Evaluation of Skin Tests in Biotherapy Allergies

Sponsor
University Hospital, Angers
Study ID
NCT06971848
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Drug skin tests (investigating hypersensitivity to a biotherapy) — OTHER
    allergologic skin tests (prick tests and intradermal tests)

Study Details

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.

Key Dates

First listed
May 14, 2025
Start date
Jun 17, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Study Arm

Primary Outcome Measure

maximum usable concentration considered non-irritant [ Time Frame: Day 1 ]

Central Contacts

Find similar trials

Nationwide
Leukemia (other) trialsColorectal cancer trialsMultiple myeloma trialsOncology trialsBlood cancer trialsGI oncology trials

Related Studies