Phase 2
Completed N=8
A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris
Source: ClinicalTrials.gov NCT02106195 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Sep 2021
Primary outcomePrimary: Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability — 4; 1; 1; 0 Participants
Summary
The primary objective is to assess the safety and tolerability of 200 mg of belumosudil administered orally once daily for 28 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability |
4; 1; 1; 0; 0; 0 | — |
| SECONDARY Efficacy: Change in Overall PASI (Psoriasis Area and Severity Index) From Baseline to Week 4 and Week 8 |
17.5; 16.3; -1.1; 14.7; 0.0 | 0.324 |
| SECONDARY Efficacy: Physician Global Assessment (PGA) at Week 4 and Week 8 |
0; 1; 1; 4; 2; 0 | — |
| SECONDARY PK: Cmax and Cmin |
1240; 21.3; 221; 810; 15.0; 131 | — |
| SECONDARY PK: AUC(0-24) and AUC(Inf) |
7360; 1040; 5500; 162; 8230; 1120 | — |
| SECONDARY PK: Tmax |
2.00; 2.00; 2.00; 4.00; 4.00; 4.00 | — |
| SECONDARY PK: t(1/2) |
6.08; 4.25; 5.27; 2.26 | — |
Eligibility 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 ( 1.5 × the upper limit of normal (ULN) at screening
- 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.
Data sourced from ClinicalTrials.gov (NCT02106195). 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.