Trials / Not Yet Recruiting

Not Yet RecruitingNCT06971848

Evaluation of Skin Tests in Biotherapy Allergies

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 70 (estimated)

Sponsor: University Hospital, Angers · Other Government
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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 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.

Conditions

Interventions

Type	Name	Description
OTHER	Drug skin tests (investigating hypersensitivity to a biotherapy)	allergologic skin tests (prick tests and intradermal tests)

Timeline

Start date: 2026-05-01
Primary completion: 2028-05-01
Completion: 2028-06-01
First posted: 2025-05-14
Last updated: 2026-03-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06971848. Inclusion in this directory is not an endorsement.