AllergyPhase 2NCT01166061
Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis
A Phase 2 study testing ToleroMune Grass in people with Allergy, run by Circassia Limited at 1 site in Canada.
Trial summary
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy
- What is being tested?
- ToleroMune Grass
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Apr 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 history of rhinoconjunctivitis on exposure to grass
- Positive skin prick test to whole grass allergen
- LPSR to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
- Positive CPT to whole grass allergen with a score ≥4
Who cannot join
- Subjects with a history of asthma
- Subjects with an FEV1 <80% of predicted
- Subjects with a rye grass specific IgE >100 kU/L
- Subjects with an acute phase skin response to whole grass allergen with a mean wheal diameter > 50 mm
- Subjects who score >1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the CPT
- Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquillisers or psychoactive drugs
- History of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)
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: An Escalating, Multiple-dose Study in Grass Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Grass
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 40% of allergic patients are sensitized 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.
The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Grass in subjects allergic to grass.
Read the detailed description
This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune Grass in subjects with a documented history of allergic rhinoconjunctivitis on exposure to grass. The efficacy of ToleroMune HDM will also be explored LPSR, EPSR, CPT and levels of grass specific IgE.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 6 weeks before randomisation.
Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart. The first cohort will receive the lowest dose and successive dose groups will increasing doses of ToleroMune Grass, provided the first administration of the previous dose was safe and well tolerated.
In Period 3, 2 Post-treatment Challenge visits will take place, the first will be 2 weeks after the last administration in the Treatment Period and the second will be 17 weeks after the first administration. Follow-up will be conducted 3-10 days after the second PTC.
- Conditions
- Allergy
- Being tested
- Placebo, ToleroMune Grass
- Keywords
- Grass Allergy, Immunotherapy, Rhinoconjunctivitis, ToleroMune Grass
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Solution resembling active solution but without peptides
ToleroMune GrassBiological
1 x4 administrations 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects to receive either active or placebo Receives: Biological: Placebo; Biological: ToleroMune Grass |
| Cohort 2 | Experimental | Subjects to receive either active or placebo comparator Receives: Biological: Placebo; Biological: ToleroMune Grass |
| Cohort 3 | Experimental | Subjects to receive either active or placebo comparator Receives: Biological: Placebo; Biological: ToleroMune Grass |
| Cohort 4 | Experimental | Subjects to receive either active or placebo comparator Receives: Biological: Placebo; Biological: ToleroMune Grass |
| Cohort 5 | Experimental | Subjects to receive either active or placebo comparator Receives: Biological: Placebo; Biological: ToleroMune Grass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis
Measured: Upto 22 weeks
Secondary outcomes (12)
Area of Late Phase Skin Response
Measured: Baseline and 14 weeks
Area of Early Phase Skin Response
Measured: Baseline and 14 weeks
Change in CPT score
Measured: Baseline and 4 weeks
Grass specific IgG4
Measured: Baseline and 14 weeks
Change in CPT score
Measured: Baseline and 14 weeks
Area of Early Phase Skin Response
Measured: Baseline and 17 weeks
Grass specific IgE
Measured: Baseline and 17 weeks
Area of Late Phase Skin Response
Measured: Baseline and 17 weeks
Change in CPT score
Measured: 17 weeks after start of treatment
Change in CPT score
Measured: Baseline and 8 weeks
Change in CPT score
Measured: Baseline and 12 weeks
Grass specific IgE
Measured: Baseline and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Investigators
- Jacques Hebert, MD, Principal investigator, Centre de recherche appliquée en allergie de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166061
- Sponsor's protocol ID
- TG001
- Status last verified
- May 2011
- First submitted
- 8 Jul 2010
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Escalating, Multiple-dose Study in Grass Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Grass
- ClinicalTrials.gov ID
- NCT01166061
- Acronym / sponsor ID
- TG001
- Conditions
- Allergy
- Keywords
- Grass Allergy, Immunotherapy, Rhinoconjunctivitis, ToleroMune Grass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Jul 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.
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 40% of allergic patients are sensitized 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.
The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Grass in subjects allergic to grass.
Detailed description
This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune Grass in subjects with a documented history of allergic rhinoconjunctivitis on exposure to grass. The efficacy of ToleroMune HDM will also be explored LPSR, EPSR, CPT and levels of grass specific IgE.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 6 weeks before randomisation.
Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart. The first cohort will receive the lowest dose and successive dose groups will increasing doses of ToleroMune Grass, provided the first administration of the previous dose was safe and well tolerated.
In Period 3, 2 Post-treatment Challenge visits will take place, the first will be 2 weeks after the last administration in the Treatment Period and the second will be 17 weeks after the first administration. Follow-up will be conducted 3-10 days after the second 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 |
|---|---|---|
| Cohort 1 | Experimental | Biological: Placebo, Biological: ToleroMune GrassSubjects to receive either active or placebo |
| Cohort 2 | Experimental | Biological: Placebo, Biological: ToleroMune GrassSubjects to receive either active or placebo comparator |
| Cohort 3 | Experimental | Biological: Placebo, Biological: ToleroMune GrassSubjects to receive either active or placebo comparator |
| Cohort 4 | Experimental | Biological: Placebo, Biological: ToleroMune GrassSubjects to receive either active or placebo comparator |
| Cohort 5 | Experimental | Biological: Placebo, Biological: ToleroMune GrassSubjects to receive either active or placebo comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 18-65 years
- Minimum 2 year history of rhinoconjunctivitis on exposure to grass
- Positive skin prick test to whole grass allergen
- LPSR to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
- Positive CPT to whole grass allergen with a score ≥4
Key exclusion criteria (7 listed)
- Subjects with a history of asthma
- Subjects with an FEV1 <80% of predicted
- Subjects with a rye grass specific IgE >100 kU/L
- Subjects with an acute phase skin response to whole grass allergen with a mean wheal diameter > 50 mm
- Subjects who score >1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the CPT
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 |
|---|---|---|
| PlaceboSolution resembling active solution but without peptides | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| ToleroMune Grass1 x4 administrations 4 weeks apart | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis
Time frame: Upto 22 weeks
12 secondary outcomes
Area of Late Phase Skin Response
Time frame: Baseline and 14 weeks
Area of Early Phase Skin Response
Time frame: Baseline and 14 weeks
Change in CPT score
Time frame: Baseline and 4 weeks
Grass specific IgG4
Time frame: Baseline and 14 weeks
Change in CPT score
Time frame: Baseline and 14 weeks
Area of Early Phase Skin Response
Time frame: Baseline and 17 weeks
Grass specific IgE
Time frame: Baseline and 17 weeks
Area of Late Phase Skin Response
Time frame: Baseline and 17 weeks
Change in CPT score
Time frame: 17 weeks after start of treatment
Change in CPT score
Time frame: Baseline and 8 weeks
Change in CPT score
Time frame: Baseline and 12 weeks
Grass specific IgE
Time frame: Baseline and 14 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 20 May 2011.
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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.
Jacques Hebert, MD principal investigator
Centre de recherche appliquée en allergie de Quebec
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 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 5 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 20 May 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. 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 and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis (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 20 May 2011.