Evaluation of Skin Tests in Biotherapy Allergies

NCT ID: NCT06971848

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-10-31

Brief 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

Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck; Melanoma Neoplasms; Small Cell Bronchial Carcinomas; Bronchial Carcinoma; Pleural Mesothelioma; Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Follicular Lymphoma; Myeloma; AL Amyloidosis; Hepatocarcinoma; Colorectal Cancer; Esophageal Squamous Cell Carcinoma; Heart Cancer; Cholangiocarcinoma; Colorectal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study Arm

Group Type: EXPERIMENTAL

Drug skin tests (investigating hypersensitivity to a biotherapy)

Intervention Type: OTHER

allergologic skin tests (prick tests and intradermal tests)

Interventions

Drug skin tests (investigating hypersensitivity to a biotherapy)

allergologic skin tests (prick tests and intradermal tests)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine MORISSET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

CHU Angers

Angers, , France

Countries

France

Central Contacts

Martine MORISSET

Role: CONTACT

martine.morisset@chu-angers.fr

02 41 35 36 37 ext. +33

Anthéa LOIEZ

Role: CONTACT

DRCI-Promotion-Interne@chu-angers.fr

02 41 35 36 37 ext. +33

Facility Contacts

Martine MORISSET

Role: primary

martine.morisset@chu-angers.fr

02 41 35 36 37 ext. +33

Other Identifiers

49RC24_0373

Identifier Type: -

Identifier Source: org_study_id