drugset / Trial / NCT06577116

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

NCT06577116 ↗

Phase 1 Completed 29 enrolled Allakos Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-08-28
Primary completion
2025-05-21
Completion
2025-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject AK006 Unknown 720 mg Intravenous