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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis, Skin Diseases

In brief

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

Key facts

Study ID

NCT03358290

Run by

Akros Pharma Inc.

People needed

13

Starts

2017-11-10

Expected to finish

2018-10-29

Last updated by the study team

2021-08-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) ≤40 at Visit 1.

You may not qualify if…

• Medical history of treatment failure to any systemic agents for plaque psoriasis;
• 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);

Where it is running

• First OC Dermatology — Fountain Valley, California, United States
• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States
• University of South Florida - Hospital — Tampa, Florida, United States
• Atlanta Dermatology Vein and Research Center LLC — Alpharetta, Georgia, United States
• Advanced Medical Research, PC — Sandy Springs, Georgia, United States
• Advanced Clinical Research - Dermatology Center of Canyon County — Nampa, Idaho, United States
• Clinical Research Advantage, Inc. — Evansville, Indiana, United States
• Kansas City Dermatology P.A. — Overland Park, Kansas, United States
• Forest Hills Dermatology Group — Forest Hills, New York, United States
• Radiant Research, Inc. — Anderson, South Carolina, United States
• Clinical Research Center of the Carolinas — Charleston, South Carolina, United States
• Dermatology Treatment and Research Center — Dallas, Texas, United States
• Karma Clinical Trials — St. John's, Newfoundland and Labrador, Canada
• Mediprobe Research Inc. — London, Ontario, Canada
• Lynderm Research Inc. — Markham, Ontario, Canada
• David Gratton's Private Practice — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.