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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
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Site 601-004
Birmingham, Alabama, United States
Site 601-014
Bakersfield, California, United States
Site 601-015
Upland, California, United States
Site 601-006
Overland Park, Kansas, United States
Site 601-019
Lexington, Kentucky, United States
Site 601-011
St Louis, Missouri, United States
Site 601-002
Cincinnati, Ohio, United States
Site 601-010
El Paso, Texas, United States
Site 601-013
Greenfield, Wisconsin, United States
Site 601-106
Calgary, Alberta, Canada
Start Date
August 28, 2024
Primary Completion Date
May 21, 2025
Completion Date
May 21, 2025
Last Updated
August 27, 2025
29
ACTUAL participants
AK006 IV
DRUG
Lead Sponsor
Allakos Inc.
NCT06931405
NCT06873516
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07230418