Status:
COMPLETED
Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
Lead Sponsor:
Allakos Inc.
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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. Qu...
Eligibility Criteria
Inclusion
- Key
- Enrolled in Part C of Study AK006-001 (NCT06072157) and completed the randomized, double-blind, placebo-controlled treatment period and the Day 99 Visit.
- Acceptable demonstration of tolerance to study drug during the AK006-001 study as determined by the investigator.
- Acceptable demonstration of protocol compliance during the AK006-001 study as determined by the investigator.
- Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use a highly effective method of contraception with \<1% failure rate or abstain from sexual activity from Screening until the end of the study, or for 16 weeks following the last dose of AK006, whichever is longer.
- Key
Exclusion
- Pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Planned use of an approved or investigational therapy to treat CSU other than a single 2nd- or later-generation H1-AH between 1× and 4× the licensed dose and frequency, during the study.
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06577116
Start Date
August 28 2024
End Date
May 21 2025
Last Update
August 27 2025
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 601-004
Birmingham, Alabama, United States, 35209
2
Site 601-014
Bakersfield, California, United States, 93301
3
Site 601-015
Upland, California, United States, 91786
4
Site 601-006
Overland Park, Kansas, United States, 66211