Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome HES
Led by GlaxoSmithKline · Updated on 2025-11-25
123
Participants Needed
91
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying depemokimab in adults with uncontrolled Hypereosinophilic Syndrome HES who are already receiving standard treatment. This phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter trial focuses on patients with a confirmed HES diagnosis, a history of at least two flares in the past year, and a high blood eosinophil count. The study aims to evaluate the frequency of HES flares over 52 weeks while maintaining participants on stable therapy. Participants will be randomly assigned in a 21 ratio to receive either depemokimab or a placebo, in addition to their existing standard of care treatment. The study lasts 52 weeks, during which participants continue their usual HES therapy alongside the study drug or placebo. The trial is designed to assess safety and efficacy with careful monitoring throughout. During the study, participants will undergo regular assessments including monitoring of HES flare frequency, time to first flare, and fatigue levels using the Brief Fatigue Inventory. Researchers will track clinical symptoms, blood eosinophil counts, and any adverse events. The total participation time is up to 52 weeks, with ongoing safety evaluations to understand the impact of depemokimab compared to placebo.
CONDITIONS
Brief Title
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who weigh at least 40 kilograms at Screening Visit 1.
- Participants with a documented diagnosis of Hypereosinophilic Syndrome before Visit 2.
- History of two or more HES flares within the 12 months before Visit 1.
- Female participants must not be pregnant or breastfeeding and either be of non-childbearing potential or use a highly effective contraceptive method with less than 1% failure rate.
- Capable of providing signed informed consent.
You will not qualify if you...
- Participants with HES symptoms that may pose unacceptable risks or affect study results as judged by the investigator.
- Participants with chronic or ongoing active infections needing systemic treatment or parasitic infestation within 6 months before Visit 1.
- Participants with known immunodeficiency except due to HES treatment.
- Participants with history or current lymphoma.
- Participants with current cancer or cancer remission less than 5 years, except resected localized skin carcinoma.
- Participants with blood cancers where HES is not the primary diagnosis.
- Participants with cirrhosis or unstable liver/biliary disease.
- Participants with severe uncontrolled cardiovascular disease.
- Participants diagnosed with vasculitis.
- Participants with hypereosinophilia without symptoms or organ dysfunction.
- Participants diagnosed with Eosinophilic granulomatosis with polyangiitis (EGPA).
- Participants allergic or intolerant to monoclonal antibodies or study product components.
- Participants with previous failure using anti-IL-5/5R therapy.
- Participants who received monoclonal antibodies within 30 days or 5 half-lives before Visit 1.
- Participants positive for the FIP1L1-PDGFRα fusion gene.
- Participants with prolonged QTcF interval at Screening Visit 1.
- Participants not responding to corticosteroid therapy as judged by the investigator.
- Pregnant or breastfeeding participants.
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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