NCT02795273

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

2.4 years

First QC Date

May 5, 2016

Last Update Submit

June 21, 2016

Conditions

RhinitisConjunctivitis

Keywords

RhinitisConjunctivitisGrassAllergy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Symptom Scores

    Approximately 66 weeks

  • Rescue Medication Use

    Approximately 66 weeks

  • Quality of Life

    Approximately 66 weeks

Study Arms (2)

Grass-SPIRE

EXPERIMENTAL

Eight intradermal injections of Grass-SPIRE

Drug: Grass-SPIRE

Placebo

PLACEBO COMPARATOR

Eight intradermal injections of Placebo

Drug: Placebo

Interventions

Grass-SPIREDRUG
Grass-SPIRE
PlaceboDRUG
Placebo

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Canton, Ohio, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231, United States

Location

MeSH Terms

Conditions

RhinitisConjunctivitisHypersensitivity

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesConjunctival DiseasesEye DiseasesImmune System Diseases

Study Officials

  • David Bernstein, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2016

First Posted

June 10, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2018

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

US(2)