This Study is Being Conducted to Evaluate the Safety, Tolerability, and Efficacy of KD025 Administered Orally for 16 Weeks to Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy.



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:3/8/2017
Start Date:August 2016

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Efficacy of KD025 in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy

This study is being conducted to evaluate the safety, tolerability, and efficacy of KD025 in
adult subjects with moderate to severe chronic plaque psoriasis.

This study will be performed in adult male and female subjects with moderate to severe
chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Study drug
will be orally administered in a double-blind fashion for 16 weeks in order to evaluate
efficacy through 16 weeks of treatment. Approximately 150 subjects will be randomly assigned
to 1 of 5 dose cohorts:

- 200 mg KD025 once daily (QD)

- 200 mg KD025 BID

- 400 mg KD025 QD

- 600 mg/day KD025 (administered as 400 mg in the morning and 200 mg in the evening)

- Placebo BID

Inclusion Criteria:

- Adult subjects between the ages of 18 and 65 years

- Able to provide written ICF prior to the performance of any study specific procedures

- Has a diagnosis of moderate to severe chronic plaque psoriasis and is a candidate for
systemic therapy or phototherapy

- 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

- Have adequate bone marrow function:

- Absolute neutrophil count (ANC) > 1500/mm3

- Hemoglobin > 9.0 g/dL

- Platelets > 100,000/mm3

- Have adequate safety laboratory values:

- Serum total bilirubin within normal limits (WNL)

- AST and ALT < 2 × upper limit of normal (ULN)

- Serum creatinine < 1.5 × ULN

- Female subjects of childbearing potential have a negative pregnancy test at
screening. Females of childbearing potential are defined as sexually mature women
without prior hysterectomy or who have had any evidence of menses in the past 12
months. However, women who have been amenorrheic for 12 or more months are still
considered to be of childbearing potential if the amenorrhea is possibly due to prior
chemotherapy, antiestrogens, or ovarian suppression

- Women of childbearing potential (i.e., menstruating women) must have a negative
urine pregnancy test (positive urine tests are to be confirmed by serum test)
documented within the 24-hour period prior to the first dose of study drug

- Sexually active women of childbearing potential enrolled in the study must agree
to use two forms of accepted methods of contraception during the course of the
study and for 3 months after their last dose of study drug. Effective birth
control includes (a) IUD plus one barrier method; (b) on stable doses of
hormonal contraception for at least 3 months (e.g., oral, injectable, implant,
transdermal) plus one barrier method; (c) 2 barrier methods. Effective barrier
methods are male or female condoms, diaphragms, and spermicides (creams or gels
that contain a chemical to kill sperm); or (d) a vasectomized partner

- For male patients who are sexually active and who are partners of premenopausal
women: agreement to use two forms of contraception as in criterion 5 above during the
treatment period and for at least 3 months after the last dose of study drug

- 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 high-dose corticosteroid (>10 mg of prednisone or equivalent) within 12 weeks
prior to or during the study, or immunosuppressive therapy within 4 weeks prior to
study entry

- Use of methotrexate, retinoids (such as acitretin), or calcineurin inhibitors (such
as 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, anti-TNFα, anti-IL-12 & -23,
within 3 months prior to study entry

- Has an active viral, fungal, or bacterial skin infection (other than nail fungal
infection).

- Is a pregnant or lactating woman

- Has a history of GI surgery including any 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 or 5 half-lives of the investigational drug (whichever is longer) of study entry

- Has a 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

- Regular and/or 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

- Has QTc(F) interval (QT interval data corrected using Fridericia's formula) of > 450
msec (average of 3 readings) during screening

- Has had exposure to KD025 or known allergy/sensitivity to KD025 within the last 6
months prior to study entry or any other ROCK-2 inhibitor

- History or presence of any of the following:

- ALT or AST > 2.0 × 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.)

- Renal disease and/or serum creatinine > 1.5 × ULN at screening
We found this trial at
15
sites
501 South 2nd Street
New Albany, Indiana 40202
Phone: 502-373-2849
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
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911 Park Avenue
New York, New York 10075
212-710-9855
Phone: 212-772-7242
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Brighton, Massachusetts 02135
Phone: 781-444-0900
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High Point, North Carolina 27262
Phone: 336-841-2040
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Indianapolis, Indiana 46256
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1900 Saint James Place
Katy, Texas 77056
Phone: 713-985-0210
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Los Angeles, California 90045
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Louisville, Kentucky 40202
Phone: 502-585-9059
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Nashville, Tennessee 37215
Phone: 615-383-9660
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Norfolk, Virginia 23507
Phone: 757-625-0151
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Phoenix, AZ
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Portland, Oregon 97210
Phone: 503-226-3376
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