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Withdrawn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

CTIS2025-520581-22-00

Acronym

PRO-RCT-GRAM-2025-01

Enrollment

120

Registered

2025-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-16

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

Serum values of total IgE, grass specific IgE and IgG4 at baseline and final visit. Serum Phl p1 and Phl p5 specific IgE and IgG4 values at baseline and final visit (V0 and V7).

Interventions

DRUGPLACEBO

DRUGBELTAVAC polymerized grass mix

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time 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

Measure	Time frame
Serum values of total IgE, grass specific IgE and IgG4 at baseline and final visit. Serum Phl p1 and Phl p5 specific IgE and IgG4 values at baseline and final visit (V0 and V7).	—

Countries

Poland, Spain

Outcome results

None listed

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