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Clinical trial to evaluate the efficacy and safety of Depigoid DUO Grass-Mix/Olea (1000 DPP/mL + 1000 DPP/mL) compared with placebo in patients suffering from allergic rhinoconjunctivitis with or without asthma due to clinically relevant sensitisation to grass and olive pollen.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521709-42-00
Enrollment
343
Registered
2026-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinoconjunctivitis with or without asthma due to clinically relevant sensitisation to grass and olive pollen.

Brief summary

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

Detailed description

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, 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), Total and specific IgE and IgG4 (through InmunoCAP) to Grass-Mix and Phleum pratense, Phl p1, Phl p5, and Olea europaea, Olee1, Total IgA2

Interventions

DRUGConjunctival Provocation Test Olea europaea LETI 30 HEP/ml
DRUGDepigoid DUO Grass-Mix/Olea (1000 DPP/ml + 1000 DPP/ml)
DRUGPLACEBO (Depigoid): the placebo is the solvent used in the investigational medicinal products’ (IMP) formulation. The resulting product is a suspension.

Sponsors

LETI Pharma S.L.U.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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, 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), Total and specific IgE and IgG4 (through InmunoCAP) to Grass-Mix and Phleum pratense, Phl p1, Phl p5, and Olea europaea, Olee1, Total IgA2

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 26, 2026