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NCT06778213: RANSES

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

Recruiting now Phase 4 Last updated 28 January 2025
What this trial tests

Phase 4 trial testing NovoHelisen Depot in Allergic Rhinoconjunctivitis in 67 participants. Currently enrolling.

Timeline
2 November 2024
Primary endpoint
2 April 2026
1 December 2026

Quick facts

Lead sponsorWroclaw Medical University
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment67
Start date2 November 2024
Primary completion2 April 2026
Estimated completion1 December 2026
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Wroclaw Medical University

Who can join

Adults 18 to 65, any sex, with Allergic Rhinoconjunctivitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Wroclaw Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06778213.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing