Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kadmon Corporation, LLC

Criteria

Inclusion Criteria:

• Able to provide written informed consent prior to the performance of any study specific procedures

• Diagnosis of moderately severe plaque psoriasis that has been moderately stable for 6 months and failed at least 1 line of systemic or phototherapy and is a candidate for additional systemic therapy

• PASI of ≥ 12 within the 24-hour period prior to the first dose of study drug

• At least 10% of body surface area 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: absolute neutrophil count > 1500/mm^3; hemoglobin > 9.0 g/dL; platelets > 100,000/mm^3

• Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug

• 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 included 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:

• Non-plaque or drug-induced (antimalarials, lithium) psoriasis (If subject is taking angiotensin II receptor blockers or beta blockers doses had to 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

• Use of phototherapy within 4 weeks prior to study entry

• Use of biologic therapies, including antibodies to IL-17, within 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

• History of gastrointestinal (GI) surgery including bariatric surgery, or any GI condition that might interfere with drug absorption

• 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 (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 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

• QTc(F) interval (QT interval data corrected using Fridericia's formula) > 450 msec at the screening or predose ECG

• Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor