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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.

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ClinicalTrials.gov Identifier: NCT02852967
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: KD025 Drug: Placebo tablet Phase 2

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: KD025 200 mg QD (Once Daily)
200 mg KD025 QD (subjects will receive one KD025 200 mg and one matching placebo tablet in the morning and a matching placebo in the evening).
Drug: KD025
Other Name: SLx-2119

Experimental: KD025 200 mg BID (Twice Daily)
200 mg KD025 BID (subjects will receive one KD025 200 mg and one matching placebo tablet in the morning and KD025 200 mg in the evening).
Drug: KD025
Other Name: SLx-2119

Experimental: KD025 400 mg QD (Once Daily)
400 mg KD025 QD (subjects will receive two KD025 200 mg tablets in the morning and a matching placebo in the evening).
Drug: KD025
Other Name: SLx-2119

Experimental: KD025 600mg/day
600 mg/day KD025 (subjects will receive two KD025 200 mg tablets in the morning and one KD025 200 mg tablet in the evening).
Drug: KD025
Other Name: SLx-2119

Placebo Comparator: Placebo
Placebo (subjects will receive two matching placebo tablets in the morning and one matching placebo tablet in the evening).
Drug: Placebo tablet



Primary Outcome Measures :
  1. Psoriasis Area Severity Index (PASI) 75 [ Time Frame: 16 weeks ]
    To assess the number of subjects that reach PASI 75 after 16 weeks of dosing with various regimens of KD025 compared to placebo.

  2. Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 16 weeks ]
    To evaluate the safety and tolerability of KD025 at various regimens when administered for 16 weeks to subjects with moderate to severe chronic plaque psoriasis.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852967


Locations
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United States, Arizona
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States, 85032
United States, California
University of California, Irvine - Dermatology Clinical Research Center
Irvine, California, United States, 92697
Dermatology Research Associates
Los Angeles, California, United States, 90045
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Indiana
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, United States, 46256
Dermatology Specialists Research
New Albany, Indiana, United States, 40202
United States, Kentucky
Dermatology Specialists Research
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Metro Boston Clinical Partners
Brighton, Massachusetts, United States, 02135
United States, New Jersey
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States, 08520
United States, New York
Sadick Research Group
New York, New York, United States, 10075
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Suzanne Bruce and Associates
Katy, Texas, United States, 77056
Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
Sponsors and Collaborators
Kadmon Corporation, LLC

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Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02852967     History of Changes
Other Study ID Numbers: KD025-211
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kadmon Corporation, LLC:
Skin Diseases
Auto-Immune Diseases
Plaque
Dermatology

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases