NCT05528861

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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	Lirentelimab (AK002)	Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-10-26
• Primary completion: 2023-12-27
• Completion: 2024-04-18
• First posted: 2022-09-06
• Last updated: 2024-09-27
• Results posted: 2024-09-27

Locations

67 sites across 3 countries: United States, Germany, Poland

Regulatory

• FDA-regulated drug study