Irvine, California 92697

  • Psoriasis Vulgaris

Purpose:

The primary objective is to assess the safety and tolerability of 200 mg of KD025 administered orally once daily for 28 days


Criteria:

Inclusion Criteria: - Diagnosis of moderately severe plaque psoriasis that has been stable for 6 months and has failed at least one line of systemic therapy and is a candidate for additional systemic therapy. - Had a PASI of ≥12 - At least 10% of body surface area that is affected by plaque psoriasis. - Willing to avoid tanning devices or sun bathing. - Willing to forgo systemic and topical treatments for psoriasis during the course of the study. - Adequate bone marrow function - Negative urine pregnancy test (for women of childbearing potential) - Agree to use a highly effective method of birth control (< 1% per year failure rate) during the study and for 1 month after the termination of the study. - Willing to complete all study measurements and assessments in compliance with the protocol. Exclusion Criteria: - Non-plaque or drug-induced psoriasis - Currently using corticosteroid or immunosuppressive therapy except for Class 5 or weaker topical corticosteroids to the face, groin, or scalp - Using any topical therapy except for the following: 1. Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry 2. Immunosuppressive therapies for 4 weeks prior to study entry 3. Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry 4. Biologic therapies for 3 months prior to study entry. - Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening. - Viral, fungal, or bacterial skin infection. - Pregnant or lactating woman. - Currently participating in another study with an investigational drug or within 28 days of study entry - History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study - History or presence of any of the following: 1. Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) at screening 2. Renal disease and/or serum creatinine > 1.5xULN at screening - Has QTc(f) intervals of > 450 msec at the screening or pre-dose ECG - Subject is receiving any drugs known to prolong the QTc interval, including any anti-arrhythmic medications within 2 weeks prior to screening - Subject is receiving any drug that is a strong CYP enzyme inhibitor - Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme - Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor.


NCT ID:

NCT02106195


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Irvine, California 92697
United States

Brian Swasdibutra
Phone: 949-824-2319
Email: bswasdib@uci.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 17, 2021

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