Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06971848

Evaluation of Skin Tests in Biotherapy Allergies

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck AL Amyloidosis Adenocarcinoma Adenoma Amyloidosis Bronchial Carcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Squamous Cell Cardiovascular Diseases Cholangiocarcinoma Chronic Disease Chronic Lymphocytic Leukemia Colonic Diseases Colorectal Adenocarcinoma Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Follicular Lymphoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Heart Cancer Heart Diseases Heart Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hepatocarcinoma Hodgkin's Lymphoma Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Melanoma Neoplasms Mesothelioma Mesothelioma, Malignant Metabolic Diseases Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Plasma Cell Neoplasms, Squamous Cell Nutritional and Metabolic Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Mesothelioma Pleural Neoplasms Proteostasis Deficiencies Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Bronchial Carcinomas Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, 49933, France

Location status: Recruiting

Location contact

Dominique LUET

SUB_INVESTIGATOR

Jonathan FAHRU

SUB_INVESTIGATOR

Martine MORISSET

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Yannick LE CORRE

SUB_INVESTIGATOR

Youssef OULKHOUIR

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug skin tests (investigating hypersensitivity to a biotherapy)

Other

allergologic skin tests (prick tests and intradermal tests)

Primary outcomes

  1. maximum usable concentration considered non-irritant

    Time frame: Day 1

    For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing.

Secondary outcomes

  1. possible occurrence of a delayed reaction at 48 hours post-testing

    Time frame: Day 2

    delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 48 hours after injection, or if a systemic reaction occurs following biotherapy administration.

  2. possible occurrence of a delayed reaction at one week post-testing

    Time frame: Day 7

    delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 1 week after injection

Study contacts

Contact information is provided by the study sponsor or research team.

Anthéa LOIEZ

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Martine MORISSET

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: ETCABIO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 14, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.