Efficacy and Safety of Grass-SPIRE Registration Study

Sponsor
Circassia Limited (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02795273
Collaborator
(none)
0
2
2
0

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Combined Score of symptoms and allergy medication [Approximately 66 weeks]

    Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication

  2. Safety of Grass-SPIRE [Approximately 66 weeks]

    Measurement of adverse events

Secondary Outcome Measures

  1. Symptom Scores [Approximately 66 weeks]

    Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects

  2. Rescue Medication Use [Approximately 66 weeks]

    Use of allergy medication to help allergy symptoms

  3. Quality of Life [Approximately 66 weeks]

    Assessment of Quality of Life measured by responses to a questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Canton Ohio United States
2 Bernstein Clinical Research Center, LLC Cincinnati Ohio United States 45231

Sponsors and Collaborators

  • Circassia Limited

Investigators

  • Principal Investigator: David Bernstein, MD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Circassia Limited
ClinicalTrials.gov Identifier:
NCT02795273
Other Study ID Numbers:
  • TG005
First Posted:
Jun 10, 2016
Last Update Posted:
Jun 23, 2016
Last Verified:
Jun 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Circassia Limited
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2016