Recruitment

Recruitment Status
Completed

Inclusion Criteria

Willing to complete all study measurements and assessments in compliance with the protocol.
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 complete all study measurements and assessments in compliance with the protocol.
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.
Adequate bone marrow function
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 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.
Willing to avoid tanning devices or sun bathing.
Negative urine pregnancy test (for women of childbearing potential)

Exclusion Criteria

Pregnant or lactating woman.
Renal disease and/or serum creatinine > 1.5xULN at screening
Non-plaque or drug-induced psoriasis
...
Pregnant or lactating woman.
Renal disease and/or serum creatinine > 1.5xULN at screening
Non-plaque or drug-induced psoriasis
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
Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) at screening
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
Currently participating in another study with an investigational drug or within 28 days of study entry
Subject is receiving any drugs known to prolong the QTc interval, including any anti-arrhythmic medications within 2 weeks prior to screening
Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening.
Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme
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.
Immunosuppressive therapies for 4 weeks prior to study entry
Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry
Biologic therapies for 3 months prior to study entry.
Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry
Viral, fungal, or bacterial skin infection.

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

Description

This will be a Phase 2a, open-label, single-arm, safety and tolerability study of belumosudil given daily for treatment of psoriasis. Eight subjects with moderately severe psoriasis who have failed at least 1 line of systemic therapy will be enrolled. Treatment Period Eligible subjects who have fail...

This will be a Phase 2a, open-label, single-arm, safety and tolerability study of belumosudil given daily for treatment of psoriasis. Eight subjects with moderately severe psoriasis who have failed at least 1 line of systemic therapy will be enrolled. Treatment Period Eligible subjects who have failed at least 1 line of systemic therapy will be entered and treated for 4 weeks with 200 mg of belumosudil given orally once daily (QD). Subjects will undergo medical history evaluations, physical examinations, vital sign measurements, weight, adverse event assessments, concomitant medication assessments, and laboratory testing including but not limited to blood sample collection for hematology and chemistry, urinalysis, coagulation, lipid panel, electrocardiogram, pregnancy test for females of childbearing potential, testing with the Psoriasis Area and Severity Index (PASI) scale and Physician Global Assessment (PGA) scale, and pharmacokinetic sampling. Follow-up Period Follow-up visits will occur 30 days after the last dose of study drug in the Treatment Period of the study. This visit must be done within ± 3 days of the scheduled visit. The same assessments will be performed as in the Treatment Period. The duration of the study is 12 weeks: up to 4 weeks for screening, 4 weeks of treatment, and 4 weeks of follow-up.

Inclusion Criteria

Willing to complete all study measurements and assessments in compliance with the protocol.
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 complete all study measurements and assessments in compliance with the protocol.
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.
Adequate bone marrow function
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 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.
Willing to avoid tanning devices or sun bathing.
Negative urine pregnancy test (for women of childbearing potential)

Exclusion Criteria

Pregnant or lactating woman.
Renal disease and/or serum creatinine > 1.5xULN at screening
Non-plaque or drug-induced psoriasis
...
Pregnant or lactating woman.
Renal disease and/or serum creatinine > 1.5xULN at screening
Non-plaque or drug-induced psoriasis
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
Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) at screening
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
Currently participating in another study with an investigational drug or within 28 days of study entry
Subject is receiving any drugs known to prolong the QTc interval, including any anti-arrhythmic medications within 2 weeks prior to screening
Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening.
Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme
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.
Immunosuppressive therapies for 4 weeks prior to study entry
Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry
Biologic therapies for 3 months prior to study entry.
Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry
Viral, fungal, or bacterial skin infection.

Locations

Irvine, California, 92697
Irvine, California, 92697

Tracking Information

NCT #
NCT02106195
Collaborators
Not Provided
Investigators
Not Provided