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

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ClinicalTrials.gov Identifier: NCT03832738
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Psoriasis Skin Diseases Drug: JTE-451 Tablets Drug: Placebo Tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
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)
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: JTE-451 Dose 1
JTE-451 Tablets Dose 1 daily for 16 weeks.
Drug: JTE-451 Tablets
Active drug tablets containing JTE-451

Experimental: JTE-451 Dose 2
JTE-451 Tablets Dose 2 daily for 16 weeks.
Drug: JTE-451 Tablets
Active drug tablets containing JTE-451

Placebo Comparator: Placebo
Placebo Tablets daily for 16 weeks.
Drug: Placebo Tablets
Placebo tablets matching in appearance to the active drug tablets




Primary Outcome Measures :
  1. Proportion of subjects achieving a minimum 75% improvement from baseline in the psoriasis area and severity index (PASI-75) at Week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving PASI-50/PASI-75/PASI-90 [ Time Frame: Weeks 2, 4, 8, 12, 16 and 20 ]
  2. Change from baseline in Static Physician's Global Assessment (sPGA) score, used to determine the severity of subject's psoriatic lesion at a given time point using the following score: 0 (cleared), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe). [ Time Frame: Weeks 2, 4, 8, 12, 16 and 20 ]
  3. Number of adverse events [ Time Frame: 20 Weeks ]
  4. JTE-451 trough plasma concentrations [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832738


Contacts
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Contact: Yoshiro Masuda 609-919-9570 ClinicalTrials@akrospharma.com

Locations
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United States, California
Clinical Science Institute Recruiting
Santa Monica, California, United States, 90404
Advanced Dermatology and Skin Cancer Specialists Recruiting
Temecula, California, United States, 92592
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC Recruiting
Indianapolis, Indiana, United States, 46250
United States, Oklahoma
Central Sooner Research Recruiting
Norman, Oklahoma, United States, 73071
United States, South Dakota
Health Concepts Recruiting
Rapid City, South Dakota, United States, 57702
Canada, Manitoba
Wiseman Dermatology Research Inc. Recruiting
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center Recruiting
Barrie, Ontario, Canada, L4M 7G1
SKiN Health Recruiting
Cobourg, Ontario, Canada, K9A 0B3
Research Toronto Recruiting
Toronto, Ontario, Canada, M4W 2N2
K. Papp Clinical Research Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Diex Research Sherbrooke Inc. Recruiting
Sherbrooke, Quebec, Canada, J1L 0H8
Poland
Copernicus Podmiot Leczniczy Sp. z o.o., Oddzial Dermatologii Recruiting
Gdansk, Poland, 80-152
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo Recruiting
Kielce, Poland, 25-316
Centrum Nowoczesnych Terapii "Dobry Lekarz" Spolka z orgraniczona odpowiedzialnoscia Recruiting
Krakow, Poland, 31-011
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akeyjna Recruiting
Lodz, Poland, 90-242
Dermoklinika - Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak Recruiting
Lodz, Poland, 90-436
ETG Lublin Recruiting
Lublin, Poland, 20-412
Centrum Medyczne Grunwald Recruiting
Poznan, Poland, 60-369
Solumed Centrum Medyczne Recruiting
Poznan, Poland, 60-529
Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii Recruiting
Rzeszow, Poland, 35-055
ETG Siedlce Recruiting
Siedlce, Poland, 08-110
ETG Skierniewice Recruiting
Skierniewice, Poland, 96-100
Clinical Research Group Sp. z o.o. Recruiting
Warszawa, Poland, 01-142
Dorota Bystrzanowska "High-Med" Przychodnia Specjalistyczna Recruiting
Warszawa, Poland, 01-817
Carpe Diem Centrum Medycyny Estetycznej Recruiting
Warszawa, Poland, 02-661
ETG Warszawa Recruiting
Warszawa, Poland, 02-777
CITYCLINIC Przychodnia Psychologiczno-Lekarska Matusiak Spolka Partnerska Recruiting
Wroclaw, Poland, 50-566
DERMMEDICA Sp. z o.o. Recruiting
Wrocław, Poland, 51-318
Sponsors and Collaborators
Akros Pharma Inc.

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Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT03832738     History of Changes
Other Study ID Numbers: AE451-G-18-004
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Akros Pharma Inc.:
JTE-451
Psoriasis
Plaque psoriasis
IMPACT-PS

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous