Ragweed AllergyPhase 2NCT01361412
Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy
A Phase 2 study testing ToleroMune Ragweed in people with Ragweed Allergy, run by Circassia Limited at 1 site in Canada.
Trial summary
The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy. 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
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Sep 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
- Enrolled in study TR002 but have not yet commenced dosing
Who cannot join
- None; no criteria additional to TR002 exclusion criteria are applicable to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Optional Research Study to Identify Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy in Subjects Already Enrolled in Clinical Study TR002
The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.
- Conditions
- Ragweed Allergy
- Being tested
- ToleroMune Ragweed, Placebo
- Keywords
- ragweed allergy, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToleroMune RagweedBiological
Intradermal administration 1x8 administrations, 2 weeks apart
PlaceboBiological
Intradermal injection 1x8 administrations, 2 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| ToleroMune Ragweed 4 | Experimental | Not described Receives: Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 3 | Experimental | Not described Receives: Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 2 | Experimental | Not described Receives: Biological: ToleroMune Ragweed |
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo |
| ToleroMune Ragweed Regimen 1 | Experimental | Not described Receives: Biological: ToleroMune Ragweed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of potential plasma biomarkers of response to peptide immunotherapy
Blood samples derived from the study will be submitted for proteomics analyses aimed at the identification of one or more plasma proteins whose concentration over the course of the study varies in relation to the treatment administered. The outcome will be determined on the basis of measurements from samples collected over a period commencing prior to treatment and ending 6 months following treatmen
Measured: 6 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 posted26 May 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionSep 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT01361412
- Sponsor's protocol ID
- TR002A
- Status last verified
- Oct 2011
- First submitted
- 24 May 2011
- Last updated
- 7 Oct 2011
- Results posted
- 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
- An Optional Research Study to Identify Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy in Subjects Already Enrolled in Clinical Study TR002
- ClinicalTrials.gov ID
- NCT01361412
- Acronym / sponsor ID
- TR002A
- Conditions
- Ragweed Allergy
- Keywords
- ragweed allergy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Cetero Research, San Antonio
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 May 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.
The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ToleroMune Ragweed 4 | Experimental | Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 3 | Experimental | Biological: ToleroMune Ragweed |
| ToleroMune Ragweed Regimen 2 | Experimental | Biological: ToleroMune Ragweed |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo |
| ToleroMune Ragweed Regimen 1 | 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 (1 listed)
- Enrolled in study TR002 but have not yet commenced dosing
Key exclusion criteria (1 listed)
- None; no criteria additional to TR002 exclusion criteria are applicable to this 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 |
|---|---|---|
| ToleroMune RagweedIntradermal administration 1x8 administrations, 2 weeks apart | Biological | ToleroMune Ragweed 4, ToleroMune Ragweed Regimen 1, ToleroMune Ragweed Regimen 2, ToleroMune Ragweed Regimen 3 |
| PlaceboIntradermal injection 1x8 administrations, 2 weeks apart | Biological | Placebo |
Primary outcome
Identification of potential plasma biomarkers of response to peptide immunotherapy
Time frame: 6 months after start of dosing
Blood samples derived from the study will be submitted for proteomics analyses aimed at the identification of one or more plasma proteins whose concentration over the course of the study varies in relation to the treatment administered. The outcome will be determined on the basis of measurements from samples collected over a period commencing prior to treatment and ending 6 months following treatmen
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
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 ToleroMune Ragweed in people with Ragweed Allergy, 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 1 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 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. 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?
Identification of potential plasma biomarkers of response to peptide immunotherapy (time frame: 6 months 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 7 Oct 2011.