RhinitisPhase 2/3NCT02795273
Efficacy and Safety of Grass-SPIRE Registration Study
A Phase 2/3 study testing Grass-SPIRE in people with Rhinitis and Conjunctivitis, run by Circassia Limited at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Rhinitis, Conjunctivitis
- What is being tested?
- Grass-SPIRE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to Oct 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Canton, Ohio
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
About this study
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
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
- Conditions
- Rhinitis, Conjunctivitis
- Being tested
- Grass-SPIRE, Placebo
- Keywords
- Rhinitis, Conjunctivitis, Grass, Allergy
- Medical subject headings
- Rhinitis, Conjunctivitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass-SPIREDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Grass-SPIRE | Experimental | Eight intradermal injections of Grass-SPIRE Receives: Drug: Grass-SPIRE |
| Placebo | Placebo comparator | Eight intradermal injections of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Score of symptoms and allergy medication
Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
Measured: Approximately 66 weeks
Safety of Grass-SPIRE
Measurement of adverse events
Measured: Approximately 66 weeks
Secondary outcomes (3)
Symptom Scores
Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects
Measured: Approximately 66 weeks
Rescue Medication Use
Use of allergy medication to help allergy symptoms
Measured: Approximately 66 weeks
Quality of Life
Assessment of Quality of Life measured by responses to a questionnaire
Measured: Approximately 66 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2018 (estimated)
Why it stopped: Decision made to stop study following availability of results from another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bernstein, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795273
- Sponsor's protocol ID
- TG005
- Status last verified
- Jun 2016
- First submitted
- 5 May 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02795273
- Acronym / sponsor ID
- TG005
- Conditions
- Rhinitis, Conjunctivitis
- Keywords
- Rhinitis, Conjunctivitis, Grass, Allergy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision made to stop study following availability of results from another study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Oct 2018 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grass-SPIRE | Experimental | Drug: Grass-SPIREEight intradermal injections of Grass-SPIRE |
| Placebo | Placebo comparator | Drug: PlaceboEight intradermal injections of Placebo |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grass-SPIRE | Drug | Grass-SPIRE |
| Placebo | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Symptom Scores
Time frame: Approximately 66 weeks
Rescue Medication Use
Time frame: Approximately 66 weeks
Quality of Life
Time frame: Approximately 66 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bernstein, MD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Grass-SPIRE in people with Rhinitis and Conjunctivitis, run by Circassia Limited at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Score of symptoms and allergy medication (time frame: Approximately 66 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.