NCT03436797

A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria

An Open-Label, Pilot Study to Assess the Efficacy and Safety of AK002 (Siglec-8) in Subjects With Antihistamine-Resistant Chronic Urticaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, open-label study to assess the effects of AK002

Detailed description

This open-label study is to assess the effects of AK002, given as monthly intravenous infusions at up to 3 mg/kg. A total of 47 patients will be enrolled across 2-4 sites. All patients enrolled in the study will receive 6 monthly infusions of AK002 and will then be followed for another 8 weeks. Some patients will have the option to receive an additional 12 months of extended dosing.

Conditions

• Chronic Urticaria

Interventions

Type	Name	Description
DRUG	AK002	AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).

Timeline

• Start date: 2018-01-23
• Primary completion: 2018-11-21
• Completion: 2020-04-06
• First posted: 2018-02-19
• Last updated: 2024-03-04
• Results posted: 2024-01-23

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study