Ragweed AllergyNCT01448603
ToleroMune Ragweed Follow up Study
An observational study of Ragweed Allergy and Rhinoconjunctivitis, run by Circassia Limited at 1 site in Canada.
Trial summary
Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2% The purpose of this observational… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ragweed Allergy, Rhinoconjunctivitis
- What is being tested?
- ToleroMune Ragweed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Mar 2012
- Phase
- Observational
- 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
Study population: Subjects previously randomised in study TR002 and completed all dosing visits and the Post Treatment Challenge (PTC).
Who may be able to join
- Previously randomised into study TR002 and completed all treatment visits and the PTC.
Who cannot join
- History of asthma (a diagnosis of asthma in childhood may be allowed).
- Subjects with an FEV1 <70% of predicted.
- Subjects being treated with beta-blockers.
- Developed a significant disease, disorder or inability to communicate, since completing study TR002 which, in the opinion of the Sponsor's medical representative, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.
Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2%
The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing visits and the post treatment challenge (PTC) visit in study TR002 approximately one year after the start of treatment.
Read the detailed description
Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4 visits on successive days. Following the final EEC visit a follow-up visit will be performed 3-10 days later.
- Conditions
- Ragweed Allergy, Rhinoconjunctivitis
- Being tested
- Placebo, ToleroMune Ragweed
- Keywords
- Ragweed allergy, ToleroMune ragweed, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune RagweedBiological
No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Subjects previously randomised to placebo in TR002 Receives: Biological: Placebo | |
| ToleroMune Ragweed Regimen 1 | Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002 Receives: Biological: ToleroMune Ragweed | |
| ToleroMune Ragweed Regimen 2 | Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002 Receives: Biological: ToleroMune Ragweed | |
| ToleroMune Ragweed regimen 3 | Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002 Receives: Biological: ToleroMune Ragweed | |
| ToleroMune Ragweed regimen 4 | Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002 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: 48-54 weeks after the start of treatment in TR002
Secondary outcomes (5)
Total nasal and non-nasal symptom scores
Measured: 48-54 weeks after the start of treatment in TR002
Change in Immunoglobulin A (IgA)
Measured: 50-56 weeks after the start of treatment in Tr002
Change in Immunoglobulin E (IgE)
Measured: 50-56 weeks after the start of treatment in Tr002
Change in Immunoglobulin G4 (IgG4)
Measured: 50-56 weeks after the start of treatment in Tr002
Adverse Events
Measured: 50-56 weeks after the start of treatment in TR002
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 2012
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
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
- Peter Couroux, MD, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448603
- Sponsor's protocol ID
- TR002B
- Status last verified
- May 2012
- First submitted
- 6 Oct 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.
- ClinicalTrials.gov ID
- NCT01448603
- Acronym / sponsor ID
- TR002B
- Conditions
- Ragweed Allergy, Rhinoconjunctivitis
- Keywords
- Ragweed allergy, ToleroMune ragweed, immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Cetero Research, San Antonio
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Oct 2011 (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.
Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2%
The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing visits and the post treatment challenge (PTC) visit in study TR002 approximately one year after the start of treatment.
Detailed description
Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4 visits on successive days. Following the final EEC visit a follow-up visit will be performed 3-10 days later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | Biological: PlaceboSubjects previously randomised to placebo in TR002 |
| ToleroMune Ragweed Regimen 1 | – | Biological: ToleroMune RagweedSubjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002 |
| ToleroMune Ragweed Regimen 2 | – | Biological: ToleroMune RagweedSubject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002 |
| ToleroMune Ragweed regimen 3 | – | Biological: ToleroMune RagweedSubject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002 |
| ToleroMune Ragweed regimen 4 | – | Biological: ToleroMune RagweedSubjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects previously randomised in study TR002 and completed all dosing visits and the Post Treatment Challenge (PTC).
Key inclusion criteria (1 listed)
- Previously randomised into study TR002 and completed all treatment visits and the PTC.
Key exclusion criteria (4 listed)
- History of asthma (a diagnosis of asthma in childhood may be allowed).
- Subjects with an FEV1 <70% of predicted.
- Subjects being treated with beta-blockers.
- Developed a significant disease, disorder or inability to communicate, since completing study TR002 which, in the opinion of the Sponsor's medical representative, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.
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 |
|---|---|---|
| PlaceboNo further medication to be administered in this study. Intervention refers to treatment received in Study TR002. | Biological | Placebo |
| ToleroMune RagweedNo further medication to be administered in this study. Intervention refers to treatment received in Study TR002. | Biological | ToleroMune Ragweed Regimen 1, ToleroMune Ragweed Regimen 2, ToleroMune Ragweed regimen 3, ToleroMune Ragweed regimen 4 |
Primary outcome
Total Rhinoconjunctivitis Symptom Score
Time frame: 48-54 weeks after the start of treatment in TR002
5 secondary outcomes
Total nasal and non-nasal symptom scores
Time frame: 48-54 weeks after the start of treatment in TR002
Change in Immunoglobulin A (IgA)
Time frame: 50-56 weeks after the start of treatment in Tr002
Change in Immunoglobulin E (IgE)
Time frame: 50-56 weeks after the start of treatment in Tr002
Change in Immunoglobulin G4 (IgG4)
Time frame: 50-56 weeks after the start of treatment in Tr002
Adverse Events
Time frame: 50-56 weeks after the start of treatment in TR002
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 17 May 2012.
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.
Peter Couroux, MD principal investigator
Cetero Research, San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ragweed Allergy and Rhinoconjunctivitis, 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 1 inclusion and 4 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 17 May 2012. 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.
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: 48-54 weeks after the start of treatment in TR002). 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 17 May 2012.