A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis.
CXCR2
Neutrophils
Palmoplantar pustulosis
Pustules
RIST4721
Journal
Dermatology and therapy
ISSN: 2193-8210
Titre abrégé: Dermatol Ther (Heidelb)
Pays: Switzerland
ID NLM: 101590450
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
received:
26
08
2021
accepted:
06
10
2021
pubmed:
31
10
2021
medline:
31
10
2021
entrez:
30
10
2021
Statut:
ppublish
Résumé
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. 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. 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). Preliminary data suggest RIST4721 is well tolerated and may be a potential therapy for patients with PPP. RIST4721-201 was registered in June 2019 at clinicaltrials.gov: NCT03988335.
Identifiants
pubmed: 34716902
doi: 10.1007/s13555-021-00632-7
pii: 10.1007/s13555-021-00632-7
pmc: PMC8611156
doi:
Banques de données
ClinicalTrials.gov
['NCT03988335']
Types de publication
Journal Article
Langues
eng
Pagination
2179-2193Informations de copyright
© 2021. The Author(s).
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