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Evaluation of Skin Tests in Biotherapy Allergies

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Angers
NCT06971848 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway. These biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction). Unlike other treatments, such as antibio

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📋 Eligibility rules (as published)
Inclusion Criteria : * Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects. * Subjects covered by or having the rights to medical care assurance * Written informed consent obtained from subject * If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed). Exclusion Criteria: * Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests. * Poor understanding of the French language * Pregnancy, breastfeeding * Persons in detention by judicial or administrative decision * Person admitted to a health or social establishment for purposes other than research * Person subject to a legal protection measure
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What it tests

  • Drug skin tests (investigating hypersensitivity to a biotherapy)
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Where

1 site
CHU Angers
Angers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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