A Safety and Tolerability Study of KD025 Treatment in Subjects With Moderately Severe Psoriasis Vulgaris - Full Text View

Purpose

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

Condition	Intervention	Phase
Psoriasis Vulgaris	Drug: KD025	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:

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:

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:

Improvement in Physicians Global Assessment (PGA) [ Time Frame: 8 weeks ]
To achieve improvement in PGA
Change In Cytokine Expression [ Time Frame: 28 days ]
Change in cytokine expression in punch biopsy after 28 days of treatment with KD025


Enrollment:	8
Study Start Date:	April 2014
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: KD025 KD025 200 mg (two 100 mg capsules) orally once daily for 28 days	Drug: KD025 Other Name: SLX-2119

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106195

Locations


United States, California
UC Irvine Health, Dept of Dermatology
Irvine, California, United States, 92697

Sponsors and Collaborators

Kadmon Corporation, LLC

More Information


Responsible Party:	Kadmon Corporation, LLC
ClinicalTrials.gov Identifier:	NCT02106195 History of Changes
Other Study ID Numbers:	KD025-205
Study First Received:	April 2, 2014
Last Updated:	October 9, 2014

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases

ClinicalTrials.gov processed this record on July 17, 2017