RhinitisPhase 2NCT02478060
Birch-SPIRE Safety and Efficacy Study
A Phase 2 study testing Birch-SPIRE in people with Rhinitis, run by Circassia Limited at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis
- What is being tested?
- Birch-SPIRE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jul 2016
- 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 to 65 years;
- Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
- Birch IgE ≥ 0.35 kU/L
- Positive skin prick test to whole birch allergen
Who cannot join
- Any past history of asthma
- FEV1 < 80% of predicted
- History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
- Acute phase skin response to whole birch allergen with a mean wheal diameter > 50mm
- Administration of adrenaline (epinephrine) is contraindicated
- History of severe drug allergy or anaphylactic reaction to food.
- History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche Appliqué en Allergie de Québec
Québec, Quebec, G1V 4M6
About this study
Official title: A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.
- Conditions
- Rhinitis
- Being tested
- Birch-SPIRE, Placebo
- Keywords
- Allergy, Birch, Rhinitis, Rhinoconjuntivitis, SPIRE, Toleromune
- Medical subject headings
- Rhinitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birch-SPIREBiological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Birch-SPIRE or placebo, 2 weeks apart Receives: Biological: Birch-SPIRE; Biological: Placebo |
| Cohort 2 | Experimental | Birch-SPIRE or placebo, 2 weeks apart Receives: Biological: Birch-SPIRE; Biological: Placebo |
| Cohort 3 | Experimental | Birch-SPIRE or placebo, 2 weeks apart Receives: Biological: Birch-SPIRE; Biological: Placebo |
| Cohort 4 | Experimental | Birch-SPIRE or placebo, 2 weeks apart Receives: Biological: Birch-SPIRE; Biological: Placebo |
| Cohort 5 | Experimental | Birch-SPIRE or placebo, 2 weeks apart Receives: Biological: Birch-SPIRE; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Birch-SPIRE administrations measured by Adverse Events
Measured: Up to 16 weeks after start of dosing
Secondary outcomes (3)
Measurement of IgE as a Pharmacodynamic parameter
Measured: Up to 9 months after start of dosing
Conjunctival Provocation Test as a Pharmacodynamic parameter
Measured: Up to 9 months after start of dosing
Skin Prick Testing as a Pharmacodynamic parameter
Measured: Up to 9 months after start of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478060
- Sponsor's protocol ID
- CB001
- Status last verified
- Nov 2016
- First submitted
- 11 Jun 2015
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
- ClinicalTrials.gov ID
- NCT02478060
- Acronym / sponsor ID
- CB001
- Conditions
- Rhinitis
- Keywords
- Allergy, Birch, Rhinitis, Rhinoconjuntivitis, SPIRE, Toleromune
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Quintiles, Inc.
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- First posted
- 23 Jun 2015 (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 and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Birch-SPIRE, Biological: PlaceboBirch-SPIRE or placebo, 2 weeks apart |
| Cohort 2 | Experimental | Biological: Birch-SPIRE, Biological: PlaceboBirch-SPIRE or placebo, 2 weeks apart |
| Cohort 3 | Experimental | Biological: Birch-SPIRE, Biological: PlaceboBirch-SPIRE or placebo, 2 weeks apart |
| Cohort 4 | Experimental | Biological: Birch-SPIRE, Biological: PlaceboBirch-SPIRE or placebo, 2 weeks apart |
| Cohort 5 | Experimental | Biological: Birch-SPIRE, Biological: PlaceboBirch-SPIRE or placebo, 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 to 65 years;
- Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
- Birch IgE ≥ 0.35 kU/L
- Positive skin prick test to whole birch allergen
Key exclusion criteria (7 listed)
- Any past history of asthma
- FEV1 < 80% of predicted
- History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
- Acute phase skin response to whole birch allergen with a mean wheal diameter > 50mm
- Administration of adrenaline (epinephrine) is contraindicated
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 |
|---|---|---|
| Birch-SPIRE | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| Placebo | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Safety of Birch-SPIRE administrations measured by Adverse Events
Time frame: Up to 16 weeks after start of dosing
3 secondary outcomes
Measurement of IgE as a Pharmacodynamic parameter
Time frame: Up to 9 months after start of dosing
Conjunctival Provocation Test as a Pharmacodynamic parameter
Time frame: Up to 9 months after start of dosing
Skin Prick Testing as a Pharmacodynamic parameter
Time frame: Up to 9 months after start of dosing
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 8 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Birch-SPIRE in people with Rhinitis, run by Circassia Limited at 1 site 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 7 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Safety of Birch-SPIRE administrations measured by Adverse Events (time frame: Up to 16 weeks after start of dosing). 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 8 Nov 2016.