Efficacy and Safety of Grass-SPIRE Registration Study

A Combined Phase 2b/3, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study to Assess the Efficacy and Safety of Grass-SPIRE in Subjects With Grass Pollen-Induced Allergic Rhinitis, With or Without Conjunctivitis

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

Study Overview

• Status: Withdrawn
• Conditions: Rhinitis; Conjunctivitis
• Intervention / Treatment: Drug: Placebo; Drug: Grass-SPIRE

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canton, Ohio, United States
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grass-SPIRE; Eight intradermal injections of Grass-SPIRE	Drug: Grass-SPIRE
Placebo Comparator: Placebo; Eight intradermal injections of Placebo	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined Score of symptoms and allergy medication	Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication	Approximately 66 weeks
Safety of Grass-SPIRE	Measurement of adverse events	Approximately 66 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Scores	Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects	Approximately 66 weeks
Rescue Medication Use	Use of allergy medication to help allergy symptoms	Approximately 66 weeks
Quality of Life	Assessment of Quality of Life measured by responses to a questionnaire	Approximately 66 weeks

Collaborators and Investigators

• Sponsor: Circassia Limited
• Investigators: Principal Investigator: David Bernstein, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: May 5, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Estimate): June 23, 2016
• Last Update Submitted That Met QC Criteria: June 21, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Allergy; Conjunctivitis; Rhinitis; Grass
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Eye Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Conjunctival Diseases; Rhinitis; Conjunctivitis
• Other Study ID Numbers: TG005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided