Birch-SPIRE Safety and Efficacy Study

Circassia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Rhinitis

Treatments: Biological: Placebo; Biological: Birch-SPIRE

Study type: Interventional

Funder types: Industry

Identifiers

NCT02478060

CB001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 18 to 65 years;
• Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
• Birch IgE ≥ 0.35 kU/L
• Positive skin prick test to whole birch allergen

Exclusion criteria

• Any past history of asthma
• FEV1 < 80% of predicted
• History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
• Acute phase skin response to whole birch allergen with a mean wheal diameter > 50mm
• Administration of adrenaline (epinephrine) is contraindicated
• History of severe drug allergy or anaphylactic reaction to food.
• History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Birch-SPIRE or placebo, 2 weeks apart

Treatment:

Biological: Placebo

Biological: Birch-SPIRE

Cohort 2

Experimental group

Description:

Birch-SPIRE or placebo, 2 weeks apart

Treatment:

Biological: Placebo

Biological: Birch-SPIRE

Cohort 3

Experimental group

Description:

Birch-SPIRE or placebo, 2 weeks apart

Treatment:

Biological: Placebo

Biological: Birch-SPIRE

Cohort 4

Experimental group

Description:

Birch-SPIRE or placebo, 2 weeks apart

Treatment:

Biological: Placebo

Biological: Birch-SPIRE

Cohort 5

Experimental group

Description:

Birch-SPIRE or placebo, 2 weeks apart

Treatment:

Biological: Placebo

Biological: Birch-SPIRE