International, multicenter, blinded phase III clinical trial to assess the diagnostic efficacy of the skin prick test from ROXALL (SPT-RX) with different allergen extract solutions for in vivo diagnosis of IgE mediated allergies

Prior treatment

• Patients who are using drugs that may interfere with the SPTs (according to Bousquet J. 1992, Rüeff F. 2011 and Heinzerling et al. 2013)
• Patients receiving allergen immunotherapy (AIT) or who received AIT in the past to any of the allergen extracts under investigation or to any cross-reactive allergen extract.
• Patients receiving treatment with beta-blockers.
• Completed or ongoing treatment with an anti-IgE-antibody (like Omalizumab) and/or checkpoint inhibitor.

Other illness

• Skin disorders such as dermographism, atopic dermatitis, urticaria, cutaneous mastocytosis or tattoos at the test application area.
• Contraindication for adrenaline (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma).
• Patients with any severe psychiatric and psychological disorders, including impairment of cooperation (e. g., alcohol or drug abuse).
• In addition, for patients with a negative case history (“true non-allergic” patients): • Patients sensitized to any allergen source with demonstrated cross-reactivity with the allergen sources under investigation.
• Patients with hypersensitivity to any of the excipients of the SPT-RX allergen extract solutions under investigation.
• Any severe generalised disease (liver, kidney, heart, metabolic disease) or autoimmune disease, immune-defect, including immunosuppression, immune-complex-induced immunopathy, or any infection or inflammation of the respiratory tract at the time of inclusion.

Other

• Patients with any other contraindications for performing skin prick test.
• Risk of non-compliance by the patient with the study procedures
• Relationship or dependence with the sponsor and/or investigator, legal incapacity, or patients who are jurisdictional or governmentally institutionalized.
• Subjects currently participating in another clinical trial.
• Only for asthmatic patients, severe, partly controlled or uncontrolled asthma according to the GINA guideline (Global Initiative for Asthma, 2025) or forced expiratory volume (FEV1) in one second ≤ 80 % of predicted normal value or known high degree of bronchial hyperreactivity.
• Patients at high risk of anaphylaxis according to their medical history.
• Pregnancy and/or breastfeeding.

• Patients who signed and dated informed consent form obtained prior to any study-specific examination.
• Female or male patients between 18 and 65 years of age at the time of signing the informed consent form.
• Positive result (≥ 3 mm) in a skin prick test performed with a positive control (histamine dihydrochloride 10 mg/mL) used in routine clinical practice, and negative result (< 2 mm) in a skin prick test performed with a negative control (glycerinated phenolated saline solution) used in routine clinical practice.
• Assumed compliance and ability of the patient to understand the patient's diary and to follow the instructions of the study staff.
• Patients suffering from rhinitis / rhinoconjunctivitis, with well-controlled mild-to-moderate asthma or without asthma, due to the exposure to any of the allergen sources under investigation, for at least 2 years in case of seasonal allergenic sources or for at least 1 year in case of perennial allergenic sources.
• Patients with a previous diagnosis of IgE-mediated allergy (type I) to any of the allergen sources under investigation verified by: a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 1, (0-3 scale), according to Pfaar et al. (2014), during the period of highest exposure to the allergen source preceding the enrolment and, a positive skin prick test (mean wheal sdiameter ≥ 3 mm) when tested with a biologically standardized extract ued in routine clinical practice and, specific IgE (CAP (EAST) class ≥ 3 (i. e. value ≥ 3.50 kU/L)
• In addition, for patients with a negative case history (“true non-allergic” patients) to any of the allergen extracts under investigation: • Non-atopic patients or patients sensitized to any allergen extract but those under investigation1 or any cross-reactive allergen source, verified by: a negative skin prick test (mean wheal diameter < 3d mm) to any of the allergen sources under investigation when tested with a biologically standardized extract prouct used in routine clinical practice and IgE (CAP (EAST) class < 1 (i. e. value < 0.35 kU/L) to the allergen source.