Phase II HDM-SPIRE Safety and Efficacy Study

Circassia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Rhinoconjunctivitis

Treatments: Drug: HDM-SPIRE; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02150343

TH005

Details and patient eligibility

About

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

Enrollment: 715 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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715 participants in 4 patient groups, including a placebo group

HMD-SPIRE Treatment 1

Experimental group

Description:

4 x 12 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart

Treatment:

Drug: HDM-SPIRE

Drug: Placebo

HDM-SPIRE Treatment 2

Experimental group

Description:

4 x 12 nmol HDM-SPIRE 4 weeks apart followed by a second course of 4 x 12 nmol HDM-SPIRE 4 weeks apart

Treatment:

Drug: HDM-SPIRE

HDM-SPIRE Treatment 3

Experimental group

Description:

4 x 20 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart

Treatment:

Drug: HDM-SPIRE

Drug: Placebo

Placebo

Placebo Comparator group

Description:

8 x placebo 4 weeks apart

Treatment:

Drug: Placebo