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A multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy (Beltavac®) with Polymerized Allergenic Extract of a Mixture of Dermatophagoides and Blomia tropicalis in Patients with Allergic Rhinitis/rhinoconjunctivitis.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526105-15-00
Enrollment
174
Registered
2026-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-08

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

Conditions

Allergic rhinitis/rhinoconjunctivitis due to house dust mites exposure

Brief summary

Combined score of nasal symptoms and specific allergy medication (CSMR4) completed by the patient daily in the patient's electronic record in 4-week periods prior to visits 1 and 7 and 8-week periods prior to visit 13.

Detailed description

Rhinitis Symptoms Score, Specific Medication Scale score., Nasal and Ocular Symptom Scale score., Combined score of nasal, ocular, and medication symptoms (CSMR6)., Percentage of days without symptoms or medication., Visual analogue scale score on visits 1, 7 and 13 by the patient and investigator., RCAT questionnaire score on visits 1, 7 and 13., Specific rhinitis questionnaire score (mini-RQLQ) at visits 1, 7 and 13., Specific serum values ​​of IgE and IgG4 specific to Blomia, DPT and DF total, Der p1 and Der p2, Der p23, Der f1, Der f2 and Blo t5 at visits 0, 7 and 13.

Interventions

DRUGPLACEBO
DRUGBeltavac Polimerizado mezcla de Dermatophagoides pteronyssinus
DRUGDermatophagoides farinae y Blomia tropicalis (1:1:1)

Sponsors

Probelte Pharma S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Combined score of nasal symptoms and specific allergy medication (CSMR4) completed by the patient daily in the patient's electronic record in 4-week periods prior to visits 1 and 7 and 8-week periods prior to visit 13.

Secondary

MeasureTime frame
Rhinitis Symptoms Score, Specific Medication Scale score., Nasal and Ocular Symptom Scale score., Combined score of nasal, ocular, and medication symptoms (CSMR6)., Percentage of days without symptoms or medication., Visual analogue scale score on visits 1, 7 and 13 by the patient and investigator., RCAT questionnaire score on visits 1, 7 and 13., Specific rhinitis questionnaire score (mini-RQLQ) at visits 1, 7 and 13., Specific serum values ​​of IgE and IgG4 specific to Blomia, DPT and DF total, Der p1 and Der p2, Der p23, Der f1, Der f2 and Blo t5 at visits 0, 7 and 13.

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 9, 2026