Phase 2
Completed N=110
A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT02852967 ↗Enrolled (actual)
110
Serious AEs
3.0%
Results posted
Sep 2021
Primary outcomePrimary: Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed — 8.7; 9.1; 19.0; 7.7 Percentage of participants — p=0.6384
Summary
This is a phase 2, randomized, placebo-controlled, 2-period study to evaluate the safety, tolerability, and efficacy of belumosudil in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed |
8.7; 9.1; 19.0; 7.7; 16.7; 10.9 | 0.6384 |
| SECONDARY Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed |
18.93; 20.60; 18.82; 19.80; 20.72; 19.55 | — |
| SECONDARY Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed |
-27.17; -19.61; -24.31; -20.07; -18.23; -22.78 | — |
| SECONDARY Efficacy: Number of Subjects With Clear or Almost Clear PGA at Week 16--LOCF |
1; 0; 2; 1; 2; 4 | — |
| SECONDARY Efficacy: Percentage of Subjects With Clear or Almost Clear PGA Comparing Belumosudil to Placebo at Week 16--LOCF |
-6.8; -11.1; -1.6; -7.3; -6.8 | 0.5728 |
| SECONDARY Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48 |
10.6; 16.5; 12.2; 11.0; 10.3; 12.5 | — |
| SECONDARY Efficacy: Percentage Change of Mean DLQI Score From Baseline to Week 16 and Week 48 |
-5.73; -14.8; -22.22; -6.4; -40.30; -12.55 | — |
| SECONDARY Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study |
14; 13; 14; 16; 11; 57 | — |
Eligibility Criteria
Inclusion Criteria
- Adult subjects between the ages of 18 and 65 years
- Able to provide written Informed Consent Form prior to the performance of any study-specific procedures
- Diagnosis of moderate to severe chronic plaque psoriasis and a candidate for systemic therapy or phototherapy
- PASI of ≥ 12 at screening and prior to the first dose of study drug, confirmed at Week 1 Day 1 (Baseline)
- ≥ 10% PASI body surface area involvement at screening and prior to the first dose of study drug, confirmed at Baseline
- Willing to avoid tanning devices
- Adequate bone marrow function:
- Absolute neutrophil count > 1500/mm^3
- Hemoglobin > 9.0 g/dL
- Platelets > 100,000/mm^3
- Adequate safety laboratory values:
- Serum total bilirubin within normal limits (WNL)
- Aspartate aminotransferase (AST) and alalnine aminotransferase (ALT) 14 drinks per week in a man or > 7 drinks per week in a woman. Approximately 10 g of alcohol equaled one "drink" unit. One unit equaled 1 ounce of distilled spirits, one 12-ounce beer, or one 4-ounce glass of wine
- QT interval data corrected using Fridericia's formula (QTcF) > 450 msec (average of 3 readings) during screening
- Exposure to belumosudil or known allergy/sensitivity to belumosudil within the last 6 months prior to study entry or any other ROCK-2 inhibitor
- History or presence of any of the following:
- ALT or AST > 2.0 × ULN at screening
- Renal disease and/or serum creatinine > 1.5 × ULN at screening
Data sourced from ClinicalTrials.gov (NCT02852967). 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.