Delgocitinib Cream Shows Favorable Safety Profile in DELTA 2 Trial for Chronic Hand Eczema
核心洞察
The DELTA 2 trial evaluated the safety and systemic absorption of delgocitinib cream in adults with moderate to severe chronic hand eczema (搜索) (CHE).
Results showed minimal systemic absorption of delgocitinib with mean plasma concentrations remaining low throughout the 16-week study.
The treatment demonstrated a favorable safety profile, with adverse events comparable to the vehicle group and no clinically significant changes in lab parameters.
A Phase 3 clinical trial, DELTA 2, has demonstrated that delgocitinib cream 20 mg/g exhibits minimal systemic absorption and a favorable safety profile in adults with moderate to severe chronic hand eczema (搜索) (CHE). The study, a randomized, double-blind, vehicle-controlled trial, provides evidence supporting the topical application of delgocitinib as a safe and effective treatment option for CHE.
DELTA 2 Trial Design and Methodology
The DELTA 2 trial (NCT04872101) enrolled adults aged 18 to 84 with moderate to severe CHE, randomizing them in a 2:1 ratio to receive either delgocitinib cream (20 mg/g) or a cream vehicle. Participants applied the treatment twice daily for 16 weeks. The primary focus was on assessing systemic exposure through pharmacokinetic analysis, with blood samples collected at weeks 1, 4, and 16 to measure delgocitinib plasma concentrations.
Minimal Systemic Absorption
The study results indicated minimal systemic absorption of delgocitinib. The mean geometric plasma concentration of delgocitinib was 0.21 ng/mL at week 1, 0.20 ng/mL at week 4, and 0.17 ng/mL at week 16. The highest observed peak systemic exposure was 7.2 ng/mL. This contrasts with a phase 1 study where an oral dose of delgocitinib (1.5 mg) resulted in a mean concentration of 99.3 ng/mL.
Favorable Safety and Tolerability
Adverse events (AEs) were reported in 45.7% of patients in the delgocitinib group and 44.7% in the vehicle group. The most common AE was COVID-19 infection, reported in 11.7% of the delgocitinib group and 5.3% of the vehicle group. Only one serious adverse event occurred in the delgocitinib group (1.1%), deemed unrelated to treatment. No cases of malignancy, major cardiovascular events, or venous thromboembolic events were reported.
Laboratory Findings
Laboratory findings showed no clinically meaningful differences between the delgocitinib and vehicle groups across various markers, including hemoglobin, lymphocyte and neutrophil counts, platelet levels, alanine aminotransferase, LDL cholesterol, and triglycerides. Minor fluctuations remained within normal ranges, with no signs of liver toxicity or impact on lipid metabolism.
Implications for Chronic Hand Eczema Treatment
The DELTA 2 trial suggests that topical delgocitinib offers a safe approach for managing moderate to severe CHE, with minimal systemic exposure and a favorable safety profile. These findings support its potential as a valuable treatment option for patients suffering from this condition.