Table 2.
Ongoing clinical trials in patients with primary eosinophilia.
| Drug (NCT number) | Title | Start date–estimated completion date | Estimated enrollment (age at inclusion) |
Phase (Design) |
Comparator | Primary outcome (route of administration) | Locations (number of sites) |
|---|---|---|---|---|---|---|---|
| Benralizumab (anti-IL-5r mAb) (NCT04191304) |
A phase 3 study to evaluate the efficacy and safety of benralizumab in patients with hypereosinophilic syndrome (HES) (NATRON) | 22 July 2020–4 November 2024 | 120 participants (≥12 years) |
Phase 3 (Double-Blind) |
Placebo | Time to first HES worsening/flares (SC) |
United States, Austria, Belgium, Denmark, France, Germany, Israel, Italy, Japan, the Netherlands, Poland, Switzerland (46) |
| Depemokimab (anti-IL-5 mAb) (NCT05334368) |
Depemokimab in participants with hypereosinophilic syndrome, efficacy, and safety trial (DESTINY) | 6 September 2022–30 May 2025 | 120 participants (≥18 years) |
Phase 3 (Double-blind) |
Placebo | Frequency of HES flares (SC) |
United States, China, Japan, Republic of Korea, Spain (12) |
| Imatinib (TKI) Ruxolitinib (JAK inhibitor) (NCT00044304) |
Tyrosine kinase inhibition to treat myeloid hypereosinophilic syndrome | 26 September 2002–1 January 2026 | 60 participants (>2 years of age for imatinib, and ≥18 years of age for ruxolitinib) |
Phase 2 (Open-label) |
None | Peripheral blood absolute eosinophil count (oral) |
United States (1). |
| Ruxolitinib (JAK inhibitor) (NCT03801434) |
Ruxolitinib in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders | 15 November 2019–21 October 2023 | 25 participants (≥18 years) |
Phase 2 (Open-label) |
None | Overall response rate (oral) | United States (4) |
| Mepolizumab (anti-IL-5 mAb) (NCT04965636) |
Study in pediatrics with hypereosinophilic syndrome (SPHERE) | 14 July 2022–13 September 2023 | 25 participants (6–17 years) |
Phase 3 (Open-label) |
None | Number of HES flares experienced by participants per year (SC) |
United States, Argentina, Spain (9) |
| Benralizumab (anti-IL-5r mAb) (NCT02130882) |
Study to evaluate safety and efficacy of benralizumab in subjects with hypereosinophilic syndrome (HESIL5R) | 19 May 2014–31 December 2023 | 20 participants (≥18–75 years) |
Phase 2 + 3 (Double-blind) |
Placebo | Number of participants with a 50% reduction in peripheral blood eosinophilia at week 12 (SC) |
United States (1) |
anti-IL-5, anti-interleukin 5; anti-IL-5r, anti-interleukin 5 receptor; HES, hypereosinophilic syndrome; JAK, Janus kinase; mAB, monoclonal antibody; SC, subcutaneous injection; TKI, tyrosine kinase inhibitor. Database search of clin.trial.gov March 2023.