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

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ClinicalTrials.gov Identifier: NCT02317627
Recruitment Status : Completed
First Posted : December 16, 2014
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Cohort 1
KD025 will be orally administered to subjects at 400 mg once daily for 12 weeks
Drug: KD025
Other Name: SLx-2119

Experimental: Cohort 2
KD025 will be orally administered to subjects at 200mg twice daily for 12 weeks
Drug: KD025
Other Name: SLx-2119

Experimental: Cohort 3
KD025 will be orally administered to subjects at 400mg twice daily for 12 weeks
Drug: KD025
Other Name: SLx-2119




Primary Outcome Measures :
  1. Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 weeks ]
    To evaluate the safety and tolerability of three daily dose regimens of KD025 for 12 weeks in subjects with psoriasis vulgaris who failed first-line therapy


Secondary Outcome Measures :
  1. Decrease in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ]
    To assess the amount of decrease, in Psoriasis Area and Severity Index (PASI) in subjects after 12 weeks of dosing with KD025

  2. Changes in Physicians Global Assessment (PGA) [ Time Frame: 12 weeks ]
    To assess changes in PGA

  3. Changes in Dermatology Life Quality Index (DLQI) [ Time Frame: 12 weeks ]
    To assess changes in DLQI

  4. Pharmacokinetics (PK) of KD025 (Cmax, Tmax, AUC[0-24hr], AUCinf, and elimination t1/2) [ Time Frame: 12 weeks ]
    To evaluate the following pharmacokinetic parameters: Cmax, Tmax, AUC[0-24hr], AUCinf, and elimination t1/2


Other Outcome Measures:
  1. Changes in Cytokine Expression (changes in cytokine expression in blood and punch biopsy) [ Time Frame: 12 weeks ]
    To evaluate the changes in cytokine expression in blood and punch biopsy after 12 weeks of treatment with KD025

  2. Changes in Extent of Steatosis (assessed by liver ultrasound) [ Time Frame: 12 weeks ]
    To evaluate changes in the extent of steatosis assessed by liver ultrasound after 12 weeks of dosing with KD025



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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:

  • 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

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): NCT02317627


Locations
United States, Arizona
Arrowhead Health Centers
Glendale, Arizona, United States, 85306
United States, California
Southern California Dermatology, Inc.
Santa Ana, California, United States, 92701
United States, Louisiana
Shondra L. Smith
Lake Charles, Louisiana, United States, 70605
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Nevada
Clinical Studies Group, LLC
Henderson, Nevada, United States, 89074
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Metroplex Clinical Research Center (MCRC)
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Kadmon Corporation, LLC

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02317627     History of Changes
Other Study ID Numbers: KD025-206
First Posted: December 16, 2014    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: March 2016

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