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A Safety and Tolerability Study of KD025 Treatment in Subjects With Moderately Severe Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT02106195
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:
The primary objective is to assess the safety and tolerability of 200 mg of KD025 administered orally once daily for 28 days

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a, Open-Label Study to Evaluate the Safety and Tolerability of KD025 Treatment in Subjects With Moderately Severe Psoriasis Vulgaris Who Have Failed First-Line Therapy
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: KD025
KD025 200 mg (two 100 mg capsules) orally once daily for 28 days
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: 28 days ]
    To evaluate the safety and tolerability of 200 mg of KD025 administered orally once daily for 28 days in subjects with Psoriasis


Secondary Outcome Measures :
  1. Decrease in Psoriasis Area and Severity Index (PASI) [ Time Frame: 28 days ]
    To assess the decreases, if any, in PASI in all subjects after 28 days of dosing with 200 mg of KD025


Other Outcome Measures:
  1. Improvement in Physicians Global Assessment (PGA) [ Time Frame: 8 weeks ]
    To achieve improvement in PGA

  2. Change In Cytokine Expression [ Time Frame: 28 days ]
    Change in cytokine expression in punch biopsy after 28 days of treatment 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:

  • Diagnosis of moderately severe plaque psoriasis that has been stable for 6 months and has failed at least one line of systemic therapy and is a candidate for additional systemic therapy.
  • Had a PASI of ≥12
  • At least 10% of body surface area that is affected by plaque psoriasis.
  • Willing to avoid tanning devices or sun bathing.
  • Willing to forgo 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)
  • 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.
  • Willing to complete all study measurements and assessments in compliance with the protocol.

Exclusion Criteria:

  • Non-plaque or drug-induced psoriasis
  • Currently using corticosteroid or immunosuppressive therapy except for Class 5 or weaker topical corticosteroids to the face, groin, or scalp
  • Using any topical therapy except for the following:

    1. Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry
    2. Immunosuppressive therapies for 4 weeks prior to study entry
    3. Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry
    4. Biologic therapies for 3 months prior to study entry.
  • Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening.
  • Viral, fungal, or bacterial skin infection.
  • Pregnant or lactating woman.
  • Currently participating in another study with an investigational drug or within 28 days of study entry
  • 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
  • History or presence of any of the following:

    1. Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) at screening
    2. Renal disease and/or serum creatinine > 1.5xULN at screening
  • Has QTc(f) intervals of > 450 msec at the screening or pre-dose ECG
  • Subject is receiving any drugs known to prolong the QTc interval, including any anti-arrhythmic medications within 2 weeks prior to screening
  • Subject is receiving any drug that is a strong CYP enzyme inhibitor
  • Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme
  • 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): NCT02106195


Locations
United States, California
UC Irvine Health, Dept of Dermatology
Irvine, California, United States, 92697
Sponsors and Collaborators
Kadmon Corporation, LLC

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02106195     History of Changes
Other Study ID Numbers: KD025-205
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014

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