House Dust Mite AllergyPhase 1/2DTSNCT02345278
SUBLIVAC FIX Mite Mixture Dose Tolerability Study
A Phase 1/2 study testing SUBLIVAC FIX Mite mixture in people with House Dust Mite Allergy, run by HAL Allergy at 10 sites in Germany.
Trial summary
Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy and specific immunotherapy (IT). IT represents the only treatment that might alter the natural course of the disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- House Dust Mite Allergy
- What is being tested?
- SUBLIVAC FIX Mite mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 10 sitesGermany
- Study dates
- May 2015to Nov 2015
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Male or female patients, age ≥ 18 ≤ 60 years
- Patients with allergic rhinitis or rhinoconjunctivitis induced by HDM for at least 1 year, with or without concomitant at least partly controlled asthma
- Patients with a history of concomitant asthma should have a FEV1 > 70% (of predicted value) at inclusion. Patients without a history of asthma should have a FEV1 > 70% or a PEF > 80% (of predicted value)
- Positive SPT to HDM D. pter or D. far (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) at screening
- Allergen specific serum IgE (ssIgE) level in serum for HDM D. pter or D. far (> 0.7 U/ml), assessed at screening
Who cannot join
- Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) who are expected to have clinically relevant symptoms during the treatment period
- Patients sensitized and symptomatic to pets who are regularly exposed to pets
- Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
- Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years
- Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period
- Any other vaccination one week before start of treatment and during the up-dosing phase
Show all 24Show fewer
- Any anti-IgE therapy within the last 6 months prior to inclusion and during study
- Active inflammatory disease in the mouth (e.g periodontitis, oral mucosal lichen planus)
- Known hypersensitivity to any of the excipients (i.e. Disodium phosphate dihydrate, Sodium dihydrogen phosphate dihydrate, Aminocaproic acid, Glycerol, Peppermint oil, Caramel Colorant) of SLIT solution
- Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
- Active malignancies or any malignant disease in the last 5 years
- A chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders
- Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
- Use of systemic corticosteroids 4 weeks before start treatment
- Treatment with systemic or local beta-blockers
- Clinically significant chronic sinusitis or ocular infection
- Participation in a clinical study with a new investigational drug within the last 3 months or a biological within the last 6 months prior to the study or during the study
- Pregnancy, lactation or inadequate contraceptive measures (acceptable forms of birth control include Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections) or condom combined with a diaphragm including spermicidal cream). Also acceptable for women is surgical sterilization (removal of the uterus or ovaries or tubal ligation ("tied tubes")), if they are postmenopausal (12 consecutive months without a period) for at least 2 years, or having no sexual relationship with a man.
- Alcohol, drug, or medication abuse within the past year and during the study
- Any lack of co-operation or compliance
- Severe psychiatric, psychological, or neurological disorders
- Patients who are employees of the department or study site; 1st grade relatives, partners of the investigator, or patients who are dependent on the sponsor
- Any physical or mental condition that precludes administration of allergen-specific immunotherapy, compliance or participation in a trial
- Patients who are placed in an institution due to governmental or judicial directive
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Charite Universitatsmedizin Berlin, Allergiezentrum
Berlin, D-10117
Praxis Dr.med.Elke Hippke
Berlin, D-13057
HNO-Heilkunde Praxis
Chemnitz, D-09130
HNO und Allergologie Praxis
Dresden, D-01139
HNO-Praxis Dr. Uta Thieme
Duisburg, D-47051
Universitatsklinikum Dusseldorf, Department Dermatology
Düsseldorf, D-40225
HNO Praxis Gottingen
Göttingen, D-37073
HNO Praxis am Neckar
Heidelberg, D-69120
HNO Gemeinschaftspraxis
Heidelberg, D-69126
Dr.med. Ulrich Neumann Praxis
Wolmirstedt, D-39326
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Determine Tolerability and Safety of Different Dosages of SUBLIVAC FIX Mite Mixture in Patients With Allergic Rhinitis / Rhinoconjunctivitis Caused by House Dust Mites
Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy and specific immunotherapy (IT). IT represents the only treatment that might alter the natural course of the disease. The amount of administered allergen is crucial for both efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens.
According to the European Medicines Agency Guideline on the clinical development of products for specific IT for the treatment of allergic diseases, products should be tested at different dosages to provide preliminary data on safety and tolerability with regard to the maximum tolerated dose and suitable dose escalation scheme. This trial is designed to investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.
- Conditions
- House Dust Mite Allergy
- Being tested
- SUBLIVAC FIX Mite mixture, Placebo
- Keywords
- Immunotherapy, Allergic rhinitis/rhinoconjunctivitis
- Medical subject headings
- Dust Mite Allergy, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUBLIVAC FIX Mite mixtureDrug
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
PlaceboOther
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | once daily sublingual administration for 1 month Receives: Other: Placebo |
| SUBLIVAC FIX Mite mixture 10,000 AU/mL | Active comparator | once daily sublingual administration for 1 month Receives: Drug: SUBLIVAC FIX Mite mixture |
| SUBLIVAC FIX Mite mixture 25,000 AU/mL | Active comparator | once daily sublingual administration for 1 month Receives: Drug: SUBLIVAC FIX Mite mixture |
| SUBLIVAC FIX Mite mixture 50,000 AU/mL | Active comparator | once daily sublingual administration for 1 month Receives: Drug: SUBLIVAC FIX Mite mixture |
| SUBLIVAC FIX Mite mixture 100,000 AU/mL | Active comparator | once daily sublingual administration for 1 month Receives: Drug: SUBLIVAC FIX Mite mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SUBLIVAC FIX Mite mixture (assessed by number and severity of local and systemic reactions)
Safety and tolerability of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by number and severity of local and systemic reactions.
Measured: 1 month treatment
Secondary outcomes (4)
Adverse Events
Safety of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by number and severity of Adverse Events
Measured: 1 month treatment
Clinical and laboratory parameters (Safety of different dosages of SUBLIVAC FIX Mite mixture)
Safety of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by clinical and laboratory parameters
Measured: 1 month treatment
Changes in immunoglobulin levels ((IgE, IgG, IgG4)
Changes in serum specific immunoglobulin levels (IgE, IgG, IgG4) after 1 month of treatment with different dosages of SUBLIVAC FIX Mite mixture compared to placebo
Measured: 1 month
Proportion of patients reaching maintenance dose within 10 days
Proportions of patients in the different treatment groups reaching maintenance dose within 10 days
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margitta Worm, Prof.Dr.med., Study chair, Allergie-Centrum-Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345278
- Sponsor's protocol ID
- SM/0044
- Acronym
- DTS
- Status last verified
- Dec 2015
- First submitted
- 19 Jan 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Determine Tolerability and Safety of Different Dosages of SUBLIVAC FIX Mite Mixture in Patients With Allergic Rhinitis / Rhinoconjunctivitis Caused by House Dust Mites
- ClinicalTrials.gov ID
- NCT02345278
- Acronym / sponsor ID
- DTS / SM/0044
- Conditions
- House Dust Mite Allergy
- Keywords
- Immunotherapy, Allergic rhinitis/rhinoconjunctivitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Jan 2015 (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.
Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy and specific immunotherapy (IT). IT represents the only treatment that might alter the natural course of the disease. The amount of administered allergen is crucial for both efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens.
According to the European Medicines Agency Guideline on the clinical development of products for specific IT for the treatment of allergic diseases, products should be tested at different dosages to provide preliminary data on safety and tolerability with regard to the maximum tolerated dose and suitable dose escalation scheme. This trial is designed to investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placeboonce daily sublingual administration for 1 month |
| SUBLIVAC FIX Mite mixture 10,000 AU/mL | Active comparator | Drug: SUBLIVAC FIX Mite mixtureonce daily sublingual administration for 1 month |
| SUBLIVAC FIX Mite mixture 25,000 AU/mL | Active comparator | Drug: SUBLIVAC FIX Mite mixtureonce daily sublingual administration for 1 month |
| SUBLIVAC FIX Mite mixture 50,000 AU/mL | Active comparator | Drug: SUBLIVAC FIX Mite mixtureonce daily sublingual administration for 1 month |
| SUBLIVAC FIX Mite mixture 100,000 AU/mL | Active comparator | Drug: SUBLIVAC FIX Mite mixtureonce daily sublingual administration for 1 month |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Male or female patients, age ≥ 18 ≤ 60 years
- Patients with allergic rhinitis or rhinoconjunctivitis induced by HDM for at least 1 year, with or without concomitant at least partly controlled asthma
- Patients with a history of concomitant asthma should have a FEV1 > 70% (of predicted value) at inclusion. Patients without a history of asthma should have a FEV1 > 70% or a PEF > 80% (of predicted value)
- Positive SPT to HDM D. pter or D. far (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) at screening
Key exclusion criteria (24 listed)
- Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) who are expected to have clinically relevant symptoms during the treatment period
- Patients sensitized and symptomatic to pets who are regularly exposed to pets
- Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
- Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years
- Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period
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 |
|---|---|---|
| SUBLIVAC FIX Mite mixtureStudy medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month. | Drug | SUBLIVAC FIX Mite mixture 10,000 AU/mL, SUBLIVAC FIX Mite mixture 100,000 AU/mL, SUBLIVAC FIX Mite mixture 25,000 AU/mL, SUBLIVAC FIX Mite mixture 50,000 AU/mL |
| PlaceboStudy medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month. | Other | Placebo |
Primary outcome
Safety and tolerability of SUBLIVAC FIX Mite mixture (assessed by number and severity of local and systemic reactions)
Time frame: 1 month treatment
Safety and tolerability of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by number and severity of local and systemic reactions.
4 secondary outcomes
Adverse Events
Time frame: 1 month treatment
Clinical and laboratory parameters (Safety of different dosages of SUBLIVAC FIX Mite mixture)
Time frame: 1 month treatment
Changes in immunoglobulin levels ((IgE, IgG, IgG4)
Time frame: 1 month
Proportion of patients reaching maintenance dose within 10 days
Time frame: 10 days
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 2 Dec 2015.
Related trials for House Dust Mite Allergy
Not yet recruitingPhase 3
Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab
Severe Asthma, Allergy to House Dust Mites
Not yet recruitingPhase 2/3
Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract
Allergic Rhinitis, Allergic Asthma
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.
Margitta Worm, Prof.Dr.med. study chair
Allergie-Centrum-Charité
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SUBLIVAC FIX Mite mixture in people with House Dust Mite Allergy, run by HAL Allergy at 10 sites 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 24 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 SUBLIVAC FIX Mite mixture (assessed by number and severity of local and systemic reactions) (time frame: 1 month treatment). 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 2 Dec 2015; AzTrials last refreshed its copy on 27 Oct 2026.