Clinical trial • Phase III • Immunology|Respiratory
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
Phase III trial of PHLEUM PRATENSE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT; FESTUCA ELATIOR POLLEN, DEPIGMENTED POLYMERIZED EXTRACT; DACTYLIS GLOMERATA PO…
Overview
- Trial Therapeutic Area
- Immunology|Respiratory
- Trial Disease
- Allergic rhinoconjunctivitis|Asthma
- Trial Stage
- Phase III
- Drug Modality
- Other
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 18-11-2025
- First CTIS Authorization Date
- 25-03-2026
Trial design
Randomised, open-label, depigoid forte grass-mix (3000 dpp/ml) (subcutaneous) and depigoid grass-mix (1000 dpp/ml) (subcutaneous) versus placebo (the solvent used in the imp formulation; suspension). at least 8 injections of treatment are required prior to the primary efficacy assessment; specific dosing schedule details not specified in the provided data.-controlled Phase III trial in Portugal, Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Depigoid FORTE Grass-Mix (3000 DPP/ml) (subcutaneous) and Depigoid Grass-Mix (1000 DPP/ml) (subcutaneous) versus placebo (the solvent used in the IMP formulation; suspension). At least 8 injections of treatment are required prior to the primary efficacy assessment; specific dosing schedule details not specified in the provided data.
- Target Sample Size
- 324
- Trial Duration For Participant
- 156
Eligibility
Recruits 324 paediatric patients.
- Pregnancy Exclusion
- Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing 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: o has practiced adequate contraception for 1 month prior to study intervention administration, and o has a negative pregnancy test on the first day of study intervention administration, and o has agreed to continue adequate contraception during the entire study treatment period (see Section 10.4).
- Vulnerable Population
- Includes children aged ≥5 years. Informed consent must be signed by participants or legal representatives; assent is required for minors. Age-specific assent and parental consent documents are provided (Assent 5-11, Assent 12-17, Parental ICF). Subject information and ICF documents and assent forms are available in English, Spanish and Portuguese.
Inclusion criteria
- {"criterion_text":"- Participants aged ≥5 years of age at the time of signing consent or assent.\n- Participants suffering from moderate or severe allergic rhinoconjunctivitis (ARIA)\n- Asthmatic participants must be, in the Investigator’s judgement, with controlled disease according to Global Initiative on Asthma (GINA) guidelines\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 hospitalization for worsening disease during the 28 days before enrolment.\n- Agree to actively stay in contact with the trial site for the duration of the trial for the participant’s own safety"}
Exclusion criteria
- {"criterion_text":"- Previous treatment with any type of AIT in the previous 5 years\n- Sensitisation to Alternaria alternata\n- Sensitisation to mites if clinically relevant\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. Nonchildbearing 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: o has practiced adequate contraception for 1 month prior to study intervention administration, and o has a negative pregnancy test on the first day of study intervention administration, and o has agreed to continue adequate contraception during the entire study treatment period (see Section 10.4).\n- Lactating.\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 trial.\n- 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).\n- 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).\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 angioedema.\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- 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 allergen extract.\n- Participants with chronic lower airway diseases other than asthma such as emphysema or bronchiectasis.\n- Direct relatives of the Investigator."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Mean combined Symptom and Medication Score (cSMS) collected through a mobile App (0-6) during peak grass pollen season; medication score defined as: 0 no medication; 0.5 antihistamine eye drops; 1 oral antihistamine; 1.5 intranasal corticosteroid. Symptom score details referenced to protocol."}
Secondary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Absolute values and changes from baseline during active pollen season comparing groups; includes mean cSMS during whole season, asthma symptoms and asthma medication score; further details in Protocol."}
Other endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change in amount of allergen required to obtain a positive Conjunctival Provocation Test (CPT) after the pollen season compared with baseline measurement."}
Recruitment
- Planned Sample Size
- 324
- Recruitment Window Months
- 42
- Consent Approach
- Informed consent is required from participants or legal representatives. For minors, parental/legal representative informed consent (Parental ICF) is required and assent is obtained from children (Assent forms for ages 5-11 and 12-17 are provided). Optional biomarker ICF is available. Subject information sheets and consent/assent documents are available in English, Spanish and Portuguese.
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 324
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
- 3
- Number Of Participants
- 56
Sites
- Site Name
- Hospital Particular do Algarve S.A.
- Department Name
- Immunoallergology
- Contact Person Name
- Natacha Santos
- Contact Person Email
- natacha.santos@ulsalg.min-saude.pt
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Immunoallergology
- Contact Person Name
- André Moreira
- Contact Person Email
- u003615@chsj.min-saude.pt
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Immunoallergology
- Contact Person Name
- Paula Leiria Pinto
- Contact Person Email
- pleiriapinto.imunoalergologia@ulssjose.min-saude.pt
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
- 29
- Number Of Participants
- 268
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Allergology
- Contact Person Name
- María del Carmen Dieguez
- Contact Person Email
- mcarmen.dieguez@salud.madrid.org
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Allergology
- Contact Person Name
- Antonio Ramón Sánchez
- Contact Person Email
- aramon82@gmail.com
- Site Name
- Hospital Central De La Cruz Roja San Jose Y Santa Adela
- Department Name
- Allergology
- Contact Person Name
- José Julio Laguna Martinez
- Contact Person Email
- josejuliolaguna@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Allergology
- Contact Person Name
- Ismael García Moguel
- Contact Person Email
- jfcrespo@salud.madrid.org
- Site Name
- Hospital Universitario De Guadalajara SESCAM
- Department Name
- Allergology
- Contact Person Name
- Andrea Garban
- Contact Person Email
- agarban@sescam.jccm.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Allergology
- Contact Person Name
- Maria Milagros Lázaro Sastre
- Contact Person Email
- milagroslazaro@saludcastillayleon.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Allergology
- Contact Person Name
- Lorena Soto Retes
- Contact Person Email
- sotoretes@gmail.com
- Site Name
- Hospital Nuestra Senora De Sonsoles
- Department Name
- Allergology
- Contact Person Name
- Sara Acero
- Contact Person Email
- sacero@hnss.sacyl.es
- Site Name
- Complexo Hospitalario Universitario De Pontevedra
- Department Name
- Allergology
- Contact Person Name
- Irene Fernández Franco
- Contact Person Email
- irenefernandezfranco@gmail.com
- Site Name
- Hospital Virgen De La Luz
- Department Name
- Allergology
- Contact Person Name
- Antonio Moreno Fernández
- Contact Person Email
- doctorertony@hotmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Allergology
- Contact Person Name
- Carlos Blanco Guerra
- Contact Person Email
- cblanque@gmail.com
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Allergology
- Contact Person Name
- Francisco Javier Ruano Pérez
- Contact Person Email
- fjavier.ruano@salud.madrid.org
- Site Name
- Hospital Nuestra Senona Del Prado
- Department Name
- Allergology
- Contact Person Name
- Álvaro Moreno Ancillo
- Contact Person Email
- alanaro@telefonica.net
- Site Name
- Hospital Universitario Infanta Elena
- Department Name
- Allergology
- Contact Person Name
- Isabel Elías
- Contact Person Email
- isabel.elias@quironsalud.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Allergology
- Contact Person Name
- María José Torres
- Contact Person Email
- mjtorresj@gmail.com
- Site Name
- Consorci Sanitari De Terrassa
- Department Name
- Allergology
- Contact Person Name
- Marta Viñas Domingo
- Contact Person Email
- mvinas@cst.cat
- Site Name
- Clínica Dermatología y Alergia (Badajoz)
- Department Name
- Dermatology and Allergy
- Contact Person Name
- Iran Sanchez Ramos
- Contact Person Email
- iran120@hotmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Allergology
- Contact Person Name
- Sergio Sánchez Fernández
- Contact Person Email
- ssanchezf@unav.es
- Site Name
- Consorcio Hospital General Universitario De Valencia
- Department Name
- Allergology
- Contact Person Name
- Rubén Félix Toledo
- Contact Person Email
- felix_rub@gva.es
- Site Name
- Hospital Universitario De Fuenlabrada
- Department Name
- Allergology
- Contact Person Name
- Juan María Beitia
- Contact Person Email
- beitiajm@yahoo.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Allergology
- Contact Person Name
- Virginia De Luque
- Contact Person Email
- virginiadeluque@hotmail.com
- Site Name
- Hospital Universitario Del Sureste - Empresa Publica Hosptial Del Sureste
- Department Name
- Allergology
- Contact Person Name
- Beatriz Huertas
- Contact Person Email
- bhuertas@salud.madrid.org
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Allergology
- Contact Person Name
- Alfredo Iglesias Cadarso
- Contact Person Email
- aiglesiasc.hpth@salud.madrid.org
- Site Name
- Hospital General Universitario De Albacete
- Department Name
- Allergology
- Contact Person Name
- Miguel Torrecillas Toro
- Contact Person Email
- mtorrecillast@sescam.jccm.es
- Site Name
- Hospital Universitario San Juan De Alicante
- Department Name
- Allergology
- Contact Person Name
- Mónica Antón Gironés
- Contact Person Email
- manton@vinaloposalud.com
- Site Name
- Hospital General Universitario De Castellon
- Department Name
- Allergology
- Contact Person Name
- Ernesto Enrique Miranda
- Contact Person Email
- eenriquemiranda@hotmail.com
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Allergology
- Contact Person Name
- Jesús Miguel García Menaya
- Contact Person Email
- jesusmiguel.garcia@salud-juntaex.es
- Site Name
- Hospital Universitario General De Villalba
- Department Name
- Allergology
- Contact Person Name
- Ignacio Esteban Gorgojo
- Contact Person Email
- igestebang@gmail.com
- Site Name
- Consorci Hospitalari De Vic
- Department Name
- Allergology
- Contact Person Name
- Gemma Vicens
- Contact Person Email
- gvicensn@clinic.cat
Sponsor
Primary sponsor
- Full Name
- LETI Pharma S.L.U.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Contract research organisations
- Name
- Iqvia Biotech Limited
- Responsibilities
- Sponsor duties codes: 1,11,12,13,2,5,6,8
- Name
- ClinCompetence Cologne GmbH
- Responsibilities
- APP to collect the CSMS
Third parties
- {"country":"Germany","full_name":"ClinCompetence Cologne GmbH","duties_or_roles":"APP to collect the CSMS","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"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"IWRS, eCOA","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Distefar Del Sur S.L.","duties_or_roles":"Symptomatic medication Supplier","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"Sponsor duties codes: 1,11,12,13,2,5,6,8","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Depigoid FORTE Grass-Mix (3000 DPP/ml)
- Active Substance
- 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
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised (product dictionary entry present)
- Maximum Dose
- 5 ml
- Investigational Product Name
- Depigoid Grass-Mix (1000 DPP/ml)
- Active Substance
- 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
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- Authorised (product dictionary entry present)
- Maximum Dose
- 5 ml
- Investigational Product Name
- The placebo to be used in the clinical trial is the solvent used in the investigational medicinal products’ (IMPs) formulation. The resulting product is a suspension.
- Modality
- Other
- Authorisation Status
- Not applicable / Sponsor-provided placebo
- Investigational Product Name
- Conjunctival Provocation Test Grass-Mix LETI 30 HEP/ml
- Active Substance
- PHLEUM PRATENSE POLLEN EXTRACT; LOLIUM PERENNE POLLEN EXTRACT; POA PRATENSIS POLLEN EXTRACT; FESTUCA ELATIOR POLLEN EXTRACT; DACTYLIS GLOMERATA POLLEN EXTRACT
- Modality
- Other
- Routes Of Administration
- OCULAR USE
- Route
- OCULAR USE
- Authorisation Status
- Authorised (product dictionary entry present)
- Maximum Dose
- 33.33 DF dosage form
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