A Novel Biologic Therapy for Perennial Allergic Rhinitis

NCT03360071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-09-04

Study results available
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Summary

This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept study which will evaluate the effect of a preparation of FDA approved allergens (PMA) used as a sub-cutaneously administered immunotherapy for the management of allergic rhinitis (perennial and seasonal).

Conditions

  • Allergic Rhinitis

Interventions

DRUG

Allergen Immunotherapy Extract

Allergen Immunotherapy treatment mixture to be delivered subcutaneously

DRUG

Allergen Immunotherapy Control

Allergen Immunotherapy Control Solution to be delivered subcutaneously

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-19
Primary Completion
2018-06-30
Completion
2018-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03360071 on ClinicalTrials.gov