Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis

Phase 2 Completed 50 enrolled Aclaris Therapeutics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of participants with moderate or severe atopic dermatitis (AD).

Timeline

Start: 2020-09-30
Primary completion: 2021-04-08
Completion: 2021-04-22

Outcome

Met primary endpoint

registry analysis (superiority test); ATI-1777 vs Vehicle; p <0.001; Least Square Means (LSM) % Differences -33.01 NCT04598269 ↗

paper Reduction was significantly greater in the ATI-1777-treated group on day 28 than in vehicle-treated group PMID 38299059 ↗

release “ATI-1777 Achieved Statistically Significant Result in the Primary Efficacy Endpoint at Week 4” aclaristx.com ↗

Publications

Changelian P, Xu C, Mnich S, Hope H, Kostecki K, Hirsch J, Loh CY, Anderson D, Blinn J, Hockerman S, Dick E, Smith W, Monahan J, Raoof T, Forman S, Burt D, Barnes B, Gordon D, Walker N, Sudzina J, Tucker S, Jacobsen J. ATI-1777, a Topical Jak1/3 Inhibitor, May Benefit Atopic Dermatitis without Systemic Drug Exposure: Results from Preclinical Development and Phase 2a Randomized Control Study ATI-1777-AD-201. JID Innov. 2023 Nov 28;4(2):100251. doi: 10.1016/j.xjidi.2023.100251. eCollection 2024 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LEPZACITINIB	Small molecule	2 %	Topical