Phase 2
Completed N=38
Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy
Source: ClinicalTrials.gov NCT02317627 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population — 16.7; 8.3; 9.1; 11.4 Percentage of participants (%)
Summary
This study was performed to evaluate the safety, tolerability, activity, pharmacokinetics (PK), and daily dose regimen of KD025 administered orally (PO) for 12 weeks to subjects with psoriasis vulgaris who failed at least one line of systemic therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population |
16.7; 8.3; 9.1; 11.4; 41.7; 50.0 | — |
| PRIMARY Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population |
16.7; 14.3; 14.3; 15.4; 41.7; 71.4 | — |
| PRIMARY Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population |
12; 11; 8; 31; 69.2; 46.2 | — |
| SECONDARY Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--ITT Population |
12.4; 10.3; 14.4; 12.3; -8.8; -6.0 | 0.0282 sig |
| SECONDARY Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--Evaluable Population |
12.4; 7.6; 15.5; 12.0; -8.8; -7.9 | 0.0282 sig |
| SECONDARY Efficacy: Percentage of Subjects With a Decrease in PASI After 4 Weeks---ITT Population |
76.9; 66.7; 58.3; 67.6 | — |
| SECONDARY Efficacy: Percentage of Subjects With a Decrease in PASI Score After 8 Weeks---ITT Population |
83.3; 100; 85.7; 89.3 | — |
| SECONDARY Efficacy: Percentage of Subjects With a Decrease in PASI Score at EOT---ITT Population |
75.0; 75.0; 81.8; 77.1 | — |
| SECONDARY Efficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population |
75.0; 85.7; 71.4; 76.9; 83.3; 100 | — |
| SECONDARY Efficacy: Mean Change in PASI Score After 4 Weeks---ITT Population |
-4.7; -2.6; -2.3; -3.2 | 0.0064 sig |
| SECONDARY Efficacy: Mean Change in PASI Score After 8 Weeks---ITT Population |
-8.6; -6.4; -4.7; -6.9 | 0.0137 sig |
| SECONDARY Efficacy: Mean Change in PASI Score at 4 and 8 Weeks---Evaluable Population |
-4.4; -3.5; -2.7; -3.7; -8.6; -6.8 | 0.0140 sig |
| SECONDARY Efficacy: Percentage of Subjects With Improvement in PGA af 4 Weeks---ITT Population |
0; 0; 0; 0; 7.7; 8.3 | — |
| SECONDARY Efficacy: Percentage of Subjects With Improvement in PGA af 8 Weeks---ITT Population |
8.3; 0; 0; 3.6; 25.0; 11.1 | — |
| SECONDARY Efficacy: Percentage of Subjects With Improvement in PGA af EOT--ITT Population |
0; 0; 0; 0; 33.3; 25.0 | — |
| SECONDARY Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population |
0; 0; 0; 0; 8.3; 0 | — |
| SECONDARY Efficacy: Mean Changes in DLQI at EOT--ITT Population |
-4.9; -5.1; -2.5; -4.2 | 0.004 sig |
| SECONDARY Efficacy: Mean Changes in DLQI at 12 Weeks--Evaluable Population |
-4.9; -6.3; -2.3; -4.6 | 0.004 sig |
| SECONDARY Pharmacokinetics: Cmax of Parent Drug KD025, KD025m1, and KD025m2 |
3140; 1770; 23.2; 22.8; 632; 203 | — |
| SECONDARY Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 |
16200; 9150; 2300; 757; 18800; 21800 | — |
| SECONDARY Pharmacokinetics: t(1/2) of KD025 |
8.00; 5.13 | — |
| SECONDARY Pharmacokinetics: MR C(Max) and MR AUC(0-t) for KD025m1 and KD025m2 |
0.00736; 0.00984; 0.199; 0.101; 0.00458; 0.00577 | — |
Eligibility Criteria
Inclusion Criteria
- Able to provide written informed consent prior to the performance of any study specific procedures
- Diagnosis of moderately severe plaque psoriasis that has been moderately stable for 6 months and failed at least 1 line of systemic or phototherapy and is a candidate for additional systemic therapy
- PASI of ≥ 12 within the 24-hour period prior to the first dose of study drug
- At least 10% of body surface area 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: absolute neutrophil count > 1500/mm^3; hemoglobin > 9.0 g/dL; platelets > 100,000/mm^3
- Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- Agree to use a highly effective method of birth control ( 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:
- 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 interviewed regarding use of alcohol, have levels repeated and participation in the study should be discussed with the medical monitor.)
- Renal disease and/or serum creatinine > 1.5 × ULN at screening
- QTc(F) interval (QT interval data corrected using Fridericia's formula) > 450 msec at the screening or predose ECG
- Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor
Data sourced from ClinicalTrials.gov (NCT02317627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.