NCT06577116

Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001

An Open-Label Extension Study Evaluating the Safety, Tolerability, PK, Immunogenicity, and Clinical Response of Multiple Doses of IV AK006 in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	AK006 IV	Formulation for intravenous infusion

Timeline

• Start date: 2024-08-28
• Primary completion: 2025-05-21
• Completion: 2025-05-21
• First posted: 2024-08-29
• Last updated: 2025-08-27

Locations

14 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study