Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis

Study Purpose

Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1 - Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2; - Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2; - Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2; - Body Mass Index (BMI) ≤38 at Visit 1.

Exclusion Criteria:

  • - Medical history of treatment failure to any systemic agents for plaque psoriasis; - Prior exposure to more than one biologic agent treatment; - Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1; - Presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1; - History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2; - History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis); - History of or at risk for destructive arthropathy (e.g., rapidly progressing osteoarthritis, osteonecrosis, spontaneous osteonecrosis of the knee, subchondral insufficiency fracture, hip dislocation and pathologic fracture) at Visit 1.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03358290
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Akros Pharma Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis, Skin Diseases

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

First OC Dermatology, Fountain Valley, California

Status

Recruiting

Address

First OC Dermatology

Fountain Valley, California, 92708

Site Contact

609-919-9570

Fremont, California

Status

Recruiting

Address

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538

Site Contact

609-919-9570

University of South Florida - Hospital, Tampa, Florida

Status

Recruiting

Address

University of South Florida - Hospital

Tampa, Florida, 33612

Site Contact

609-919-9570

Alpharetta, Georgia

Status

Recruiting

Address

Atlanta Dermatology Vein and Research Center LLC

Alpharetta, Georgia, 30022

Site Contact

609-919-9570

Advanced Medical Research, PC, Sandy Springs, Georgia

Status

Recruiting

Address

Advanced Medical Research, PC

Sandy Springs, Georgia, 30328

Site Contact

609-919-9570

Nampa, Idaho

Status

Recruiting

Address

Advanced Clinical Research - Dermatology Center of Canyon County

Nampa, Idaho, 83651

Site Contact

609-919-9570

Clinical Research Advantage, Inc., Evansville, Indiana

Status

Recruiting

Address

Clinical Research Advantage, Inc.

Evansville, Indiana, 47714

Site Contact

609-919-9570

Kansas City Dermatology P.A., Overland Park, Kansas

Status

Recruiting

Address

Kansas City Dermatology P.A.

Overland Park, Kansas, 66215-2309

Site Contact

609-919-9570

Forest Hills Dermatology Group, Forest Hills, New York

Status

Not yet recruiting

Address

Forest Hills Dermatology Group

Forest Hills, New York, 11375

Site Contact

609-919-9570

Radiant Research, Inc., Anderson, South Carolina

Status

Recruiting

Address

Radiant Research, Inc.

Anderson, South Carolina, 29621

Site Contact

609-919-9570

Charleston, South Carolina

Status

Recruiting

Address

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407

Site Contact

609-919-9570

Dallas, Texas

Status

Recruiting

Address

Dermatology Treatment and Research Center

Dallas, Texas, 75230

Site Contact

609-919-9570

International Sites

David Gratton's Private Practice, Montreal, Quebec, Canada

Status

Recruiting

Address

David Gratton's Private Practice

Montreal, Quebec, H3H 1V4

Site Contact

609-919-9570

Karma Clinical Trials, Saint John's, Newfoundland and Labrador, Canada

Status

Not yet recruiting

Address

Karma Clinical Trials

Saint John's, Newfoundland and Labrador, A1A 4Y3

Site Contact

609-919-9570

Mediprobe Research Inc., London, Ontario, Canada

Status

Recruiting

Address

Mediprobe Research Inc.

London, Ontario, N5X 2P1

Site Contact

609-919-9570

Lynderm Research Inc., Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research Inc.

Markham, Ontario, L3P 1X2

Site Contact

609-919-9570

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.