A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. 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 6 doses of subcutaneous lirentelimab.

Timeline

Start

2022-10-26

Primary completion

2023-12-27

Completion

2024-04-18

Outcome

Missed primary endpoint

Stopped: “No longer pursuing development”

registry p = 0.8174; LSM Difference from Placebo 0.5 (95% CI -3.6 to 4.5) NCT05528861 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	lirentelimab	Monoclonal antibody	—	Subcutaneous

Indications