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Safety of hdmASIT+TM in House Dust Mite Allergy
NCT03094845Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2016
- Primary completion
- Jan 2017
- Countries
- 1
- Sponsor
- ASIT Biotech
- Modality
- Peptides, Vaccines & Immunotherapeutics
- Drugs
- hdm-ASIT+
- Conditions
- allergic rhinoconjunctivitis (ARC)
01
Overview
Phase 2, randomised, double-blind trial in allergic rhinoconjunctivitis (ARC) comparing hdmASIT+TM with Placebo (2 arms). Primary endpoint: Solicited adverse events at 7 weeks. Started Sep 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
hdmASIT+TM
hdmASIT+TM subcutaneous injections
Placebo
Placebo solution subcutaneous injections
03
Who it enrols
Patients with moderate to severe house dust mite-induced allergic rhinoconjunctivitis, positive skin prick test, and specific IgE. Asthmatic patients must be controlled.
04
Endpoints
Primary
Solicited adverse events
Secondary
Unsolicited adverse events and serious adverse events (SAEs)
Physical examinations and vital signs
Laboratory investigations
Pulmonary functions (FEV1)
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