Adolescent Mite Allergy Safety Evaluation (AMASE)
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| ClinicalTrials.gov Identifier: NCT04541004 |
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Recruitment Status :
Completed
First Posted : September 9, 2020
Last Update Posted : July 19, 2021
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Sponsor:
ALK-Abelló A/S
Collaborator:
Syneos Health
Information provided by (Responsible Party):
ALK-Abelló A/S
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Brief 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 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Allergic Rhinitis Allergic Rhinoconjunctivitis | Biological: HDM SLIT-tablet | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 254 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | single-armed |
| Masking: | None (Open Label) |
| Masking Description: | Non applicable |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 23, 2020 |
| Actual Primary Completion Date : | April 24, 2021 |
| Actual Study Completion Date : | April 24, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Allergy
Drug Information available for:
Odactra
| Arm | Intervention/treatment |
|---|---|
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Experimental: HDM SLIT Tablet
House dust mite (HDM) Sublingual allergy immunotherapy tablet
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Biological: HDM SLIT-tablet
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Other Name: ACARIZAX, ODACTRA |
Primary Outcome Measures :
- 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 and proportion of subjects with at least one TEAE, as well as number of events.
Secondary Outcome Measures :
- Solicited TEAE [ Time Frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. ]Number and proportion of subjects with at least one solicited TEAE, as well as number of events.
- IMP-related AE [ Time Frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. ]Number and proportion of subjects with at least one IMP-related AE, as well as number of events.
- Treatment-emergent serious adverse events (SAE) [ Time Frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. ]Number and proportion of subjects with at least one treatment-emergent SAE, as well as number of events.
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| Ages Eligible for Study: | 12 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541004
Locations
Show 27 study locations
Sponsors and Collaborators
ALK-Abelló A/S
Syneos Health
Investigators
| Principal Investigator: | Andreas Horn, MD | HNO Praxis am Neckar |
| Responsible Party: | ALK-Abelló A/S |
| ClinicalTrials.gov Identifier: | NCT04541004 |
| Other Study ID Numbers: |
MT-18 2020-000446-34 ( EudraCT Number ) |
| First Posted: | September 9, 2020 Key Record Dates |
| Last Update Posted: | July 19, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by ALK-Abelló A/S:
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Allergic rhinitis House dust mite Adolescent Pediatric |
Additional relevant MeSH terms:
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Rhinitis Rhinitis, Allergic Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases |
Otorhinolaryngologic Diseases Hypersensitivity Immune System Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |