RecruitingACTRN12621001333808

Mepolizumab for treatment of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome - A pilot study

Efficacy of mepolizumab in management of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome relapses: a pilot study


Sponsor

St Vincent's Hospital, Sydney

Enrollment

8 participants

Start Date

Sep 29, 2022

Study Type

Interventional

Conditions

Summary

This is a multi site open label pilot study designed to assess feasibility of further studies looking at the utility of mepolizumab in the treatment of DRESS syndrome. This is an investigator initiated study, with study drug being provided by GlaxoSmithKline. DRESS syndrome is a potentially life threatening, idiosyncratic adverse drug reaction. It is typically accompanied by morbilliform rash, fever, lymphadenopathy, haematological abnormalities including eosinophilia and the presence of atypical lymphocytes, and multiple organ involvement. A number of drugs can cause DRESS syndrome and the common causes include antiepileptic drugs, allopurinol and sulfonamides. We aim to recruit 8 participants over 1.5 - 2 years across the study sites. Mepolizumab, a humanised monoclonal antibody that targets IL5, will be used in conjunction with standard therapy in participants with DRESS syndrome. Mepolizumab is currently approved for use in refractory eosinophilic asthma. Participants will be involved in the study for ~6 months. In addition to standard care investigations/monitoring, blood samples for cytokine analysis and lymphocyte profiling, and patient reported outcome measures will be collected at each visit.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) is a rare but potentially life-threatening reaction to certain medications — including some anti-epileptic drugs, allopurinol, and antibiotics. It causes a widespread rash, fever, swollen glands, and can seriously damage organs including the liver, kidneys, and lungs. Standard treatment is usually high-dose steroids, but not everyone responds well, and the condition can be prolonged and dangerous. This pilot study is testing whether mepolizumab — a medication that targets a protein called IL-5, which drives the eosinophil (a type of white blood cell) component of the reaction — can help when added to standard treatment. Mepolizumab is already approved for severe eosinophilic asthma, and the hope is that it may similarly calm the immune overreaction in DRESS. You may be eligible if you are 18 or older and have been diagnosed with DRESS syndrome based on standard clinical criteria, and your eosinophil count is elevated. Women who are pregnant or breastfeeding, children, and those with other eosinophilic conditions or active parasitic infections are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The mode of administration: 100mg mepolizumab powder reconstituted in the vial with 1.2 mL of sterile water for injection administered subcutaneously. The frequency of administration is once only at

The mode of administration: 100mg mepolizumab powder reconstituted in the vial with 1.2 mL of sterile water for injection administered subcutaneously. The frequency of administration is once only at Weeks 0, 4, 8 & 12 Administration of the study treatment mepolizumab, will be performed by clinical study site staff at study visits as listed above. Participants will be monitored for a total of 28 weeks post-treatment commencement and 8 weeks post completion of treatment. Participants will be monitored for a total of 28 weeks post-treatment commencement


Locations(6)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW,SA,VIC, Australia

Nepean Hospital - Kingswood

NSW,SA,VIC, Australia

The Alfred - Melbourne

NSW,SA,VIC, Australia

Campbelltown Hospital - Campbelltown

NSW,SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,SA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,SA,VIC, Australia

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ACTRN12621001333808