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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521736-10-00

Enrollment

324

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 controlled asthma

Brief summary

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

Detailed description

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

Interventions

DRUGDepigoid Grass-Mix (1000 DPP/ml)

DRUGConjunctival Provocation Test Grass-Mix LETI 30 HEP/ml

DRUGThe 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.

DRUGDepigoid FORTE Grass-Mix (3000 DPP/ml)

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

—

Outcome results

None listed

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