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Dose-ranging study of Pollinex Quattro Birch in seasonal allergic rhinoconjunctivitis
2012-004336-28Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2013
- Countries
- 1
- Sponsor
- Allergy Therapeutics PLC
- Modality
- Peptide-based Cancer Vaccines → Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Subcutaneous Immunotherapy → Allergy Immunotherapy → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Sublingual Immunotherapy → Allergy Immunotherapy → Therapeutic Vaccines → Vaccines & Immunotherapeutics
- Drugs
- depigoid birch
- Conditions
- seasonal allergic rhinitis (SAR)allergic rhinoconjunctivitis (ARC)
01
Overview
Phase 2, randomised, double-blind trial of depigoid birch in seasonal allergic rhinitis (SAR) and allergic rhinoconjunctivitis (ARC) (4 arms), sponsored by Allergy Therapeutics PLC. Primary endpoint: Change from baseline to post-treatment in total symptom score following conjunctival provocation test. Started Feb 2013; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Pollinex Quattro Birch 600 SU cumulative dose
Participants receive a lower cumulative dose regimen of Pollinex Quattro Birch totaling 600 SU.
Pollinex Quattro Birch 1550 SU cumulative dose
Participants receive a cumulative dose regimen of Pollinex Quattro Birch totaling 1550 SU.
Pollinex Quattro Birch 5100 SU cumulative dose
Participants receive a cumulative dose regimen of Pollinex Quattro Birch totaling 5100 SU.
Pollinex Quattro Birch 13600 SU cumulative dose
Participants receive a high cumulative dose regimen of Pollinex Quattro Birch totaling 13600 SU.
03
Who it enrols
Adults 18–60 years with seasonal allergic rhinoconjunctivitis due to birch pollen; patients with any acute, chronic, or infectious ocular disorder other than allergic conjunctivitis are excluded.
04
Endpoints
Primary
Change from baseline to post-treatment in total symptom score following conjunctival provocation test
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