Phase II HDM-SPIRE Safety and Efficacy Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Rhinoconjunctivitis

In brief

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

Key facts

Study ID

NCT02150343

Run by

Circassia Limited

People needed

715

Starts

2014-09-01

Expected to finish

2017-04-13

Last updated by the study team

2018-06-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged 18-65 years.
• Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.
• Mean TRSS ≥10
• Positive skin prick test to Der p and Der f.
• Dep p and Der f specific IgE ≥0.7 kU/L

You may not qualify if…

• Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3 (www.ginasthma.org)or higher treatment
• FEV1 <80% of predicted.
• Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
• Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
• Clinically relevant abnormalities detected on physical examination.
• History of severe drug allergy, severe angioedema or anaphylactic reaction to food.

Where it is running

• Study site — Huntington Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Napa, California, United States
• Study site — Orange, California, United States
• Study site — Redwood City, California, United States
• Study site — Rolling Hills Estates, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Stockbridge, Georgia, United States
• Study site — Normal, Illinois, United States
• Study site — Shiloh, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Owensboro, Kentucky, United States
• Study site — Bangor, Maine, United States
• Study site — Bethesda, Maryland, United States
• Study site — Gaithersburg, Maryland, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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