A Safety and Tolerability Study of KD025 Treatment in Subjects With Moderately Severe Psoriasis Vulgaris
Status: | Recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 11/8/2014 |
Start Date: | April 2014 |
A Phase 2a, Open-Label Study to Evaluate the Safety and Tolerability of KD025 Treatment in Subjects With Moderately Severe Psoriasis Vulgaris Who Have Failed First-Line Therapy
The primary objective is to assess the safety and tolerability of 200 mg of KD025
administered orally once daily for 28 days
administered orally once daily for 28 days
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.
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