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A prospective, randomized, double-blind, placebo-controlled, multicentre, dose-finding clinical trial with polymerised mannan-conjugated allergoid Dactylis glomerata/Phleum pratense administered subcutaneously to patients with grass pollen-induced allergic rhinitis or rhinoconjunctivitis.

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524580-21-00
Enrollment
450
Registered
2026-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-29

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

Conditions

Grass pollen induced allergic rhinitis or rhinoconjunctivitis

Brief summary

Mean daily Combined Symptom and Medication Score (CSMS, as defined in the EAACI position paper by Pfaar et al., 2014) over the peak grass pollen season 2027.

Interventions

DRUGSuspension
DRUGPlacebo is identical in appearance an condition to the investigational medicinal product.
DRUGHAL Allergy Prick Test Wiesenlieschgras
DRUGMannan-conjugated allergoid (polymerized) Phleum pratense and Dactylis glomerata parenteral vaccine
DRUGHAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle
DRUGHAL Allergy Prick Test Alternaria alternata
DRUGALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest

Sponsors

Inmunotek S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Mean daily Combined Symptom and Medication Score (CSMS, as defined in the EAACI position paper by Pfaar et al., 2014) over the peak grass pollen season 2027.

Outcome results

None listed

Source: EU CTIS · Data processed: May 30, 2026