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MK-8237 Phase 2b in HDM Allergic Rhinitis
NCT01644617Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2012
- Primary completion
- Aug 2013
- Sponsor
- ALK-Abelló
- Modality
- Allergy Immunotherapy
- Conditions
- allergic rhinitis (AR)allergic rhinoconjunctivitis (ARC)
01
Overview
Phase 2, randomised, double-blind trial of House dust mite allergen extract in allergic rhinitis (AR) and allergic rhinoconjunctivitis (ARC) (3 arms), sponsored by ALK-Abelló. Primary endpoint: Total Nasal Symptom Score at 24 weeks. Started Oct 2012; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo sublingual tablet daily
MK-8237 6 DU
MK-8237 6 DU sublingual tablet daily
MK-8237 12 DU
MK-8237 12 DU sublingual tablet daily
03
Who it enrols
Adults with a history of house dust mite-induced allergic rhinitis/rhinoconjunctivitis for at least 1 year. Patients with unstable asthma, other significant allergies (animal dander, molds, seasonal), or recent immunotherapy are excluded.
04
Endpoints
Primary
Total Nasal Symptom Score
Secondary
Total Nasal Symptom Score
Total Symptom Score
Total Ocular Symptom Score
HDM-specific Immunoglobulin E
HDM-specific Immunoglobulin G4
Adverse Events
05
Results
Primary endpoints met
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