Evaluation of Skin Tests in Biotherapy Allergies
Launched by UNIVERSITY HOSPITAL, ANGERS · May 6, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Evaluation of Skin Tests in Biotherapy Allergies," is studying how to better identify allergic reactions in patients receiving certain biotherapy treatments. Biotherapies are special medications made from living organisms and are commonly used to treat serious conditions like cancer and blood disorders. While these treatments can be very effective, they can also cause allergic reactions, which can be confusing because they don’t always present clear symptoms. The goal of this trial is to find the right way to test for these allergies, so doctors can better manage any side effects.
To be part of this study, participants need to be between the ages of 65 and 74 and must have already received at least two doses of one of the biotherapies being tested, like Atezolizumab or Pembrolizumab, without any signs of an allergic reaction. They should also be able to understand instructions in French and must not be pregnant or breastfeeding. Participants will undergo skin tests to help researchers determine the best practices for identifying these allergies. This research is important because it aims to improve patient safety and care for those receiving biotherapy treatments.
Gender
ALL
Eligibility criteria
- 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
About University Hospital, Angers
The University Hospital of Angers is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its multidisciplinary expertise and state-of-the-art facilities to investigate new therapeutic approaches and improve patient outcomes. Committed to excellence in patient care and medical education, the University Hospital of Angers collaborates with a network of researchers and healthcare professionals to facilitate groundbreaking studies across various medical fields, ensuring rigorous adherence to ethical standards and regulatory compliance. Through its clinical trial initiatives, the institution aims to contribute significantly to the advancement of medical knowledge and the development of effective treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Angers, , France
Patients applied
Trial Officials
Martine MORISSET
Principal Investigator
University Hospital, Angers
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported