AllergyPhase 3NCT02596321
A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma
A Phase 3 study testing Mitizax in people with Allergy and Asthma, run by Abbott at 9 sites in 2 countries.
Trial summary
To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Mitizax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Oct 2015to Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent obtained before entering the study
- Patients 18-65 years of age, with a clinical history consistent with HDM-induced allergic rhinitis or allergic rhinoconjunctivitis with or without HDM-induced allergic atopic asthma for more than 1 year
- Use of symptomatic treatment of HDM-induced allergic rhinitis and/or HDM-induced atopic asthma, i.e. antihistamines, nasal decongestants, nasal and/or inhaled corticosteroid for more than 1 year
- if HDM-induced atopic asthma is present, it should be of mild to moderate severity, controlled on treatment corresponding to steps 1-3 of The Global initiative for asthma (GINA)
- Positive skin prick test response (wheal diameter ≥3 mm) to D pteronyssinus and/or D.farinae
- Moderate or higher level of D.pteronyssinus and/or D.farinae specific IgE (defined as ≥IgE Class 2; or ≥0.70 kilo unit (kU)/L)
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- Patient one of the following:
- Male
- Female, infertile
- Female, with a negative pregnancy test and willingness to practice appropriate contraceptive methods until treatment with study drug has been discontinued.
- Patient willing and able to comply with study protocol
Who cannot join
- Previous treatment with HDM immunotherapy for more than 1 month within the last 5 years
- Ongoing treatment with any allergen-specific immunotherapy product
- Reduced lung function (defined as Forced expiratory volume in 1 second (FEV1) < 70% of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
- Clinical history of uncontrolled asthma within 3 months prior to the screening visit
- Having experienced a severe asthma exacerbation within 3 months prior to screening visit
- Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization
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- Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomization
- History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction)
- History of recurrent generalized urticaria (defined as two or more episodes) during the last 2 years
- A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
- Any chronic disease (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality or any other diseases that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject)
- Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not)
- Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
- Currently treated with tricyclic antidepressants; catecholamine-O-methyltransferase (COMT) inhibitors and mono amine oxidase inhibitors (MAOIs) and beta-blockers including topical administration
- Use of medication at the screening visit which at the time of skin prick test (SPT) can interfere with the result (i.e. antihistamines)
- Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to the screening visit
- History of allergy, hypersensitivity or intolerance to a excipient in the investigational medicinal product (except D.Pteronyssinus and D.farinae)
- Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild
- Severe mental disorders that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject
- Cardiovascular conditions in which complications are possible when using adrenaline
- Women who are pregnant or breastfeeding
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Russia7 sites
Kazan State Medical Academy
Kazan', 420103
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
Moscow, 115478
"Russian Medical Academy of Postgraduate Education Studies
Moscow, 123182
City out-patient's clinic # 94
Saint Petersburg, 193231
Smolensk State Medical Academy
Smolensk
Hospital of Russian Academy of Science
Troitsk, 142190
Bashkirskiy State Medical University
Ufa
Belarus2 sites
Minsk Regional Clinical Hospital
Minsk, 220041
City Clinical Hopsital #10
Minsk, 220096
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis and/or Atopic Asthma Induced by House Dust Mites
To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.
Read the detailed description
To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days
To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days, compared to placebo
To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo
- Being tested
- Mitizax, Placebo
- Keywords
- House Dust Mite
- Medical subject headings
- Hypersensitivity, Asthma, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitizaxDrug
Also called ALK HDM tablet, allergen extract
Allergen extract
PlaceboDrug
Also called Placebo tablet
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Mitizax ALK HDM tablet | Experimental | Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU) Receives: Drug: Mitizax |
| Placebo tablet | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
D. Farinae Specific IgG4 Change From Baseline to End of Treatment
primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment
Measured: 60 days from baseline
Secondary outcomes (3)
D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment
secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment
Measured: 60 days from baseline
D. Farinae Specific IgE Change From Baseline to End of Treatment
the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo
Measured: 60 days from baseline
D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment
the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo
Measured: 60 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Linical Co., Ltd., Datamap
- Responsible party
- Sponsor
- Investigators
- Dmitri Kazei, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596321
- Sponsor's protocol ID
- MITI3001
- Status last verified
- Feb 2018
- First submitted
- 2 Nov 2015
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis and/or Atopic Asthma Induced by House Dust Mites
- ClinicalTrials.gov ID
- NCT02596321
- Acronym / sponsor ID
- MITI3001
- Keywords
- House Dust Mite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Linical Co., Ltd., Datamap
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Posted 18 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.
Detailed description
To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days
To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days, compared to placebo
To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitizax ALK HDM tablet | Experimental | Drug: MitizaxStandardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU) |
| Placebo tablet | Placebo comparator | Drug: PlaceboPlacebo tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent obtained before entering the study
- Patients 18-65 years of age, with a clinical history consistent with HDM-induced allergic rhinitis or allergic rhinoconjunctivitis with or without HDM-induced allergic atopic asthma for more than 1 year
- Use of symptomatic treatment of HDM-induced allergic rhinitis and/or HDM-induced atopic asthma, i.e. antihistamines, nasal decongestants, nasal and/or inhaled corticosteroid for more than 1 year
- if HDM-induced atopic asthma is present, it should be of mild to moderate severity, controlled on treatment corresponding to steps 1-3 of The Global initiative for asthma (GINA)
- Positive skin prick test response (wheal diameter ≥3 mm) to D pteronyssinus and/or D.farinae
Key exclusion criteria (21 listed)
- Previous treatment with HDM immunotherapy for more than 1 month within the last 5 years
- Ongoing treatment with any allergen-specific immunotherapy product
- Reduced lung function (defined as Forced expiratory volume in 1 second (FEV1) < 70% of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
- Clinical history of uncontrolled asthma within 3 months prior to the screening visit
- Having experienced a severe asthma exacerbation within 3 months prior to screening visit
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 |
|---|---|---|
| MitizaxAlso: ALK HDM tablet, allergen extractAllergen extract | Drug | Mitizax ALK HDM tablet |
| PlaceboAlso: Placebo tabletPlacebo tablet | Drug | Placebo tablet |
Primary outcome
D. Farinae Specific IgG4 Change From Baseline to End of Treatment
Time frame: 60 days from baseline
primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment
3 secondary outcomes
D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment
Time frame: 60 days from baseline
D. Farinae Specific IgE Change From Baseline to End of Treatment
Time frame: 60 days from baseline
D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment
Time frame: 60 days from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dmitri Kazei, MD study director
Abbott
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitizax in people with Allergy and Asthma, run by Abbott at 9 sites in 2 countries.
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 11 inclusion and 21 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia, Belarus. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
D. Farinae Specific IgG4 Change From Baseline to End of Treatment (time frame: 60 days from baseline). 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 1 Mar 2018.