A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Kadmon Corporation, LLC

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.