Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: Phase 3, randomized, vehicle-controlled study (CAPTAIN-AD) - 05/04/22
, Miyoung Park, PhD g, ⁎ Abstract |
Background |
Asivatrep is a potent and selective antagonist of transient receptor potential vanilloid subfamily V member 1 (TRPV1), which plays an important role in itch and inflammation in atopic dermatitis (AD).
Objective |
This current study aimed to evaluate the efficacy and safety of asivatrep cream in patients with AD.
Methods |
For this phase 3 double-blind, vehicle-controlled study, patients aged ≥12 years with mild to moderate AD were enrolled and randomly assigned 2:1 to the 1.0% asivatrep or vehicle group for 8 weeks of twice-daily application (n = 240). The primary end point was the proportion of patients with an Investigator’s Global Assessment score (IGA) of 0 or 1 at week 8. Standard safety assessments were conducted.
Results |
At week 8, significantly more patients in the asivatrep group (36.0%) than in the vehicle group (12.8%) had IGA scores of 0 or 1 (P < .001); significantly more had ≥2 points of improvement on the IGA from baseline score (20.3% vs 7.7%; P = .01). The mean percentage reduction in the Eczema Area and Severity Index (EASI) score was 44.3% for the asivatrep group and 21.4% for the vehicle group at week 8 (P < .001). Significantly more asivatrep-treated patients experienced an improvement of at least 50%, 75%, and 90% on the EASI than the vehicle group. The mean ± SD change in the pruritus visual analog scale score at week 8 was −2.3 ± 2.4 for the asivatrep group and −1.5 ± 2.4 for the vehicle group (P = .02). No significant safety issues were reported.
Conclusion |
Asivatrep improved clinical signs and symptoms of AD and was well tolerated.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Key words : Atopic dermatitis, asivatrep, transient receptor potential vanilloid subfamily member 1 (TRPV1), pruritus
Abbreviations used : AD, EASI, EASI-50, EASI-75, EASI-90, IGA, TCI, TCS, TEAE, TRPV1, VAS
Plan
| This study was funded by AMOREPACIFIC R&D Center. The funders contributed to the conception and design of the study; the collection, analysis, and interpretation of the data; the drafting and critical revision of the report; and provided approval for submission. |
|
| Disclosure of potential conflict of interest: B. J. Kim has served as consultant and investigator for AMOREPACIFIC. Y. W. Lee has been investigator or consultant of AMOREPACIFIC, Galderma, Lilly, SCM Lifescience Co Ltd, and Therabest Co Ltd. C. Won has been an investigator for AstraZeneca, Celltrion, Dermira, Medipl, and Kangstem Biotech. D. H. Lee has been a consultant, investigator, and/or advisory board member for AbbVie, AMOREPACIFIC, Cutisbio, EHL Bio, HaplnScience, Kangstem Biotech, Novartis, Sanofi, and SCM Lifescience. K. Jung, H.-J. Nam, G. Choi, Y.-H. Park, and M. Park are employees of AMOREPACIFIC. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 149 - N° 4
P. 1340 - avril 2022 Retour au numéro
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