House Dust Mite AllergyPhase 2NCT03094845
Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients
A Phase 2 study testing hdmASIT+TM in people with House Dust Mite Allergy, run by ASIT Biotech S.A. at 1 site in Germany.
Trial summary
hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- House Dust Mite Allergy
- What is being tested?
- hdmASIT+TM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 28 Sep 2016to 23 Jan 2017
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al., 2001))
- A positive skin prick test to house dust mite Dermatophagoides pteronyssinus
- Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L
- Positive response to Conjunctival Provocation Test (CPT)
- Being treated with anti-allergic medication for at least 12 months prior to enrollment
- For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value
Who cannot join
- Previous immunotherapy with house dust mite allergens within the last 5 years
- Ongoing immunotherapy with house dust mite allergens or any other allergens
- History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
- Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
- Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient's reference value (ECSC)
- History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety and Clinical Tolerability of hdmASIT+TM Administered Subcutaneously in House Dust Mite-induced Allergic Rhinoconjunctivitis Patients
hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.
- Conditions
- House Dust Mite Allergy
- Being tested
- Placebo solution, hdmASIT+TM
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo solutionBiological
15 injections over 7 weeks
hdmASIT+TMBiological
15 injections over 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo solution |
| hdmASIT+TM | Experimental | Not described Receives: Biological: hdmASIT+TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited adverse events
- Local reactions at the injection site
- Allergic systemic reactions
Measured: up to 7 weeks
Secondary outcomes (4)
Unsolicited adverse events and serious adverse events (SAEs)
Measured: up to 12 weeks
Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure)
Measured: up to 12 weeks
Laboratory investigations (haematology, clinical biochemistry, immunological parameters)
Measured: up to 12 weeks
Pulmonary functions (FEV1) for asthmatic patients
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start28 Sep 2016
- Primary completion12 Jan 2017
- Study completion23 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for House Dust Mite 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASIT Biotech S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094845
- Sponsor's protocol ID
- ABT-hdmASIT001
- Other IDs
- 2016-000557-13, 2016
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Clinical Tolerability of hdmASIT+TM Administered Subcutaneously in House Dust Mite-induced Allergic Rhinoconjunctivitis Patients
- ClinicalTrials.gov ID
- NCT03094845
- Acronym / sponsor ID
- ABT-hdmASIT001
- Conditions
- House Dust Mite Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ASIT Biotech S.A.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 23 Jan 2017 (actual)
- First posted
- 29 Mar 2017 (actual)
- 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.
hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo solution |
| hdmASIT+TM | Experimental | Biological: hdmASIT+TM |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al., 2001))
- A positive skin prick test to house dust mite Dermatophagoides pteronyssinus
- Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L
- Positive response to Conjunctival Provocation Test (CPT)
- Being treated with anti-allergic medication for at least 12 months prior to enrollment
Key exclusion criteria (6 listed)
- Previous immunotherapy with house dust mite allergens within the last 5 years
- Ongoing immunotherapy with house dust mite allergens or any other allergens
- History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
- Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
- Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient's reference value (ECSC)
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 |
|---|---|---|
| Placebo solution15 injections over 7 weeks | Biological | Placebo |
| hdmASIT+TM15 injections over 7 weeks | Biological | hdmASIT+TM |
Primary outcome
Solicited adverse events
Time frame: up to 7 weeks
* Local reactions at the injection site * Allergic systemic reactions
4 secondary outcomes
Unsolicited adverse events and serious adverse events (SAEs)
Time frame: up to 12 weeks
Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure)
Time frame: up to 12 weeks
Laboratory investigations (haematology, clinical biochemistry, immunological parameters)
Time frame: up to 12 weeks
Pulmonary functions (FEV1) for asthmatic patients
Time frame: up to 7 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 29 Mar 2017.
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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 hdmASIT+TM in people with House Dust Mite Allergy, run by ASIT Biotech S.A. at 1 site in Germany.
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 6 inclusion and 6 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 29 Mar 2017. 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 Germany. 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?
Solicited adverse events (time frame: up to 7 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 29 Mar 2017.