ETCABio - Evaluation of Skin Tests in Biotherapy Allergies
Key facts
- Where
- Angers, FranciaországSee the site
- Phase
- 4. fázis
Where in Franciaország
- Centre Hospitalier Universitaire D'AngersAngers, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire D'Angers
- Trial code
- EU 2024-519812-15-00
- Record updated
- 2026. március 19.
- Original description
The primary objective is to determine, in non-allergic patients treated with biotherapy, the maximum non-irritant concentration of the biotherapy that can be used in allergologic skin tests (prick tests and intradermal tests) for patients suspected of hypersensitivity to the said biotherapy.Read full original descriptionShow less
The primary objective is to determine, in non-allergic patients treated with biotherapy, the maximum non-irritant concentration of the biotherapy that can be used in allergologic skin tests (prick tests and intradermal tests) for patients suspected of hypersensitivity to the said biotherapy.
Inclusion: Age ≥ 18 years; Patient treated with one of the biotherapies under study (Atezolizumab, Nivolumab, Obinutuzumab, Durvalumab, Pembrolizumab, Daratumumab, Cemiplimab) 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: Pregnancy, breastfeeding* (For women of childbearing age, the absence of pregnancy will be confirmed by a blood pregnancy test (unless already conducted as part of the care or if pregnancy is ruled out); 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; 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.