RhinoconjunctivitisPhase 2NCT01949441
ToleroMune House Dust Mite (HDM) Tolerability Study
A Phase 2 study testing ToleroMune HDM in people with Rhinoconjunctivitis, run by Circassia Limited at 1 site in Canada.
Trial summary
House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and fabric. 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis
- What is being tested?
- ToleroMune HDM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to May 2014
- 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.
- Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
- Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
- No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation.
- A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation
- Positive skin prick test to Dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control.
- ImmunoCAP® Dermatophagoides pteronyssinus-specific Immunoglobulin E ≥ 0.35 kU/L.
Who cannot join
- History of life-threatening asthma
- Asthma exacerbation in the 12 weeks prior to randomisation
- Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) < 80 % of predicted, regardless of the cause.
- Post-bronchodilator FEV1/Forced Vital Capacity ratio of < 0.7.
- Concurrent respiratory disease that would confound study participation or affect subject safety.
- Non-HDM allergy that may significantly interfere with the results of this study.
- 7. Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Tolerability of ToleroMune House Dust Mite in Subjects With Controlled Asthma and House Dust Mite-Induced Rhinoconjunctivitis
House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and fabric. 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. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.
ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.
This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.
Read the detailed description
A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.
- Conditions
- Rhinoconjunctivitis
- Being tested
- ToleroMune HDM, Placebo
- Keywords
- HDM Allergy, Rhinoconjunctivitis, Immunotherapy, ToleroMune HDM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToleroMune HDMBiological
Intradermal injection 1 x 4 administrations 4 weeks apart
PlaceboBiological
Intradermal injection 1 x 4 administrations 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| ToleroMune HDM | Experimental | Not described Receives: Biological: ToleroMune HDM |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Up to 19 Weeks
Secondary outcomes (6)
FEV1 and FVC
Measured: Up to 19 Weeks
Peak Expiratory Flow Rate
Measured: Up to 19 Weeks
VAS Breathlessness
Measured: Up to 19 weeks
Asthma Exacerbations
Measured: Up to 19 weeks
Systemic Allergic Reactions
Measured: Up to 19 Weeks
Injection Site Examinations
Measured: Up to 19 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoconjunctivitisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949441
- Sponsor's protocol ID
- TH004
- Status last verified
- Jun 2014
- First submitted
- 20 Sep 2013
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Tolerability of ToleroMune House Dust Mite in Subjects With Controlled Asthma and House Dust Mite-Induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01949441
- Acronym / sponsor ID
- TH004
- Conditions
- Rhinoconjunctivitis
- Keywords
- HDM Allergy, Rhinoconjunctivitis, Immunotherapy, ToleroMune HDM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Sep 2013 (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.
House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and fabric. 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. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.
ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.
This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.
Detailed description
A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ToleroMune HDM | Experimental | Biological: ToleroMune HDM |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18-65 years.
- Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
- Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
- No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation.
- A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation
Key exclusion criteria (7 listed)
- History of life-threatening asthma
- Asthma exacerbation in the 12 weeks prior to randomisation
- Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) < 80 % of predicted, regardless of the cause.
- Post-bronchodilator FEV1/Forced Vital Capacity ratio of < 0.7.
- Concurrent respiratory disease that would confound study participation or affect subject safety.
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 HDMIntradermal injection 1 x 4 administrations 4 weeks apart | Biological | ToleroMune HDM |
| PlaceboIntradermal injection 1 x 4 administrations 4 weeks apart | Biological | Placebo |
Primary outcome
Adverse Events
Time frame: Up to 19 Weeks
6 secondary outcomes
FEV1 and FVC
Time frame: Up to 19 Weeks
Peak Expiratory Flow Rate
Time frame: Up to 19 Weeks
VAS Breathlessness
Time frame: Up to 19 weeks
Asthma Exacerbations
Time frame: Up to 19 weeks
Systemic Allergic Reactions
Time frame: Up to 19 Weeks
Injection Site Examinations
Time frame: Up to 19 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 11 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 7 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 11 Jun 2014. 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?
Adverse Events (time frame: Up to 19 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 11 Jun 2014.