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Efficacy and Safety of Grass-SPIRE Registration Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795273
Recruitment Status : Withdrawn (Decision made to stop study following availability of results from another study)
First Posted : June 10, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Circassia Limited

Tracking Information
First Submitted Date  ICMJE May 5, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Combined Score of symptoms and allergy medication [ Time Frame: Approximately 66 weeks ]
    Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
  • Safety of Grass-SPIRE [ Time Frame: Approximately 66 weeks ]
    Measurement of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Symptom Scores [ Time Frame: Approximately 66 weeks ]
    Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects
  • Rescue Medication Use [ Time Frame: Approximately 66 weeks ]
    Use of allergy medication to help allergy symptoms
  • Quality of Life [ Time Frame: Approximately 66 weeks ]
    Assessment of Quality of Life measured by responses to a questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Grass-SPIRE Registration Study
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rhinitis
  • Conjunctivitis
Intervention  ICMJE
  • Drug: Grass-SPIRE
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Grass-SPIRE
    Eight intradermal injections of Grass-SPIRE
    Intervention: Drug: Grass-SPIRE
  • Placebo Comparator: Placebo
    Eight intradermal injections of Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 21, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
1500
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795273
Other Study ID Numbers  ICMJE TG005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Circassia Limited
Study Sponsor  ICMJE Circassia Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Bernstein, MD University of Cincinnati
PRS Account Circassia Limited
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP