Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Allergies

In brief

Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. However, evidence of the efficacy of this treatment is limited (small numbers, lack of validation with a control group, absence of double-blind evaluation of the primary endpoint in a challenge test against placebo). The aim of oral immunotherapy with raw apple is to improve the management of allergic patients by enabling them to acquire tolerance to raw apple and other rosacea.

Key facts

Study ID: NCT06771791
Run by: University Hospital, Strasbourg, France
People needed: 110
Starts: 2025-01-08
Expected to finish: 2027-05-05
Last updated by the study team: 2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient with allergic rhinitis to birch pollen.
Patient with an oral syndrome within 15 minutes of consuming at least one of the first 3 doses of raw apple in the V0 or V1 raw apple oral challenge test.
Evidence of sensitization to PR10 proteins in birch pollen and apple: positive prick tests to birch pollen and raw Golden apple and/or positive Bet v 1 and Mal d 1 specific IgE assays.
Subject affiliated to a social health insurance scheme
Subject able to understand the aims and risks of the research and to give dated and signed informed consent
For women of childbearing age: negative urine pregnancy test at inclusion visit

You may not qualify if…

Severe or uncontrolled asthma
Severe obstructive syndrome
Active neoplastic disease
Active autoimmune disease
Eosinophilic esophagitis or other active eosinophilic gastrointestinal pathologies
History of bariatric surgery
History of anaphylaxis to apples
Allergy to cooked apples
Contraindication to anti-histamines, corticoids, salbutamol, adrenaline
Other contraindication to an oral challenge test
Allergy to placebo ingredients
Presence of oral syndrome during consumption of placebo in the first oral challenge test
Allergenic immunotherapy to birch pollen in progress or completed less than 5 years ago
Current treatment with anti-IgE, anti-IL4/13, anti-IL5 or anti-TSLP biotherapy.
Impossibility of giving the subject informed information
Subject under court protection
Subject under guardianship or curatorship
Pregnancy

Where it is running

Hôpitaux Universitaires de Strasbourg — Strasbourg, France, France (enrolling)
Hopital François Mitterrand Chu Dijon — Dijon, France (enrolling)
Chu Jean Minjoz — Besançon, France
Hopital Maison Blanche Chu Reims — Reims, France

Full record on ClinicalTrials.gov

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