: 33

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

Keywords

JTE-451; Psoriasis; Plaque psoriasis; IMPACT-PS

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)

  The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.

  End of Treatment (Up to 16 Weeks)

Secondary Outcomes (13)

• Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT

  End of Treatment (Up to 16 Weeks)

• Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT

  End of Treatment (Up to 16 Weeks)

• Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT

  End of Treatment (Up to 16 Weeks)

• Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT

  End of Treatment (Up to 16 Weeks)

• Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT

  End of Treatment (Up to 16 Weeks)

Study Arms (3)

JTE-451 Dose 1

EXPERIMENTAL

JTE-451 Tablets Dose 1 daily for 16 weeks.

Drug: JTE-451 Tablets

JTE-451 Dose 2

EXPERIMENTAL

JTE-451 Tablets Dose 2 daily for 16 weeks.

Drug: JTE-451 Tablets

Placebo

PLACEBO COMPARATOR

Placebo Tablets daily for 16 weeks.

Drug: Placebo Tablets

Interventions

JTE-451 Tablets DRUG

Active drug tablets containing JTE-451

JTE-451 Dose 1; JTE-451 Dose 2

Placebo Tablets DRUG

Placebo tablets matching in appearance to the active drug tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akros Pharma Inc.: lead

Study Sites (33)

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Advanced Dermatology and Skin Cancer Specialists

Temecula, California, 92592, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

SKiN Health

Cobourg, Ontario, K9A 0B3, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

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

Bydgoszcz, 85-094, Poland

Location

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

Gdansk, 80-152, Poland

Location

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, 25-316, Poland

Location

Centrum Nowoczesnych Terapii "Dobry Lekarz" Spolka z orgraniczona odpowiedzialnoscia

Krakow, 31-011, Poland

Location

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

Lodz, 90-242, Poland

Location

ETG Lodz

Lodz, 90-302, Poland

Location

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

Lodz, 90-436, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Centrum Medyczne Grunwald

Poznan, 60-369, Poland

Location

Solumed Centrum Medyczne

Poznan, 60-529, Poland

Location

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

Rzeszów, 35-055, Poland

Location

ETG Siedlce

Siedlce, 08-110, Poland

Location

ETG Skierniewice

Skierniewice, 96-100, Poland

Location

Clinical Research Group Sp. z o.o.

Warsaw, 01-142, Poland

Location

Dorota Bystrzanowska "High-Med" Przychodnia Specjalistyczna

Warsaw, 01-817, Poland

Location

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, 02-661, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-692, Poland

Location

ETG Warszawa

Warsaw, 02-777, Poland

Location

CITYCLINIC Przychodnia Psychologiczno-Lekarska Matusiak Spolka Partnerska

Wroclaw, 50-566, Poland

Location

DERMMEDICA Sp. z o.o.

Wroclaw, 51-318, Poland

Location

ETG Zamosc

Zamość, 22-400, Poland

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Kazuhiro Okamiya
• Organization: Akros Pharma Inc.

okamiya@akrospharma.com

609-919-6123

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 6, 2019
• Study Start: January 17, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: August 20, 2021
• Results First Posted: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); PL (21); CA (6)