Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber

Circassia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Biological: Ragweed-SPIRE; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02061709

TR006

Details and patient eligibility

About

The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen

Enrollment: 280 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 18-65 years.
• Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons.
• Minimum qualifying rhinoconjunctivitis symptom scores
• Ragweed-specific Immunoglobulin E (IgE) > 0.70 kU/L.

Exclusion criteria

• Subjects with a history of ragweed pollen induced asthma
• A history of anaphylaxis to ragweed allergen.
• FEV1 < 80 % of predicted.
• Subjects who cannot tolerate Baseline Challenge in the EEC.
• Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
• History of immunopathological diseases (e.g. multiple sclerosis) that in the opinion of the Investigator or the Sponsor could interfere with the results obtained from the study.
• A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
• A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

280 participants in 4 patient groups, including a placebo group

Ragweed-SPIRE 1

Experimental group

Description:

Ragweed SPIRE regimen 1 given 2 weeks apart

Treatment:

Biological: Ragweed-SPIRE

Ragweed-SPIRE 2

Experimental group

Description:

Ragweed-SPIRE regimen 2 given 2 weeks apart

Treatment:

Biological: Ragweed-SPIRE

Ragweed-SPIRE 3

Experimental group

Description:

Ragweed-SPIRE regimen 3 given 2 weeks apart

Treatment:

Biological: Ragweed-SPIRE

Placebo

Placebo Comparator group

Description:

Placebo given 2 weeks apart

Treatment:

Biological: Placebo