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MM09 immunotherapy for mite-induced allergic rhinitis and asthma
NCT05641272Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2023
- Primary completion
- Jun 2026
- Countries
- 1
- Sponsor
- Inmunotek
- Modality
- Split/Subunit Vaccines, Allergy Immunotherapy
- Drugs
- Clustoid MM09
- Conditions
- allergic rhinitis (AR)allergic rhinoconjunctivitis (ARC)allergic asthma
01
Overview
Phase 3, randomised, double-blind trial of Clustoid MM09 in allergic rhinitis (AR), allergic rhinoconjunctivitis (ARC) and allergic asthma (3 arms), sponsored by Inmunotek. Primary endpoint: Rhinitis/rhinoconjunctivitis Combined Symptom and Medication Score at 6 months. Planned start Nov 2023; status: not yet recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
MM09 3,000 UTm/mL
MM09 3,000 UTm/mL 2 sprays daily
MM09 9,000 UTm/mL
MM09 9,000 UTm/mL 2 sprays daily
Placebo
Placebo 2 sprays daily
03
Who it enrols
Patients aged 12-60 with moderate-severe allergic rhinitis/rhinoconjunctivitis due to house dust mites, with or without controlled mild-moderate asthma. Must have positive skin prick test and specific IgE >= 3.5 kU/L.
04
Endpoints
Primary
Rhinitis/rhinoconjunctivitis Combined Symptom and Medication Score
Secondary
Rhinitis/Rhinoconjunctivitis Symptom Score
Rhinitis/Rhinoconjunctivitis Medication Score
Asthma Combined Symptom and Medication Score
Asthma Symptom Score
Asthma Medication Score
Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score
Asthma and Rhinitis/Rhinoconjunctivitis Medication Score
Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score
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