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Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients

NCT03094845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-03-29

No results posted yet for this study

Summary

hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.

Conditions

  • House Dust Mite Allergy

Interventions

BIOLOGICAL

Placebo solution

15 injections over 7 weeks

BIOLOGICAL

hdmASIT+TM

15 injections over 7 weeks

Sponsors & Collaborators

  • ASIT Biotech S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-09-28
Primary Completion
2017-01-12
Completion
2017-01-23

Countries

  • Germany

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 NCT03094845 on ClinicalTrials.gov