Evaluation of Skin Tests in Biotherapy Allergies

Обзор

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.

Вмешательства

• Другое Drug skin tests (investigating hypersensitivity to a biotherapy)
  allergologic skin tests (prick tests and intradermal tests)

Первичные конечные точки

• maximum usable concentration considered non-irritant [Срок оценки: Day 1]

Вторичные конечные точки (2)

• possible occurrence of a delayed reaction at 48 hours post-testing [Срок оценки: Day 2]
• possible occurrence of a delayed reaction at one week post-testing [Срок оценки: Day 7]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU Angers — Angers

Идентификаторы

NCT: NCT06971848 · 49RC24_0373

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗