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A Prospective, Randomized, Open-label, Multicentre Study to Compare the Safety of PURETHAL Mites Mixture 50,000 AUeq/mL Rush Up-Dosing Regimen with the Conventional Up-Dosing Regimen in Adult Participants with Allergic House Dust Mite Rhinitis/Rhinoconjunctivitis with or without Asthma

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526908-72-00
Enrollment
15
Registered
2026-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-14

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

Conditions

Allergic House Dust Mite Rhinitis/Rhinoconjunctivitis with or without Asthma

Brief summary

Proportion of participants with at least one TEAE during the up-dosing phase of the trial

Detailed description

Proportion of participants with at least one TEAE during the trial, Proportion of participants with at least one treatment related TEAE, by maximum intensity, Proportion of participants with at least one local TEAE, by maximum intensity, Number of TEAEs per injection/injection visit, Local injection-site swelling/redness per injection by size category, Proportion of participants with at least one systemic TEAE, by the maximum grade, Proportion of participants with at least one severe TEAE, Proportion of participants with TEAEs leading to dose repetition, dose reduction, or permanent discontinuation, Proportion of participants with at least one early (within 30 minutes after injection) local TEAE, Proportion of participants with at least one early (within 30 minutes after injection) systemic TEAE, Proportion of participants with at least one late (> 30 minutes and up to 24 hours after injection) local TEAE, Proportion of participants with at least one late (> 30 minutes and up to 24 hours after injection) systemic TEAE, Distribution of overall tolerability assessment scores as evaluated by the Investigator, Distribution of overall tolerability assessment scores as evaluated by the participant, Proportion of participants who achieve the planned 0.5 mL maintenance dose within the allowed number of up-dosing injections, Proportion of participants who cannot achieve the planned 0.5 mL maintenance dose within the allowed number of up-dosing injections, Proportion of participants who cannot achieve the planned 0.5 mL maintenance dose within the allowed number of up-dosing injections due to a systemic reaction of grade II or higher within 24 hours after any up dosing injection

Interventions

Sponsors

HAL Allergy B.V.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Proportion of participants with at least one TEAE during the up-dosing phase of the trial—

Secondary

MeasureTime frame
Proportion of participants with at least one TEAE during the trial, Proportion of participants with at least one treatment related TEAE, by maximum intensity, Proportion of participants with at least one local TEAE, by maximum intensity, Number of TEAEs per injection/injection visit, Local injection-site swelling/redness per injection by size category, Proportion of participants with at least one systemic TEAE, by the maximum grade, Proportion of participants with at least one severe TEAE, Proportion of participants with TEAEs leading to dose repetition, dose reduction, or permanent discontinuation, Proportion of participants with at least one early (within 30 minutes after injection) local TEAE, Proportion of participants with at least one early (within 30 minutes after injection) systemic TEAE, Proportion of participants with at least one late (> 30 minutes and up to 24 hours after injection) local TEAE, Proportion of participants with at least one late (> 30 —

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 15, 2026