Clinical trial NCT03832738: Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Psoriasis
Skin Diseases
Keywords: JTE-451
Psoriasis
Plaque psoriasis
IMPACT-PS
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-06
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)
timeFrame: End of Treatment (Up to 16 Weeks)
Secondary outcomes:
measure: Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Percent Change From Baseline in Psoriasis Body Surface Area (BSA) at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Change From Baseline in the Skindex-16 Overall Score at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Change From Baseline in the Skindex-16 Symptom Scale Scores at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Change From Baseline in the Skindex-16 Emotions Scale Scores at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Change From Baseline in the Skindex-16 Functioning Scale Scores at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Change From Baseline in Itch Numeric Rating Scale (NRS) at EOT
timeFrame: End of Treatment (Up to 16 Weeks)
measure: Number of Subjects With Treatment-emergent Adverse Events
timeFrame: Follow-up (Up to 20 Weeks)
measure: JTE-451 Trough Plasma Concentrations at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Temecula
country: United States
facility: Advanced Dermatology and Skin Cancer Specialists
state: California
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Cobourg
country: Canada
facility: SKiN Health
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 1 im. Dr. A. Jurasza w Bydgoszczy, Klinika Dermatologii, Chorob Prenoszonych Droga Plciowa
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o.o., Oddzial Dermatologii
city: Kielce
country: Poland
facility: Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
city: Krakow
country: Poland
facility: Centrum Nowoczesnych Terapii "Dobry Lekarz" Spolka z orgraniczona odpowiedzialnoscia
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akeyjna
city: Lodz
country: Poland
facility: ETG Lodz
city: Lodz
country: Poland
facility: Dermoklinika - Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
city: Lublin
country: Poland
facility: ETG Lublin
city: Poznan
country: Poland
facility: Centrum Medyczne Grunwald
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii
city: Siedlce
country: Poland
facility: ETG Siedlce
city: Skierniewice
country: Poland
facility: ETG Skierniewice
city: Warszawa
country: Poland
facility: Clinical Research Group Sp. z o.o.
city: Warszawa
country: Poland
facility: Dorota Bystrzanowska "High-Med" Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: Carpe Diem Centrum Medycyny Estetycznej
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Warszawa
country: Poland
facility: ETG Warszawa
city: Wroclaw
country: Poland
facility: CITYCLINIC Przychodnia Psychologiczno-Lekarska Matusiak Spolka Partnerska
city: Wrocław
country: Poland
facility: DERMMEDICA Sp. z o.o.
city: Zamosc
country: Poland
facility: ETG Zamosc
Study officials:
References: