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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Formulation for intravenous infusion
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
...and 4 more locations
Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation
Time frame: Through study completion, approximately 30 weeks
Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs
Time frame: Through study completion, approximately 30 weeks
AK006 serum concentrations
Time frame: Through study completion, approximately 30 weeks
AK006 Anti-drug Antibodies (ADAs)
Number of participants with positive or negative AK006-ADAs.
Time frame: Through study completion, approximately 30 weeks
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