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University Hospital, Angers launches Phase 1 clinical trial for biotherapy allergy skin testing; researchers aim to establish standardized concentration guidelines for 70 United States participants

May 19, 2025 Press Release 2 min read

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May 19, 2025 (press release) –

May 14 -- University Hospital , Angers has listed an interventional clinical trial, Phase 1, to study Skin Tests in Biotherapy Allergies. The trial's principal investigator is Martine MORISSET.

The trial for a sample of 70 participants from USA is not yet open for recruiting.

The study is being conducted for the following purpose:

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 stologic 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 antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.

The full document can be viewed at : https://clinicaltrials.gov/study/NCT06971848

[Category: Health Care Equipment, Health Care, Partnerships and Alliances, Clinical Trials, Clinical Study, Medical Science, Medicine Research , Biomedical Research , Behavioral Research , Experimentation]

Source: ClinicalTrials.gov

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