NCT02477917

A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica

A Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Roxall Medicina España S.A · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.

Detailed description

Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas, reaching 41.4% among allergic patients on the Spanish Mediterranean coast. The study has been designed as an open trial which will be conducted in 4 Spanish sites.

Conditions

• Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	Allergovac depot with Parietaria judaica pollen extract	Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-06-23
• Last updated: 2017-05-01

Locations

4 sites across 1 country: Spain