Evaluation of Skin Tests in Biotherapy Allergies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Drug skin tests (investigating hypersensitivity to a biotherapy)

    Other intervention

    allergologic skin tests (prick tests and intradermal tests)

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Study ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

maximum usable concentration considered non-irritant

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.

Time frame
Day 1

Secondary outcomes

1

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

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.

Time frame
Day 2
2

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

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

Time frame
Day 7

Other outcomes

Sponsors and contacts

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