Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-Line Therapy



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:December 2014
End Date:March 2016

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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

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.


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
We found this trial at
9
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Duncansville, Pennsylvania 16635
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Glendale, Arizona 85306
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Henderson, Nevada 89074
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High Point, North Carolina 27265
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Lake Charles, Louisiana 70605
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Santa Ana, California 92701
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Santa Ana, CA
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