None listed
Conditions
Brief 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.
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 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 mon
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
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (18 years old and above) who are diagnosed with DRESS syndrome (based on the RegiSCAR criteria) and with eosinophil count >0.8 x 10^9/L.
Exclusion criteria
those with other eosinophilic disorders or concurrent parasitic infection, pregnant or breastfeeding patients, children and those who are unable to give informed consent.
Outcome results
None listed