NCT01564017

Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract

Phase II, Multicenter, Randomized, Double-blind Study, With Subcutaneous Immunotherapy, in Parallel Groups and Placebo-controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Dermatophagoides Pteronyssinus.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Roxall Medicina España S.A · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	Allergovac depot	Depot sterile suspension fpor subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 1: 0.25 SPT
BIOLOGICAL	Allergovac depot	Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 2: 0.5 SPT
BIOLOGICAL	Allergovac depot	Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 3: 1 SPT
BIOLOGICAL	Allergovac depot	depot sterile suspension for subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 4: 2 SPT
BIOLOGICAL	Allergovac depot	Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 5: 4 SPT
BIOLOGICAL	Allergovac depot	Sterile suspension for subcutaneous injection. Same number of administration as the active groups

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-03-27
• Last updated: 2017-05-01

Locations

12 sites across 1 country: Spain