2025-521736-10-00
Recruiting
Phase 3
Clinical trial to evaluate the efficacy and safety of two concentrations (1000DPP/ml and 3000DPP/ml) of depigmented polymerized allergen extracts of Depigoid GrassMix / Depigoid FORTE GrassMix compared to placebo, in patients suffering from allergic rhinoconjunctivitis with or without controlled asthma due to clinically relevant sensitization to grass pollen
LETI Pharma S.L.U.32 sites in 2 countries324 target enrollmentStarted: April 1, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- LETI Pharma S.L.U.
- Enrollment
- 324
- Locations
- 32
- Primary Endpoint
- Double-Blind, Randomised, Controlled Phase: Mean cSMS (0-6) at peak grass pollen season comparing active and placebo groups after at least 8 injections of treatment. o Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid o Symptom score:Please refer to the protocol for further details
Overview
Brief Summary
Double-Blind, Randomised,Controlled Phase Primary Efficacy: Assessment of the clinical efficacy of grasses allergen immunotherapy for each concentration, evaluated by the combined symptom and medication score (0-6 collected through a mobile App) during the peak grass pollen compared with placebo after at least 8 injections of treatment. Open-label Phase Primary Efficacy: Assessment of the clinical efficacy of grasses allergen immunotherapy, evaluated by the change in the amount of allergen necessary to obtain a positive CPT (after the pollen season) compared to baseline.
Eligibility Criteria
- Ages
- 0 years to 65+ years (18-64 Years, 65+ Years, 0-17 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged ≥5 years of age at the time of signing consent or assent.
- •Participants suffering from moderate or severe allergic rhinoconjunctivitis (ARIA)
- •Asthmatic participants must be, in the Investigator’s judgement, with controlled disease according to Global Initiative on Asthma (GINA) guidelines
- •Participants/legal representatives who have understood and signed the informed consent or informed assent (see Section 10.1.4).
- •Participants or guardians need to have a mobile phone which can support the cSMS App and access to internet and/or mobile service.
- •Participants who are able to remain at their usual place of residence for the majority of the pollen season.
- •Participants are capable of complying with the study protocol.
- •Preexisting stable disease is allowed unless otherwise specified in the exclusion criteria in Section 5.2, as established by medical history and physical examination and as determined by the Investigator. Preexisting stable disease is defined as not requiring significant change in therapy or hospitalization for worsening disease during the 28 days before enrolment.
- •Agree to actively stay in contact with the trial site for the duration of the trial for the participant’s own safety
Exclusion Criteria
- •Previous treatment with any type of AIT in the previous 5 years
- •Any contraindication for treatment with SC allergen specific immunotherapy according to information of product use.
- •Participants who have required systemic corticosteroids in the 12 weeks prior to the inclusion (screening) in the trial.
- •Participants who have previously suffered a serious secondary reaction during the skin prick test (systemic reactions after SPT, which can be classified using World Allergy Organisation 2010 (WAO-2010) reactions and serious according to regulatory definition of serious adverse reaction).
- •Participants clinically unstable at the time of the inclusion (screening) in the trial (acute asthmatic exacerbation, respiratory infection, febrile fever, acute urticaria, etc); rescreening is permitted (see Section 5.4).
- •Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.
- •Participants with Investigator-determined chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
- •Participants with any condition that represents an absolute contraindication to the administration of adrenaline (heart disease, etc).
- •Participants undergoing immunosuppressive treatment (except topical immunosuppressants).
- •Participants with any other disease not associated with the moderate or severe rhinoconjunctivitis or asthma, but of potential severity and that could interfere with the treatment and follow-up (epilepsy, psychomotor deterioration, malformations, multi-operated, kidney diseases, etc).
Outcomes
Primary Outcomes
Double-Blind, Randomised, Controlled Phase: Mean cSMS (0-6) at peak grass pollen season comparing active and placebo groups after at least 8 injections of treatment. o Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid o Symptom score:Please refer to the protocol for further details
Double-Blind, Randomised, Controlled Phase: Mean cSMS (0-6) at peak grass pollen season comparing active and placebo groups after at least 8 injections of treatment. o Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid o Symptom score:Please refer to the protocol for further details
Secondary Outcomes
- Double-Blind, Randomised, Controlled Phase: Absolute values and changes from baseline (if applicable) during active pollen season comparing active and placebo groups after at least 8 injections: - Mean cSMS during the whole grass pollen season-Asthma symptoms and asthma medication score. Please refer to the Protocol for further details.Open-label Phase:Please refer to the Protocol for further details
Investigators
Mónica Ruiz García
Scientific
LETI Pharma S.L.U.
Study Sites (32)
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