Grass AllergyPhase 2NCT01385800
ToleroMune Grass Exposure Unit Study
A Phase 2 study testing ToleroMune Grass in people with Grass Allergy and Rhinoconjunctivitis, run by Circassia Limited at 1 site in Canada.
Trial summary
Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Grass Allergy, Rhinoconjunctivitis
- What is being tested?
- ToleroMune Grass
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Aug 2013
- 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 grass.
- Positive skin prick test to grass allergen.
- Minimum qualifying rhinoconjunctivitis symptom scores
Who cannot join
- History of asthma.
- A history of anaphylaxis to grassallergen.
- Subjects with an FEV1 <80% of predicted.
- Subjects who cannot tolerate baseline challenge in the EEU.
- 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
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate Three Doses of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit
Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.
This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU).
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 Grass in grass allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Grass will be explored in subjects using an EEU (Environmental Exposure Unit).
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 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 EEU 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 four 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 EEU about 25 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
- Grass Allergy, Rhinoconjunctivitis
- Being tested
- ToleroMune Grass, Placebo
- Keywords
- Grass allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune Grass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToleroMune GrassBiological
Intradermal injection 1 x 8 administrations 2 weeks apart
PlaceboBiological
Intradermal injection 1 x 8 administrations 2 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intradermal injection, 1 x 8 administrations 2 weeks apart Receives: Biological: Placebo |
| ToleroMune Grass Dose 1 | Experimental | Intradermal injection 1 x 8 administrations 2 weeks apart Receives: Biological: ToleroMune Grass |
| ToleroMune Grass Dose 2 | Experimental | Intradermal injection 1 x 8 administrations 2 weeks apart Receives: Biological: ToleroMune Grass |
| ToleroMune Grass Dose 3 | Experimental | Intradermal injection 1 x 8 administrations 2 weeks apart Receives: Biological: ToleroMune Grass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Rhinoconjunctivitis Symptom Score
Measured: Upto 25 weeks
Secondary outcomes (7)
Symptom scores for nasal and non nasal symptoms
Measured: Upto 25 weeks
Skin prick testing
Measured: Upto 25 weeks
Peak Nasal Inspiratory Flow
Measured: Up to 25 weeks
Grass specific IgA
Measured: Upto 26 weeks
Grass specific IgE
Measured: Upto 26 weeks
Grass specific IgG4
Measured: Up to 26 weeks
Adverse Events
Measured: Up tp 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grass 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Pharm-Olam International
- Responsible party
- Sponsor
- Investigators
- Anne K Ellis, MD MSC FRCPC, Principal investigator, Queen's University, Kingston, Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385800
- Sponsor's protocol ID
- TG002
- Status last verified
- Aug 2013
- First submitted
- 29 Jun 2011
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. 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 Doses of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit
- ClinicalTrials.gov ID
- NCT01385800
- Acronym / sponsor ID
- TG002
- Conditions
- Grass Allergy, Rhinoconjunctivitis
- Keywords
- Grass allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune Grass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Pharm-Olam International
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Jun 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.
Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.
This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU).
Detailed description
This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Grass will be explored in subjects using an EEU (Environmental Exposure Unit).
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 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 EEU 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 four 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 EEU about 25 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboIntradermal injection, 1 x 8 administrations 2 weeks apart |
| ToleroMune Grass Dose 1 | Experimental | Biological: ToleroMune GrassIntradermal injection 1 x 8 administrations 2 weeks apart |
| ToleroMune Grass Dose 2 | Experimental | Biological: ToleroMune GrassIntradermal injection 1 x 8 administrations 2 weeks apart |
| ToleroMune Grass Dose 3 | Experimental | Biological: ToleroMune GrassIntradermal injection 1 x 8 administrations 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.
- Minimum 2-year documented history of rhinoconjunctivitis on exposure to grass.
- Positive skin prick test to grass allergen.
- Minimum qualifying rhinoconjunctivitis symptom scores
Key exclusion criteria (7 listed)
- History of asthma.
- A history of anaphylaxis to grassallergen.
- Subjects with an FEV1 <80% of predicted.
- Subjects who cannot tolerate baseline challenge in the EEU.
- 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 GrassIntradermal injection 1 x 8 administrations 2 weeks apart | Biological | ToleroMune Grass Dose 1, ToleroMune Grass Dose 2, ToleroMune Grass Dose 3 |
| PlaceboIntradermal injection 1 x 8 administrations 2 weeks apart | Biological | Placebo |
Primary outcome
Total Rhinoconjunctivitis Symptom Score
Time frame: Upto 25 weeks
7 secondary outcomes
Symptom scores for nasal and non nasal symptoms
Time frame: Upto 25 weeks
Skin prick testing
Time frame: Upto 25 weeks
Peak Nasal Inspiratory Flow
Time frame: Up to 25 weeks
Grass specific IgA
Time frame: Upto 26 weeks
Grass specific IgE
Time frame: Upto 26 weeks
Grass specific IgG4
Time frame: Up to 26 weeks
Adverse Events
Time frame: Up tp 26 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 15 Aug 2013.
Related trials for Grass Allergy
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RecruitingObservational study
GRASS (Grass MATA MPL Real-world Assessment Study)
Grass Pollen Allergy
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.
Anne K Ellis, MD MSC FRCPC principal investigator
Queen's University, Kingston, Ontario
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 Grass in people with Grass 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 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 15 Aug 2013. 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?
Total Rhinoconjunctivitis Symptom Score (time frame: Upto 25 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 15 Aug 2013; AzTrials last refreshed its copy on 27 Oct 2026.