A Phase 2 Multicenter Open-Label Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients with Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
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- STATUS
- Enrolling By Invitation
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- participants needed
- 6
Summary
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody to the inhibitory receptor Siglec-8, present on mast cells, eosinophils, and basophils. Binding of AK002 to Siglec-8 induces a signal that inhibits mast cell activation and can lead to apoptosis in eosinophils. In the presence of effector cells (such as natural killer [NK] cells), AK002 binding to Siglec-8 depletes circulating eosinophils by ADCC and may reduce eosinophil and mast cell numbers in tissue. This profile of activity may provide clinical benefit in diseases in which these cell types play a role, such as EG and/or EGE.
Details
| Condition | Gastroenteritis |
|---|---|
| Age | 99years or below |
| Clinical Study Identifier | 03664960 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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