Seasonal Allergic RhinitisPhase 2NCT02061709
Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber
A Phase 2 study testing Ragweed-SPIRE in people with Seasonal Allergic Rhinitis, run by Circassia Limited at 5 sites in Canada.
Trial summary
The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Ragweed-SPIRE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2014to Oct 2014
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-65 years.
- Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons.
- Minimum qualifying rhinoconjunctivitis symptom scores
- Ragweed-specific Immunoglobulin E (IgE) > 0.70 kU/L.
Who cannot join
- Subjects with a history of ragweed pollen induced asthma
- A history of anaphylaxis to ragweed allergen.
- FEV1 < 80 % of predicted.
- Subjects who cannot tolerate Baseline Challenge in the EEC.
- Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- History of immunopathological diseases (e.g. multiple sclerosis) that in the opinion of the Investigator or the Sponsor could interfere with the results obtained from the study.
- A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
- A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Kanata Allergy Services
Kanata, Ontario, K2L 3C8
KGK Synergize Inc
London, Ontario, N6A 5R8
Inflamax Research
Mississauga, Ontario, L8P 0A1
Taunton Health Centre
Oshawa, Ontario, L1H 7K4
Windsor Allergy Asthma Associates
Windsor, Ontario, N8X 2G1
About this study
Official title: A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate Three Dose Regimens of Ragweed-SPIRE in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber
The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Ragweed-SPIRE, Placebo
- Keywords
- Rhinoconjunctivitis, Rhinitis, Seasonal, Ragweed, Allergy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ragweed-SPIREBiological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Ragweed-SPIRE 1 | Experimental | Ragweed SPIRE regimen 1 given 2 weeks apart Receives: Biological: Ragweed-SPIRE |
| Ragweed-SPIRE 2 | Experimental | Ragweed-SPIRE regimen 2 given 2 weeks apart Receives: Biological: Ragweed-SPIRE |
| Ragweed-SPIRE 3 | Experimental | Ragweed-SPIRE regimen 3 given 2 weeks apart Receives: Biological: Ragweed-SPIRE |
| Placebo | Placebo comparator | Placebo given 2 weeks apart Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)
Measured: Between Baseline and approximately 25 weeks after randomisation
Secondary outcomes (4)
Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints
Measured: Between Baseline and approximately 25 weeks after randomisation
Change from Baseline in mean Total Nasal Symptom Score (TNSS)
Measured: Aproximately 25 weeks after randomisation
Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)
Measured: Approximately 25 weeks after randomisation
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Measured: Approximately 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Piyush Patel, MD, Principal investigator, Inflamax Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061709
- Sponsor's protocol ID
- TR006
- Status last verified
- Mar 2015
- First submitted
- 3 Feb 2014
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate Three Dose Regimens of Ragweed-SPIRE in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT02061709
- Acronym / sponsor ID
- TR006
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Rhinoconjunctivitis, Rhinitis, Seasonal, Ragweed, Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Feb 2014 (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 determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ragweed-SPIRE 1 | Experimental | Biological: Ragweed-SPIRERagweed SPIRE regimen 1 given 2 weeks apart |
| Ragweed-SPIRE 2 | Experimental | Biological: Ragweed-SPIRERagweed-SPIRE regimen 2 given 2 weeks apart |
| Ragweed-SPIRE 3 | Experimental | Biological: Ragweed-SPIRERagweed-SPIRE regimen 3 given 2 weeks apart |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo given 2 weeks apart |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18-65 years.
- Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons.
- Minimum qualifying rhinoconjunctivitis symptom scores
- Ragweed-specific Immunoglobulin E (IgE) > 0.70 kU/L.
Key exclusion criteria (8 listed)
- Subjects with a history of ragweed pollen induced asthma
- A history of anaphylaxis to ragweed allergen.
- FEV1 < 80 % of predicted.
- Subjects who cannot tolerate Baseline Challenge in the EEC.
- Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
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 |
|---|---|---|
| Ragweed-SPIRE | Biological | Ragweed-SPIRE 1, Ragweed-SPIRE 2, Ragweed-SPIRE 3 |
| Placebo | Biological | Placebo |
Primary outcome
Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)
Time frame: Between Baseline and approximately 25 weeks after randomisation
4 secondary outcomes
Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints
Time frame: Between Baseline and approximately 25 weeks after randomisation
Change from Baseline in mean Total Nasal Symptom Score (TNSS)
Time frame: Aproximately 25 weeks after randomisation
Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)
Time frame: Approximately 25 weeks after randomisation
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time frame: Approximately 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
Related trials for Seasonal Allergic Rhinitis
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
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.
Piyush Patel, MD principal investigator
Inflamax Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ragweed-SPIRE in people with Seasonal Allergic Rhinitis, run by Circassia Limited at 5 sites in Canada.
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 8 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: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) (time frame: Between Baseline and approximately 25 weeks after randomisation). 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 20 Mar 2015.