A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).

Timeline

Start

2018-07-18

Primary completion

2019-06-24

Completion

2019-06-24

Outcome

Met primary endpoint

registry analysis (superiority test); Combined AK002 vs Placebo; p <0.001; LSM Difference from Placebo -98 (95% CI -121 to -76); ANCOVA NCT03496571 ↗

Publications

• Fu J, Sia T, Solecki R, Mallik S, Khuda R, Headen M, Bacchus L, Zheng M, Telukunta T, Shami S, Liu S, Sureshbabu S, Love K, Roby A, McDonald P, Jiang Y, Narayanan DH, Cunningham E, Matmatte AS, Tan PE, Leung J. Clinical and histologic remission achieved with upadacitinib in a patient with refractory eosinophilic gastritis and duodenitis. J Allergy Clin Immunol Pract. 2024 Jun;12(6):1649-1651. doi: 10.1016/j.jaip.2024.02.031. Epub 2024 Feb 27. No abstract available.
• Dellon ES, Gonsalves N, Rothenberg ME, Hirano I, Chehade M, Peterson KA, Falk GW, Murray JA, Gehman LT, Chang AT, Singh B, Rasmussen HS, Genta RM. Determination of Biopsy Yield That Optimally Detects Eosinophilic Gastritis and/or Duodenitis in a Randomized Trial of Lirentelimab. Clin Gastroenterol Hepatol. 2022 Mar;20(3):535-545.e15. doi: 10.1016/j.cgh.2021.05.053. Epub 2021 Jun 2.
• Dellon ES, Peterson KA, Murray JA, Falk GW, Gonsalves N, Chehade M, Genta RM, Leung J, Khoury P, Klion AD, Hazan S, Vaezi M, Bledsoe AC, Durrani SR, Wang C, Shaw C, Chang AT, Singh B, Kamboj AP, Rasmussen HS, Rothenberg ME, Hirano I. Anti-Siglec-8 Antibody for Eosinophilic Gastritis and Duodenitis. N Engl J Med. 2020 Oct 22;383(17):1624-1634. doi: 10.1056/NEJMoa2012047.

Drugs

Indications