A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002), given every 2 weeks for 7 doses, in adult subjects with moderate-to-severe AD inadequately controlled by topical treatments. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 7 doses of subcutaneous lirentelimab.

Timeline

Start

2022-06-27

Primary completion

2023-12-18

Completion

2024-04-17

Outcome

Missed primary endpoint

Stopped: “No longer pursuing development”

registry p = 0.4662; Risk Difference (RD) 5.1 (95% CI -9.8 to 19.8) NCT05155085 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	lirentelimab	Monoclonal antibody	300 mg	Subcutaneous

Indications