Ongoing trials with biological drugs for EGIDs
| Monoclonal Antibody | Target | Clinicaltrials.gov ID | Design | Indication | Dose | Primary outcome |
|---|---|---|---|---|---|---|
| Mepolizumab | IL-5 | NCT03656380 | Placebo-controlled, phase 2 RCT | EoE | 300 mg s.c. monthly for 6 months or placebo | Mean change in dysphagia from baseline to 3 months post-treatment assessed by EEsAI |
| Benralizumab | IL5Rα | NCT03473977 | Placebo-controlled, phase 2/3 RCT | EGE | 30 mg s.c. every 4 weeks or placebo | At week 12 % of patients in histological remission (< 30 eos/HPF) |
| Dupilumab | IL-4Rα | NCT03678545 | Placebo-controlled, phase 2 RCT | EGE | 600 mg s.c. initial dose and 300 mg s.c. subsequent doses every two weeks for 6 injections | At week 12 relative change from baseline of the peak eosinophil counts in the 5 most eosinophil dense HPFs in the gastric antrum and/or body |
| Lirentelimab (AK002) | Siglec-8 | NCT04322708 | Placebo-controlled, phase 2/3 RCT | EoE | 1 mg/kg, 3 mg/kg or placebo monthly for 6 doses | At week 24 proportion of patients achieving esophageal intraepithelial eosinophil count of ≤ 6 eos/HPF and mean absolute change DSQ score from baseline to week 23–24 |
| Lirentelimab (AK002) | Siglec-8 | NCT04322604 | Placebo-controlled, phase 3 RCT | EGE | 1 mg/kg followed by 5 monthly doses of 3 mg/kg or placebo | At week 24 proportion of patients achieving eosinophil count ≤ 4 cells per HPF in 5 gastric HPF and/or eosinophil count ≤ 15 cells per HPF in 3 duodenal HPF; mean absolute change in 6 symptoms total symptom as measured by the PRO questionnaire |
Siglec-8: sialic acid-binding immunoglobulin-like lectin 8