NCT05155085

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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Lirentelimab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 80 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), 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.

Conditions

• Atopic Dermatitis

Interventions

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

Timeline

• Start date: 2022-06-27
• Primary completion: 2023-12-18
• Completion: 2024-04-17
• First posted: 2021-12-13
• Last updated: 2024-10-15
• Results posted: 2024-09-24

Locations

55 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study