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Randomized, double-blind, placebo-controlled clinical trial to evaluate the optimal dose of Beltavac® with polymerized extract of grass pollen mixture in patients with allergic rhinoconjunctivitis associated or not with asthma.

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510033-28-00
Acronym
PRO RCT GRAM 2022
Enrollment
150
Registered
2024-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-14

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

Conditions

allergic rhinoconjunctivitis caused due to exposure to pollen grasses

Brief summary

Proportion of patients whose reactivity to the Conjunctival Provocation Test (CPT) with grass extract decreases between baseline and visit 7. It means that the titrated 10 – fold step allergen concentration required to develop a positive response is at least one dose higher.

Detailed description

Combined nasal and conjunctival symptoms and rescue medication score (CSMS) obtained during the peak pollen season through the Diary patient App. Nasal and conjunctival symptoms score obtained during the peak pollen season through the Diary patient App., Rhinoconjunctivitis daily medication score obtained during the peak pollen season through the Diary patient App.

Interventions

DRUGPLACEBO
DRUG-

Sponsors

Probelte Pharma S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Proportion of patients whose reactivity to the Conjunctival Provocation Test (CPT) with grass extract decreases between baseline and visit 7. It means that the titrated 10 – fold step allergen concentration required to develop a positive response is at least one dose higher.

Secondary

MeasureTime frame
Combined nasal and conjunctival symptoms and rescue medication score (CSMS) obtained during the peak pollen season through the Diary patient App. Nasal and conjunctival symptoms score obtained during the peak pollen season through the Diary patient App., Rhinoconjunctivitis daily medication score obtained during the peak pollen season through the Diary patient App.

Countries

Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026