A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis

Autor:	Catherine Maari, Sara McCutchan, Athanasios Tsianakas, Nihar Bhakta, Scott Baumgartner, James Mackay, Robert Bissonnette, DeAnne Reid
Jazyk:	angličtina
Rok vydání:	2021
Předmět:	Moderate to severe medicine.medical_specialty Palmoplantar pustulosis CXCR2 business.industry Neutrophils Subgroup analysis Dermatology Pustules Placebo Double blind RIST4721 Internal medicine medicine Oral and maxillofacial surgery Trial registration business Neutrophil recruitment Original Research
Zdroj:	Dermatology and Therapy
ISSN:	2190-9172 2193-8210
Popis:	Introduction Palmoplantar pustulosis (PPP) is a chronic inflammatory skin condition with neutrophilic infiltration of the epidermis. RIST4721 antagonizes CXC chemokine receptor type 2, which is important in neutrophil recruitment and migration. In this study, the efficacy and safety of RIST4721 versus placebo were assessed in adult subjects with moderate to severe PPP. Methods This phase 2a, multicenter, randomized, double-blind, placebo-controlled study investigated RIST4721 versus placebo in subjects with moderate to severe PPP. Key eligibility criteria included: Palmoplantar Pustulosis Area and Severity Index (PPPASI) ≥ 8 and Palmoplantar Pustulosis Physician Global Assessment ≥ 3. Subjects were randomized 1:1 to RIST4721 300 mg or placebo once daily for 28 days. The primary efficacy endpoints were relative change from baseline in fresh and total pustule count at day 28. Results Fifteen subjects received RIST4721 and 19 subjects received placebo. Treatment with RIST4721 was found to be generally well tolerated. At day 28, the mean ± standard deviation (SD) relative change from baseline in fresh pustule count was 0.86 ± 0.692 and 0.53 ± 0.561 (P = 0.240) and in total pustule count was 0.99 ± 0.667 and 0.96 ± 0.672 (P = 0.804) for RIST4721 and placebo groups, respectively. Subgroup analysis of subjects with progressing disease demonstrated that subjects with a PPPASI-50 at day 28 was significantly higher for subjects treated with RIST4721 (71%) than placebo (15%) (P = 0.022). Conclusion Preliminary data suggest RIST4721 is well tolerated and may be a potential therapy for patients with PPP. Trial Registration RIST4721-201 was registered in June 2019 at clinicaltrials.gov: NCT03988335. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00632-7.
Databáze:	OpenAIRE
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