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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 720mg of AK006 IV | Experimental | Subjects in this arm will receive 4 doses of 720mg of AK006 via intravenous infusion every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK006 IV | Drug | Formulation for intravenous infusion |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AK006 serum concentrations | Through study completion, approximately 30 weeks | |
| AK006 Anti-drug Antibodies (ADAs) | Number of participants with positive or negative AK006-ADAs. | Through study completion, approximately 30 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 601-004 | Birmingham | Alabama | 35209 | United States | ||
| Site 601-014 |
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| Bakersfield |
| California |
| 93301 |
| United States |
| Site 601-015 | Upland | California | 91786 | United States |
| Site 601-006 | Overland Park | Kansas | 66211 | United States |
| Site 601-019 | Lexington | Kentucky | 40509 | United States |
| Site 601-011 | St Louis | Missouri | 63141 | United States |
| Site 601-002 | Cincinnati | Ohio | 45236 | United States |
| Site 601-010 | El Paso | Texas | 79912 | United States |
| Site 601-013 | Greenfield | Wisconsin | 53228 | United States |
| Site 601-106 | Calgary | Alberta | T2M 1A6 | Canada |
| Site 601-107 | Niagara Falls | Ontario | L2H 1H5 | Canada |
| Site 601-108 | Toronto | Ontario | M5G 1E2 | Canada |
| Site 601-102 | Québec | Quebec | G1V 4W2 | Canada |
| Site 601-105 | Québec | Quebec | G1W 4R4 | Canada |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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