This trial is active, not recruiting.

Condition psoriasis vulgaris
Treatment kd025
Phase phase 2
Sponsor Kadmon Corporation, LLC
Start date December 2014
End date March 2016
Trial size 38 participants
Trial identifier NCT02317627, KD025-206


This study is being done to evaluate the safety, tolerability, activity, pharmacokinetics (PK), and daily dose regimen of KD025 administered orally for 12 weeks to subjects with psoriasis vulgaris who have failed at least one line of systemic therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
KD025 will be orally administered to subjects at 400 mg once daily for 12 weeks
kd025 SLx-2119
KD025 will be orally administered to subjects at 200mg twice daily for 12 weeks
kd025 SLx-2119
KD025 will be orally administered to subjects at 400mg twice daily for 12 weeks
kd025 SLx-2119

Primary Outcomes

Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
time frame: 12 weeks

Secondary Outcomes

Decrease in Psoriasis Area and Severity Index (PASI)
time frame: 12 weeks
Changes in Physicians Global Assessment (PGA)
time frame: 12 weeks
Changes in Dermatology Life Quality Index (DLQI)
time frame: 12 weeks
Pharmacokinetics (PK) of KD025 (Cmax, Tmax, AUC[0-24hr], AUCinf, and elimination t1/2)
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Able to provide written informed consent prior to the performance of any study specific procedures - Has a diagnosis of moderately severe plaque psoriasis that has been moderately stable for 6 months and has failed at least one line of systemic or phototherapy and is a candidate for additional systemic therapy - Has a PASI of ≥ 12 within the 24-hour period prior to the first dose of study drug - Has at least 10% of body surface area that is affected by plaque psoriasis within the 24-hour period prior to the first dose of study drug - Willing to avoid tanning devices - Willing to forgo other 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) documented within the 24-hour period prior to the first dose of study drug - Must 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. Effective birth control includes implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner - Willing to complete all study measurements and assessments in compliance with the protocol Exclusion Criteria: - Has non-plaque or drug-induced (antimalarials, lithium) psoriasis (If subject is taking angiotensin II receptor blockers or beta blockers doses must be stable for 6 months prior to study entry) - Use of corticosteroid or immunosuppressive therapy within 4 weeks prior to study entry except for Class 5 or weaker topical corticosteroids or immunosuppressive therapies to the face, groin, or scalp. - Use of methotrexate, acitretin, or cyclosporine within 4 weeks prior to study entry - Using phototherapy within 4 weeks prior to study entry - Using biologic therapies, including antibodies to IL-17, within 3 months prior to study entry - Has concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening - Has viral, fungal, or bacterial skin infection - Is a pregnant or lactating woman - History of gastrointestinal (GI) surgery including bariatric surgery, or any gastrointestinal condition that might interfere with drug absorption - Currently participating in another study with an investigational drug or within 28 days of study entry - Has 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 (such as poorly controlled psychiatric disease or coronary artery disease) - Regular and excessive use of alcohol within the 2 years prior to study entry defined as alcohol intake > 14 drinks per week in a man or > 7 drinks per week in a woman. Approximately 10 g of alcohol equals one "drink" unit. One unit equals 1 ounce of distilled spirits, one 12-ounce beer, or one 4-ounce glass of wine - History or presence of any of the following: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 × the upper limit of normal (ULN) at screening. (Subjects with an isolated AST elevation of any magnitude, or a ratio of AST:ALT > 1.5 should be interviewed regarding use of alcohol, have levels repeated and participation in the study should be discussed with the medical monitor.) 2. Renal disease and/or serum creatinine > 1.5 × ULN at screening - Has QTc(F) interval (QT interval data corrected using Fridericia's formula) of > 450 msec at the screening or predose ECG - Has had previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor

Additional Information

Official title A Phase 2, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-Line Therapy
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Kadmon Corporation, LLC.