Clinical trial NCT06577116: Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Allakos Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation
timeFrame: Through study completion, approximately 30 weeks
measure: Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs
timeFrame: Through study completion, approximately 30 weeks
Secondary outcomes:
measure: AK006 serum concentrations
timeFrame: Through study completion, approximately 30 weeks
measure: AK006 Anti-drug Antibodies (ADAs)
timeFrame: Through study completion, approximately 30 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 601-004
state: Alabama
city: Bakersfield
country: United States
facility: Site 601-014
state: California
city: Upland
country: United States
facility: Site 601-015
state: California
city: Overland Park
country: United States
facility: Site 601-006
state: Kansas
city: Lexington
country: United States
facility: Site 601-019
state: Kentucky
city: Saint Louis
country: United States
facility: Site 601-011
state: Missouri
city: Cincinnati
country: United States
facility: Site 601-002
state: Ohio
city: El Paso
country: United States
facility: Site 601-010
state: Texas
city: Greenfield
country: United States
facility: Site 601-013
state: Wisconsin
city: Calgary
country: Canada
facility: Site 601-106
state: Alberta
city: Niagara Falls
country: Canada
facility: Site 601-107
state: Ontario
city: Toronto
country: Canada
facility: Site 601-108
state: Ontario
city: Québec
country: Canada
facility: Site 601-102
state: Quebec
city: Québec
country: Canada
facility: Site 601-105
state: Quebec
Study officials:
References: