AllergyPhase 2NCT01008332
Safety of ToleroMune House Dust Mite (HDM) to Treat House Dust Mite Allergy in HDM Allergic Subjects With Rhinoconjunctivitis
A Phase 2 study testing Toleromune HDM in people with Allergy, run by Circassia Limited at 1 site in Canada.
Trial summary
The prevalence of allergic sensitisation to House Dust Mite (HDM) varies from region to region and depends on the regional prevalence of HDM. In the third National Health and Nutrition Examination Surveys, 54.3% of the US population had positive test responses to one or more allergens, with the prevalence for HDM… 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 HDM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Aug 2010
- 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
- Miniumum 1 year history of rhinoconjunctivitis on exposure to HDM
- Positive skin prick test to whole Der p allergen
- LPSR to whole Der p allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
- Positive CPT to whole Der p allergen with a score ≥4
Who cannot join
- Subjects with a history of asthma
- Subjects with an FEV1 <80% of predicted
- Subjects with a Der f or Der p specific IgE >100 kU/L
- Subjects with an acute phase skin response to whole Der p or whole Der f 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, tranquillizers 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.
About this study
Official title: An Escalating, Multiple-dose Study in House Dust Mite Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune HDM
The prevalence of allergic sensitisation to House Dust Mite (HDM) varies from region to region and depends on the regional prevalence of HDM. In the third National Health and Nutrition Examination Surveys, 54.3% of the US population had positive test responses to one or more allergens, with the prevalence for HDM being 27.5%. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms.
ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of Houst Dust Mite allergy.
The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune HDM in subjects in subjects with a documented history of allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM will also be explored in these subjects using the Late Phase Skin Response, Early Phase Skin Response and Conjunctival Provocation Test.
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 HDM in subjects with a documented history of allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM will also be explored in these subjects using the LPSR, EPSR, CPT and levels of HDM specific IgE. A single centre will be initiated first, with a second centre included as a backup, if needed, to enable recruitment numbers to be met.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4 weeks before randomisation.
Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart (28±2 days). Subjects who comply with the inclusion/exclusion criteria will be assigned to one of 5 dose groups. The first dose group will receive 4 administrations of ToleroMune HDM. Successive dose groups will increasing doses given as 4 administrations of ToleroMune HDM, provided the first administration of the previous dose was safe and well tolerated.
In Period 3, Post-treatment Challenge will take place 18-22 weeks after the first administration in the Treatment Period. Assessments performed will be identical to those at the Baseline Challenge. Follow-up will be conducted 3-10 days after PTC.
- Conditions
- Allergy
- Being tested
- Toleromune HDM, Placebo
- Keywords
- House Dust Mite Allergy, Immunotherapy, Rhinoconjunctivitis, Toleromune HDM
- Medical subject headings
- Hypersensitivity, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toleromune HDMBiological
ToleroMune HDM dose 1x4 administrations 4 weeks apart
PlaceboBiological
Placebo comparator, 1x4 administrations 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | ToleroMune HDM, subjects to receive either active or placebo comparator Receives: Biological: Toleromune HDM; Biological: Placebo |
| Cohort 2 | Experimental | ToleroMune HDM, subjects to receive either active or placebo comparator Receives: Biological: Toleromune HDM; Biological: Placebo |
| Cohort 3 | Experimental | ToleroMune HDM, subjects to receive either active or placebo comparator Receives: Biological: Toleromune HDM; Biological: Placebo |
| Cohort 4 | Experimental | ToleroMune HDM, subjects to receive either active or placebo comparator Receives: Biological: Toleromune HDM; Biological: Placebo |
| Cohort 5 | Experimental | Toleromune HDM, subjects to receive either active or placebo comparator Receives: Biological: Toleromune HDM; Biological: Placebo |
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 HDM in HDM allergic subjects with allergic rhinoconjunctivitis
Measured: 18-22 weeks
Secondary outcomes (4)
Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole HDM allergen at PTC after ToleroMune HDM injection compared to placebo
Measured: 18-22 weeks
Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole HDM allergen at PTC after ToleroMune HDM injection compared to placebo
Measured: 18-22 weeks
Mean change from baseline in CPT score at PTC after ToleroMune HDM injection compared to placebo
Measured: 18-22 weeks
Mean change from baseline in concentration of HDM specific IgE at PTC after ToleroMune HDM injection compared to placebo
Measured: 18-22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionAug 2010
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
- Double blind
- Who is masked
- Participant, Investigator
- 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 Appliqué en Allergie de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008332
- Sponsor's protocol ID
- TH001
- Status last verified
- Nov 2010
- First submitted
- 4 Nov 2009
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Escalating, Multiple-dose Study in House Dust Mite Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune HDM
- ClinicalTrials.gov ID
- NCT01008332
- Acronym / sponsor ID
- TH001
- Conditions
- Allergy
- Keywords
- House Dust Mite Allergy, Immunotherapy, Rhinoconjunctivitis, Toleromune HDM
- 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
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Nov 2009 (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 prevalence of allergic sensitisation to House Dust Mite (HDM) varies from region to region and depends on the regional prevalence of HDM. In the third National Health and Nutrition Examination Surveys, 54.3% of the US population had positive test responses to one or more allergens, with the prevalence for HDM being 27.5%. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms.
ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of Houst Dust Mite allergy.
The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune HDM in subjects in subjects with a documented history of allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM will also be explored in these subjects using the Late Phase Skin Response, Early Phase Skin Response and Conjunctival Provocation Test.
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 HDM in subjects with a documented history of allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM will also be explored in these subjects using the LPSR, EPSR, CPT and levels of HDM specific IgE. A single centre will be initiated first, with a second centre included as a backup, if needed, to enable recruitment numbers to be met.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4 weeks before randomisation.
Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart (28±2 days). Subjects who comply with the inclusion/exclusion criteria will be assigned to one of 5 dose groups. The first dose group will receive 4 administrations of ToleroMune HDM. Successive dose groups will increasing doses given as 4 administrations of ToleroMune HDM, provided the first administration of the previous dose was safe and well tolerated.
In Period 3, Post-treatment Challenge will take place 18-22 weeks after the first administration in the Treatment Period. Assessments performed will be 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
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Toleromune HDM, Biological: PlaceboToleroMune HDM, subjects to receive either active or placebo comparator |
| Cohort 2 | Experimental | Biological: Toleromune HDM, Biological: PlaceboToleroMune HDM, subjects to receive either active or placebo comparator |
| Cohort 3 | Experimental | Biological: Toleromune HDM, Biological: PlaceboToleroMune HDM, subjects to receive either active or placebo comparator |
| Cohort 4 | Experimental | Biological: Toleromune HDM, Biological: PlaceboToleroMune HDM, subjects to receive either active or placebo comparator |
| Cohort 5 | Experimental | Biological: Toleromune HDM, Biological: PlaceboToleromune HDM, subjects 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
- Miniumum 1 year history of rhinoconjunctivitis on exposure to HDM
- Positive skin prick test to whole Der p allergen
- LPSR to whole Der p allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
- Positive CPT to whole Der p 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 Der f or Der p specific IgE >100 kU/L
- Subjects with an acute phase skin response to whole Der p or whole Der f 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 |
|---|---|---|
| Toleromune HDMToleroMune HDM dose 1x4 administrations 4 weeks apart | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboPlacebo comparator, 1x4 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 HDM in HDM allergic subjects with allergic rhinoconjunctivitis
Time frame: 18-22 weeks
4 secondary outcomes
Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole HDM allergen at PTC after ToleroMune HDM injection compared to placebo
Time frame: 18-22 weeks
Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole HDM allergen at PTC after ToleroMune HDM injection compared to placebo
Time frame: 18-22 weeks
Mean change from baseline in CPT score at PTC after ToleroMune HDM injection compared to placebo
Time frame: 18-22 weeks
Mean change from baseline in concentration of HDM specific IgE at PTC after ToleroMune HDM injection compared to placebo
Time frame: 18-22 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 10 Nov 2010.
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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 Appliqué en Allergie de Québec
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 HDM 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 10 Nov 2010. 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 HDM in HDM allergic subjects with allergic rhinoconjunctivitis (time frame: 18-22 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 10 Nov 2010.