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Phase II HDM-SPIRE Safety and Efficacy Study

NCT02150343 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 715

Last updated 2018-06-15

Study results available
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Summary

The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality

Conditions

  • Rhinoconjunctivitis

Interventions

DRUG

HDM-SPIRE

1 dose every 4 weeks

DRUG

Placebo

1 dose every 4 weeks

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Circassia Limited

    lead INDUSTRY

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
2014-09-30
Primary Completion
2017-04-13
Completion
2017-04-13

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02150343 on ClinicalTrials.gov