Ragweed AllergyPhase 2NCT01198613
ToleroMune Ragweed Exposure Chamber Study
A Phase 2 study testing ToleroMune Ragweed in people with Ragweed Allergy, run by Circassia Limited at 2 sites in Canada.
Trial summary
It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ragweed Allergy
- What is being tested?
- ToleroMune Ragweed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2010to Aug 2011
- 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.
- Minimum 2-year documented history of rhinoconjunctivitis on exposure to ragweed. [Subjects may also have controlled asthma
- Positive skin prick test to ragweed allergen.
- Minimum qualifying rhinoconjunctivitis symptom scores
Who cannot join
- History of asthma.
- A history of anaphylaxis to ragweed allergen.
- Subjects with an FEV1 <70% of predicted.
- Subjects who cannot tolerate baseline challenge in the EEC.
- Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- 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
2 sites in 1 country.
Canada2 sites
KGK Synergize Inc.
London, Ontario, ON N6A 5R8
Cetero Research
Mississauga, Ontario, L4W 1N2
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate Two Doses of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber
It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy.
This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.
Read the detailed description
This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.
In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of five groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.
In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.
- Conditions
- Ragweed Allergy
- Being tested
- ToleroMune Ragweed, Placebo
- Keywords
- Ragweed allergy, Rhinoconjunctivitis, Exposure chamber, Immunotherapy, ToleroMune Ragweed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToleroMune RagweedBiological
Intradermal injection 1 x8 administrations 2 weeks apart
PlaceboBiological
Intradermal injection, 1x8 administrations 2 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| ToleroMune Ragweed Regimen 1 | Experimental | Not described Receives: Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 2 | Experimental | Not described Receives: Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 3 | Experimental | Not described Receives: Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 4 | Experimental | Not described Receives: Biological: ToleroMune Ragweed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Rhinoconjunctivitis Symptom Score
Measured: Upto 22 weeks
Secondary outcomes (7)
Symptom scores for ocular and nasal symptoms
Measured: Upto 22 weeks
Acoustic Rhinometry
Measured: Upto 22 weeks
Skin prick testing
Measured: Baseline and final follow up
Ragweed specific IgE
Measured: At baseline and at follow up
Ragweed specific IgA
Measured: At baseline and follow up
Ragweed specific IgG4
Measured: At baseline and at follow up
Adverse Events
Measured: Upto 23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ragweed AllergyStudies 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, Investigator, Outcomes assessor
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Cetero Research, San Antonio
- Responsible party
- Sponsor
- Investigators
- Deepen Patel, MD, CCFP, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198613
- Sponsor's protocol ID
- TR002
- Status last verified
- Oct 2011
- First submitted
- 6 Sep 2010
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled Study to Evaluate Two Doses of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT01198613
- Acronym / sponsor ID
- TR002
- Conditions
- Ragweed Allergy
- Keywords
- Ragweed allergy, Rhinoconjunctivitis, Exposure chamber, Immunotherapy, ToleroMune Ragweed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Cetero Research, San Antonio
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Sep 2010 (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.
It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy.
This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.
Detailed description
This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.
In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of five groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.
In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo |
| ToleroMune Ragweed Regimen 1 | Experimental | Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 2 | Experimental | Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 3 | Experimental | Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 4 | Experimental | Biological: ToleroMune Ragweed |
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.
- Minimum 2-year documented history of rhinoconjunctivitis on exposure to ragweed. [Subjects may also have controlled asthma
- Positive skin prick test to ragweed allergen.
- Minimum qualifying rhinoconjunctivitis symptom scores
Key exclusion criteria (7 listed)
- History of asthma.
- A history of anaphylaxis to ragweed allergen.
- Subjects with an FEV1 <70% of predicted.
- Subjects who cannot tolerate baseline challenge in the EEC.
- Subjects for whom administration of epinephrine is contra-indicated (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 |
|---|---|---|
| ToleroMune RagweedIntradermal injection 1 x8 administrations 2 weeks apart | Biological | ToleroMune Ragweed Regimen 1, ToleroMune Ragweed Regimen 2, ToleroMune Ragweed Regimen 3, ToleroMune Ragweed Regimen 4 |
| PlaceboIntradermal injection, 1x8 administrations 2 weeks apart | Biological | Placebo |
Primary outcome
Total Rhinoconjunctivitis Symptom Score
Time frame: Upto 22 weeks
7 secondary outcomes
Symptom scores for ocular and nasal symptoms
Time frame: Upto 22 weeks
Acoustic Rhinometry
Time frame: Upto 22 weeks
Skin prick testing
Time frame: Baseline and final follow up
Ragweed specific IgE
Time frame: At baseline and at follow up
Ragweed specific IgA
Time frame: At baseline and follow up
Ragweed specific IgG4
Time frame: At baseline and at follow up
Adverse Events
Time frame: Upto 23 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 7 Oct 2011.
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.
Deepen Patel, MD, CCFP principal investigator
Cetero Research, San Antonio
2 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 ToleroMune Ragweed in people with Ragweed Allergy, run by Circassia Limited at 2 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 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 7 Oct 2011. 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 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?
Total Rhinoconjunctivitis Symptom Score (time frame: Upto 22 weeks). 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 7 Oct 2011.