A study that compares Depigoid Olea (a medication to treat olive pollen allergies) and placebo in patients who have a runny nose and pink and itchy eyes due to olive pollen allergy.

Trial details

Who runs it

LETI Pharma S.L.U.

Trial code

EU 2026-525840-13-00

Record updated

2026. november 6.

Original description

Evaluation of the clinical efficacy of allergen immunotherapy with olive allergens assessed by the change in the combined symptom and medication score (range 0–6, collected via a mobile app) during the peak season for olive pollen, compared to the placebo after at least eight treatment injections.Read full original descriptionShow less

Phase III, double blind, placebo controlled, clinical trial to evaluate the efficacy and safety of Depigoid Olea europaea (1000 DPP/mL), a depigmented polymerised allergen extract of olive pollen, compared with placebo in patients with moderate to severe allergic rhinoconjunctivitis with or without asthma due to olive pollen allergy.

Evaluation of the clinical efficacy of allergen immunotherapy with olive allergens assessed by the change in the combined symptom and medication score (range 0–6, collected via a mobile app) during the peak season for olive pollen, compared to the placebo after at least eight treatment injections.

Inclusion: Patients aged ≥ 5 years; Patients suffering from moderate to severe allergic rhinitis for at least the two previous pollen seasons, with or without mild to moderate asthma at the time of immunotherapy administration, caused by clinically relevant sensitization to olive pollen, confirmed by: a. Skin prick test ≥ 3 mm against olive pollen mix. b. Specific IgE level > 0.7 kU/L against olive pollen. c. Specific IgE level > 0.7 kU/L against Ole e1. d. Positive CPT against olive pollen (maximum concentration 1/10); Asthmatic patients must be controlled according to the GINA guidelines and have an FEV1 > 70% at the time of immunotherapy administration; Patients/legal representatives who have understood and signed the informed consent form or assent form; Patients or guardians must have a mobile phone compatible with the cSMS application and access to the Internet; Participants capable of complying with the study protocol; Patients must remain in their area of residence for most of the pollen season.

Exclusion: Previous treatment with AIT within the last 5 years; Any contraindication to subcutaneous specific allergen immunotherapy according to the product information; Participants who have required oral corticosteroids within the 12 weeks prior to inclusion. Short rescue courses (bursts) of systemic corticosteroids (≤10 days) are permitted, provided the last dose was ≥4 weeks prior to screening; Participants receiving immunosuppressive treatment (except topical immunosuppressants); Patients treated with biological therapies for T2-related diseases within the last 6 months; Uncontrolled asthma at the time of immunotherapy administration according to the Global Initiative for Asthma (GINA) guidelines (15), or uncontrolled asthma (exacerbations within 3 months prior to administration), including FEV1 <70% of baseline value; Participants with a history of severe adverse reactions during skin prick testing; Participants who are clinically unstable at the time of inclusion (acute asthma exacerbation, respiratory infection, low-grade fever, acute urticaria, etc.); Participants with chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions at skin test sites, or a history of hereditary angioedema. Participants with any condition representing an absolute contraindication to adrenaline administration (e.g., severe cardiac disease); Participants with any other potentially severe disease not related to rhinoconjunctivitis or asthma that may interfere with treatment or follow-up (e.g., epilepsy, psychomotor impairment, malformations, multiple surgeries, renal diseases); Participants with uncontrolled autoimmune diseases (thyroiditis, lupus, etc.), active malignancies, or a diagnosis of immunodeficiency; Participants whose condition prevents adequate collaboration and/or who present severe psychiatric disorders; Participants with a known allergy to vaccine components other than the olive allergens; Participants with lower respiratory tract diseases other than asthma, such as emphysema or bronchiectasis; Sensitisation to Alternaria alternata if Alt a 1 > 0.7 kU/L, regardless of clinical relevance; Sensitisation to other co-seasonal allergens: o Grass pollen / Phleum pratense sensitisation if skin prick test > 3 mm and IgE to Phl p 1 and/or Phl p 5 > 3.5 kU/L. o Parietaria sensitisation if skin prick test > 3 mm and Par j 2 > 3.5 kU/L (applicable in areas with Parietaria pollen, such as the Mediterranean coast). o Platanus acerifolia sensitisation if skin prick test positive and IgE to Pla a 1 > 3.5 kU/L in areas of Andalucia; First-degree relatives of the investigator; Sensitisation to house dust mites if clinically relevant; Sensitisation to animal epithelia in participants living with the animal or having regular contact; Pregnancy or patient willing to become pregnant during the study period; Nursing (lactation).

EU CTIS 2026-525840-13-00