Recruitment

Recruitment Status
Completed

Inclusion Criterias

Adequate bone marrow function
Negative urine pregnancy test (for women of childbearing potential)
Willing to avoid tanning devices or sun bathing.
...
Adequate bone marrow function
Negative urine pregnancy test (for women of childbearing potential)
Willing to avoid tanning devices or sun bathing.
Willing to complete all study measurements and assessments in compliance with the protocol.
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.
Had a PASI of ≥12
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.
Willing to forgo systemic and topical treatments for psoriasis during the course of the study.
At least 10% of body surface area that is affected by plaque psoriasis.

Exclusion Criterias

Subject is receiving any drug that is a strong CYP enzyme inhibitor
Has QTc(f) intervals of > 450 msec at the screening or pre-dose ECG
Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry
...
Subject is receiving any drug that is a strong CYP enzyme inhibitor
Has QTc(f) intervals of > 450 msec at the screening or pre-dose ECG
Methotrexate, acitretin, or cyclosporine for 4 weeks prior to 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
Pregnant or lactating woman.
Subject is receiving any drugs known to prolong the QTc interval, including any anti-arrhythmic medications within 2 weeks prior to screening
Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) at screening
Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry
Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme
Biologic therapies for 3 months prior to study entry.
Viral, fungal, or bacterial skin infection.
Currently participating in another study with an investigational drug or within 28 days of study entry
Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening.
Currently using corticosteroid or immunosuppressive therapy except for Class 5 or weaker topical corticosteroids to the face, groin, or scalp
Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor.
Renal disease and/or serum creatinine > 1.5xULN at screening
Non-plaque or drug-induced psoriasis
Immunosuppressive therapies for 4 weeks prior to study entry

Summary

Conditions
Psoriasis Vulgaris
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criterias

Adequate bone marrow function
Negative urine pregnancy test (for women of childbearing potential)
Willing to avoid tanning devices or sun bathing.
...
Adequate bone marrow function
Negative urine pregnancy test (for women of childbearing potential)
Willing to avoid tanning devices or sun bathing.
Willing to complete all study measurements and assessments in compliance with the protocol.
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.
Had a PASI of ≥12
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.
Willing to forgo systemic and topical treatments for psoriasis during the course of the study.
At least 10% of body surface area that is affected by plaque psoriasis.

Exclusion Criterias

Subject is receiving any drug that is a strong CYP enzyme inhibitor
Has QTc(f) intervals of > 450 msec at the screening or pre-dose ECG
Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry
...
Subject is receiving any drug that is a strong CYP enzyme inhibitor
Has QTc(f) intervals of > 450 msec at the screening or pre-dose ECG
Methotrexate, acitretin, or cyclosporine for 4 weeks prior to 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
Pregnant or lactating woman.
Subject is receiving any drugs known to prolong the QTc interval, including any anti-arrhythmic medications within 2 weeks prior to screening
Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) at screening
Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry
Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme
Biologic therapies for 3 months prior to study entry.
Viral, fungal, or bacterial skin infection.
Currently participating in another study with an investigational drug or within 28 days of study entry
Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening.
Currently using corticosteroid or immunosuppressive therapy except for Class 5 or weaker topical corticosteroids to the face, groin, or scalp
Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor.
Renal disease and/or serum creatinine > 1.5xULN at screening
Non-plaque or drug-induced psoriasis
Immunosuppressive therapies for 4 weeks prior to study entry

Locations

Irvine, California, 92697
Irvine, California, 92697

Tracking Information

NCT #
NCT02106195
Collaborators
Not Provided
Investigators
Not Provided