Allergic RhinitisPhase 3AMASENCT04541004
Adolescent Mite Allergy Safety Evaluation
A Phase 3 study testing HDM SLIT-tablet in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 27 sites in 3 countries.
Trial summary
This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis. The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- HDM SLIT-tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 23 Sep 2020to 24 Apr 2021
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent
- Male or female subjects aged ≥12 to ≤17 years
- A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM
- Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening
- Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication
- The subject must be willing and able to comply with trial protocol and adhere to IMP treatment
Show all 15Show fewer
- Main Exclusion Criteria:
- A subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA)
- Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1
- Ongoing treatment with any allergy immunotherapy product at screening
- Severe chronic oral inflammation
- A diagnosis or history of eosinophilic oesophagitis
- Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration
- Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial
- Sexually active female of childbearing potential without medically accepted contraceptive method
Who cannot join
None listed.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
Slovakia12 sites
Ambulancia klinickej imunologie a alergologie
Banská Bystrica, 97405
ALIAN s.r.o.
Bardejov, 08501
Jocia s.r.o.
Bratislava, 82108
AlergoImuno centrum s.r.o. - Ambulancia alergologi
Kežmarok, 06001
ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie
Komárno, 94501
Alersa
Košice, 04022
Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin
Martin, 03659
NZZ Imunologicka ambulancia
Poprad, 05801
Alergo immunological center prešov
Prešov, 08001
Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o.
Rimavská Sobota, 901981
Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie
Šurany, 94201
Medimun s.r.o.
Trnava, 91701
Czechia8 sites
Alergologicka ambulance
Čáslav, 28601
Alergopraktik s.r.o.
Jablonec nad Nisou, 46601
Allergology Jihlava
Jihlava, 58601
Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a
Kolín
Alergologicka ordinace
Kutná Hora, 28401
Alergomyšl s.r.o.
Litomyšl, 57014
Alergologie SKOPKOVA s.r.o.
Ostrava, 70900
KASMED s.r.o.
Tábor, 39002
Germany7 sites
Kinderarztpraxis BramscheDr. Thomas Adelt
Bramsche, Lower Saxony, 49565
Praxis Dr. Decot
Dreieich, Hesse, 63303
HNO-Praxis Dr. med. Udo Schaefer
Dresden, Saxony, 01067
Facharzt fr HNO und Allergologie
Dresden, Saxony, 013999
HNO Praxis am Neckar
Heidelberg, Baden-Wrttemberg, 69120
Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
Heidelberg, Baden-Wurttemberg, 69126
HNO-Genossenschaft Sachsen-Anhalt E.G.
Wolmirstedt, Saxony-Anhalt, 39326
About this study
Official title: A 28-day, Single-armed, Open-label Trial to Evaluate Safety of the House Dust Mite (HDM) Sublingual Allergy Immunotherapy (SLIT) Tablet in Adolescent Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis.
The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies.
The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.
Read the detailed description
This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- HDM SLIT-tablet
- Keywords
- Allergic rhinitis, House dust mite, Adolescent, Pediatric
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM SLIT-tabletBiological
Also called ACARIZAX, ODACTRA
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
| Study group | Role | What they receive |
|---|---|---|
| HDM SLIT Tablet | Experimental | House dust mite (HDM) Sublingual allergy immunotherapy tablet Receives: Biological: HDM SLIT-tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
At least one TEAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
At least one TEAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Treatment-emergent Adverse Events (TEAEs)
At least one TEAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Secondary outcomes (9)
Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
At least one solicited TEAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
At least one solicited TEAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Solicited Treatment-emergent Adverse Events (TEAEs)
At least one solicited TEAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Subjects With at Least One IMP-related Adverse Event (AE)
At least one IMP-related AE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One IMP-related Adverse Event (AE)
At least one IMP-related AE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of IMP-related Adverse Events (AEs)
At least one IMP-related AE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
At least one treatment-emergent SAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
At least one treatment-emergent SAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Treatment-emergent Serious Adverse Events (SAEs)
At least one treatment-emergent SAE
Measured: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start23 Sep 2020
- Primary completion24 Apr 2021
- Study completion24 Apr 2021
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 Allergic RhinitisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- single-armed
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Andreas Horn, MD, Principal investigator, HNO Praxis am Neckar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541004
- Sponsor's protocol ID
- MT-18
- Other IDs
- 2020-000446-34
- Acronym
- AMASE
- Status last verified
- Jul 2022
- First submitted
- 1 Sep 2020
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-day, Single-armed, Open-label Trial to Evaluate Safety of the House Dust Mite (HDM) Sublingual Allergy Immunotherapy (SLIT) Tablet in Adolescent Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
- ClinicalTrials.gov ID
- NCT04541004
- Acronym / sponsor ID
- AMASE / MT-18
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- Allergic rhinitis, House dust mite, Adolescent, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 24 Apr 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis.
The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies.
The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.
Detailed description
This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-armed
| Arm | Type | Receives |
|---|---|---|
| HDM SLIT Tablet | Experimental | Biological: HDM SLIT-tabletHouse dust mite (HDM) Sublingual allergy immunotherapy tablet |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Written informed consent
- Male or female subjects aged ≥12 to ≤17 years
- A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM
- Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening
- Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HDM SLIT-tabletAlso: ACARIZAX, ODACTRASublingual allergy immunotherapy tablet, for daily administration (1 tablet per day) | Biological | HDM SLIT Tablet |
Primary outcome
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
At least one TEAE
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
At least one TEAE
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
At least one TEAE
9 secondary outcomes
Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Solicited Treatment-emergent Adverse Events (TEAEs)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Subjects With at Least One IMP-related Adverse Event (AE)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One IMP-related Adverse Event (AE)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of IMP-related Adverse Events (AEs)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Treatment-emergent Serious Adverse Events (SAEs)
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
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.
Andreas Horn, MD principal investigator
HNO Praxis am Neckar
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDM SLIT-tablet in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 27 sites in 3 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 15 inclusion and 0 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Slovakia, Czechia, 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. 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 3 Jul 2023). 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?
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) (time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.). The study lists 3 primary outcomes in all. 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 3 Jul 2023.