OLEA EUROPAEA POLLEN, DEPIGMENTED POLYMERIZED EXTRACT, PHLEUM PRATENSE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT, FESTUCA ELATIOR POLLEN, DEPIGMENTED POLYMERIZED EXTRACT, DACTYLIS GLOMERATA POLLEN, DEPIGMENTED POLYMERIZED EXTRACT, POA PRATENSIS POLLEN, DEPIGMENTED POLYMERIZED EXTRACT, LOLIUM PERENNE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT for Allergic rhinoconjunctivitis | Asthma

Inclusion criteria

• {"criterion_text":"- Participants aged ≥6 years of age at the time of signing consent or assent.\n- Participants suffering from moderate or severe allergic rhinoconjunctivitis\n- Asthmatic participants must be, in the investigator’s judgement, with controlled disease according to Global Initiative on Asthma (GINA) guidelines, no severe asthma exacerbations in the previous pollen season, and have a forced expiratory volume in 1 second (FEV1) ≥70% at the time of immunotherapy administration\n- Participants/legal representatives who have understood and signed the informed consent or informed assent (see Section 10.1.4).\n- Participants or guardians need to have a mobile phone which can support the cSMS App and access to internet and/or mobile service.\n- Participants who are able to remain at their usual place of residence for the majority of the pollen season.\n- Participants are capable of complying with the study protocol.\n- 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 hospitalisation for worsening disease during the 28 days before enrolment.\n- Agree to actively stay in contact with the study site for the duration of the study for the participant’s own safety."}

Exclusion criteria

• {"criterion_text":"- Previous treatment with any type of AIT in the previous 5 years.\n- Any contraindication for treatment with SC allergen specific immunotherapy according to information of product use.\n- Participants who have required systemic corticosteroids in the 12 weeks prior to the inclusion (screening) in the study.\n- Participants who have previously suffered a serious secondary reaction during the skin prick test (SRs after skin prick test [SPT], which can be classified using World Allergy Organisation 2010 (WAO-2010) reactions and serious according to regulatory definition of serious adverse reaction [SAR]).\n- Participants clinically unstable at the time of the inclusion (screening) in the study (acute asthmatic exacerbation, respiratory infection, febrile fever, acute urticaria, etc); rescreening is permitted (see Section 5.4).\n- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n- 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 angiooedema.\n- Participants with any condition that represents an absolute contraindication to the administration of adrenaline (heart disease, etc).\n- Participants undergoing immunosuppressive treatment (except topical immunosuppressants).\n- 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).\n- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n- Sensitisation to Alternaria alternata\n- Participants whose status prevents them from providing cooperation and/or who presents with severe psychiatric disorders\n- Participants with known allergy to other vaccine components different from grass or olive allergen extract.\n- Participants with chronic lower airway diseases other than asthma such as emphysema or bronchiectasis.\n- Direct relatives of the investigator\n- Sensitisation to dust mites\n- Sensitisation to epithelia if the participant lives or has frequent contact with animals.\n- Sensitisation to other co-seasonal allergens\n- Participants receiving treatment with biologics\n- Uncontrolled asthma at the time of immunotherapy administration, according to the GINA guidelines or unstable asthma\n- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy. Female participants of childbearing potential may be enrolled in the study, if the participant: -has practiced adequate contraception for 1 month prior to study intervention administration, and -has a negative pregnancy test on the first day of study intervention administration, and -has agreed to continue adequate contraception during the entire study treatment period (see Section 10.3).\n- Lactating."}

Primary endpoints

• {"endpoint_text":"- Mean cSMS (0-6) at peak grass and olive pollen season comparing active and placebo groups after at least 8 injections of treatment. - Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid - Symptom score: 0 none, 1 mild, 2 moderate, 3 severe: runny nose, sneezing, itchy nose, nasal congestion, itchy eyes, and tearing","definition_or_measurement_approach":"Combined symptom and medication score (cSMS) 0-6 collected through a mobile App during the peak grass and olive pollen season after ≥8 injections. Medication score and symptom score are defined as above; cSMS is the primary efficacy measure and is calculated from the symptom and medication scores collected via the participant mobile application."}

Secondary endpoints

• {"endpoint_text":"- 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 and olive pollen season -Asthma symptoms and asthma medication score -Severity of rhinoconjunctivitis (ARIA) and asthma (GINA) -QoL (RQLQ/pRQLQ/ AdolRQLQ, AQLQ/PAQLQ)-ESPIA-VAS-ACT..Please refer to the Protocol for further details","definition_or_measurement_approach":"Absolute values and change from baseline for mean cSMS over the entire pollen season; asthma symptom and medication scores; severity classifications according to ARIA (rhinoconjunctivitis) and GINA (asthma); quality of life measured by RQLQ/pRQLQ/AdolRQLQ or AQLQ/PAQLQ; additional scales ESPIA, VAS, ACT. Further measurement details referenced in the Protocol."}
• {"endpoint_text":"- In the subset of participants with asthma, during the pollen peak and throughout the pollen season:-Lung function measured by FEV1 when possible-Quality of life measured by the AQLQ for adults or the paediatric version (PAQLQ)-Asthma control measured by the ACT for adults or the paediatric version (pACT)-Asthma severity as classified by the GINA guidelines -Asthma exacerbations (Number,severity, and duration)","definition_or_measurement_approach":"FEV1 measurements where possible; QoL by AQLQ or PAQLQ; asthma control by ACT or pACT; asthma severity per GINA; record number, severity and duration of asthma exacerbations in the asthma subset during peak and full pollen season."}
• {"endpoint_text":"- Total and specific IgE and IgG4 (through InmunoCAP) to Grass-Mix and Phleum pratense, Phl p1, Phl p5, and Olea europaea, Olee1","definition_or_measurement_approach":"Serologic immunologic endpoints measured by ImmunoCAP: total and specific IgE and IgG4 to Grass-Mix, Phleum pratense (Phl p1, Phl p5) and Olea europaea (Olee1)."}
• {"endpoint_text":"- Total IgA2","definition_or_measurement_approach":"Total IgA2 measured in blood samples according to protocol-specified laboratory methods."}

Portugal

Earliest CTIS Part Ii Submission Date

05-03-2026

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

20

Number Of Sites

4

Number Of Participants

60

Spain

Earliest CTIS Part Ii Submission Date

05-03-2026

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

20

Number Of Sites

30

Number Of Participants

283

Primary sponsor

Full Name

LETI Pharma S.L.U.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

IWRS eCOA

Name

Iqvia Biotech Limited

Responsibilities

sponsorDuties codes: 1,11,12,13,2,5,6,8

Name

ClinCompetence Cologne GmbH

Responsibilities

APP to collect the CSMS

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"IWRS eCOA","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"ClinCompetence Cologne GmbH","duties_or_roles":"APP to collect the CSMS","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"sponsorDuties codes: 1,11,12,13,2,5,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Distefar Del Sur S.L.","duties_or_roles":"Symptomatic medication Supplier","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Eurofins Megalab S.A.","duties_or_roles":"Central Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Docs24 Limited","duties_or_roles":"Printing Company","organisation_type":"Pharmaceutical company"}