Summary

for people ages 18-65 (full criteria)
at Irvine, California and other locations
study started

Description

Summary

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

Official Title

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

Details

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

Keywords

PsoriasisSkin DiseasesAuto-Immune DiseasesPlaqueDermatologyKD025KD025 200 mg QD (Once Daily)KD025 200 mg BID (Twice Daily)KD025 400 mg QD (Once Daily)KD025 600mg/day

Eligibility

You can join if…

Open to people ages 18-65

  • 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 at screening and prior to the first dose of study drug, confirmed at Week 1 (Day 1)
  • >/= 10% PASI body surface area involvement at screening and prior to the first dose of study drug, confirmed at Week 1 (Day 1)
  • 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

You CAN'T join if...

  • 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 systemic corticosteroids within 12 weeks prior to study entry
  • Use topical corticosteroids except to the face, groin, or scalp
  • 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
  • Current use of an inhibitor or inducer of CYP3A4
  • 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

Locations

  • University of California, Irvine - Dermatology Clinical Research Centeraccepting new patients
    IrvineCalifornia92697United States
  • Dermatology Research Associatesaccepting new patients
    Los AngelesCalifornia90045United States

Details

Status
accepting new patients
Start Date
Sponsor
Kadmon Corporation, LLC
ID
NCT02852967
Phase
Phase 2
Study Type
Interventional
Last Updated