Efficacy and Safety of Grass-SPIRE Registration Study

Circassia Pharmaceuticals

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Conjunctivitis; Rhinitis

Treatments: Drug: Grass-SPIRE; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02795273

TG005

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years
• Score of ≤ 21 on RCAT questionnaire
• Rye grass specific IgE of ≥ 0.7 kU/L
• Positive skin prick test to Rye grass whole allergen extract

Exclusion criteria

• History or findings of significant disease
• Asthma requiring GINA Step 3 or higher treatment
• History of severe drug allergy, severe angioedema or systemic allergic reaction
• Course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years
• Contraindications for administration of epinephrine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Grass-SPIRE

Experimental group

Description:

Eight intradermal injections of Grass-SPIRE

Treatment:

Drug: Grass-SPIRE

Placebo

Placebo Comparator group

Description:

Eight intradermal injections of Placebo

Treatment:

Drug: Placebo