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

NCT02477917 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-05-01

No results posted yet for this study

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.

Conditions

  • Rhinoconjunctivitis

Interventions

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

Sponsors & Collaborators

  • Roxall Medicina España S.A

    lead INDUSTRY

Principal Investigators

  • Araitz Landeta · Roxall Medicina España S.A

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477917 on ClinicalTrials.gov