Chronic Spontaneous Urticaria
Conditions
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.
Interventions
DRUGAK006 IV
Formulation for intravenous infusion
Sponsors
Allakos Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation | Through study completion, approximately 30 weeks |
| Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs | Through study completion, approximately 30 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AK006 serum concentrations | Through study completion, approximately 30 weeks | — |
| AK006 Anti-drug Antibodies (ADAs) | Through study completion, approximately 30 weeks | Number of participants with positive or negative AK006-ADAs. |
Countries
Canada, United States
Outcome results
None listed