search
Back to results

Adolescent Mite Allergy Safety Evaluation (AMASE)

Primary Purpose

Allergic Rhinitis, Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HDM SLIT-tablet
Sponsored by
ALK-Abelló A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic rhinitis, House dust mite, Adolescent, Pediatric

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alergopraktik s.r.o.
  • Allergology Jihlava
  • Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a
  • Alergologicka ordinace
  • Alergomyšl s.r.o.
  • Alergologie SKOPKOVA s.r.o.
  • KASMED s.r.o.
  • Alergologicka ambulance
  • HNO Praxis am Neckar
  • Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
  • Praxis Dr. Decot
  • Kinderarztpraxis BramscheDr. Thomas Adelt
  • HNO-Genossenschaft Sachsen-Anhalt E.G.
  • HNO-Praxis Dr. med. Udo Schaefer
  • Facharzt fr HNO und Allergologie
  • Ambulancia klinickej imunologie a alergologie
  • ALIAN s.r.o.
  • Jocia s.r.o.
  • AlergoImuno centrum s.r.o. - Ambulancia alergologi
  • ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie
  • Alersa
  • Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin
  • NZZ Imunologicka ambulancia
  • Alergo immunological center prešov
  • Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o.
  • Medimun s.r.o.
  • Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HDM SLIT Tablet

Arm Description

House dust mite (HDM) Sublingual allergy immunotherapy tablet

Outcomes

Primary Outcome Measures

Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
At least one TEAE
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
At least one TEAE
Number of Treatment-emergent Adverse Events (TEAEs)
At least one TEAE

Secondary Outcome Measures

Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
At least one solicited TEAE
Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
At least one solicited TEAE
Number of Solicited Treatment-emergent Adverse Events (TEAEs)
At least one solicited TEAE
Number of Subjects With at Least One IMP-related Adverse Event (AE)
At least one IMP-related AE
Proportion of Subjects With at Least One IMP-related Adverse Event (AE)
At least one IMP-related AE
Number of IMP-related Adverse Events (AEs)
At least one IMP-related AE
Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
At least one treatment-emergent SAE
Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
At least one treatment-emergent SAE
Number of Treatment-emergent Serious Adverse Events (SAEs)
At least one treatment-emergent SAE

Full Information

First Posted
September 1, 2020
Last Updated
July 26, 2022
Sponsor
ALK-Abelló A/S
Collaborators
Syneos Health
search

1. Study Identification

Unique Protocol Identification Number
NCT04541004
Brief Title
Adolescent Mite Allergy Safety Evaluation
Acronym
AMASE
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
April 24, 2021 (Actual)
Study Completion Date
April 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
Collaborators
Syneos Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Keywords
Allergic rhinitis, House dust mite, Adolescent, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
single-armed
Masking
None (Open Label)
Masking Description
Non applicable
Allocation
N/A
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HDM SLIT Tablet
Arm Type
Experimental
Arm Description
House dust mite (HDM) Sublingual allergy immunotherapy tablet
Intervention Type
Biological
Intervention Name(s)
HDM SLIT-tablet
Other Intervention Name(s)
ACARIZAX, ODACTRA
Intervention Description
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Primary Outcome Measure Information:
Title
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
Description
At least one TEAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
Description
At least one TEAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Number of Treatment-emergent Adverse Events (TEAEs)
Description
At least one TEAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Secondary Outcome Measure Information:
Title
Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
Description
At least one solicited TEAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
Description
At least one solicited TEAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Number of Solicited Treatment-emergent Adverse Events (TEAEs)
Description
At least one solicited TEAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Number of Subjects With at Least One IMP-related Adverse Event (AE)
Description
At least one IMP-related AE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Proportion of Subjects With at Least One IMP-related Adverse Event (AE)
Description
At least one IMP-related AE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Number of IMP-related Adverse Events (AEs)
Description
At least one IMP-related AE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
Description
At least one treatment-emergent SAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
Description
At least one treatment-emergent SAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Title
Number of Treatment-emergent Serious Adverse Events (SAEs)
Description
At least one treatment-emergent SAE
Time Frame
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Horn, MD
Organizational Affiliation
HNO Praxis am Neckar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alergopraktik s.r.o.
City
Jablonec Nad Nisou
ZIP/Postal Code
46601
Country
Czechia
Facility Name
Allergology Jihlava
City
Jihlava
ZIP/Postal Code
58601
Country
Czechia
Facility Name
Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a
City
Kolín
Country
Czechia
Facility Name
Alergologicka ordinace
City
Kutná Hora
ZIP/Postal Code
28401
Country
Czechia
Facility Name
Alergomyšl s.r.o.
City
Litomyšl
ZIP/Postal Code
57014
Country
Czechia
Facility Name
Alergologie SKOPKOVA s.r.o.
City
Ostrava
ZIP/Postal Code
70900
Country
Czechia
Facility Name
KASMED s.r.o.
City
Tábor
ZIP/Postal Code
39002
Country
Czechia
Facility Name
Alergologicka ambulance
City
Čáslav
ZIP/Postal Code
28601
Country
Czechia
Facility Name
HNO Praxis am Neckar
City
Heidelberg
State/Province
Baden-Wrttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Praxis Dr. Decot
City
Dreieich
State/Province
Hessen
ZIP/Postal Code
63303
Country
Germany
Facility Name
Kinderarztpraxis BramscheDr. Thomas Adelt
City
Bramsche
State/Province
Niedersachsen
ZIP/Postal Code
49565
Country
Germany
Facility Name
HNO-Genossenschaft Sachsen-Anhalt E.G.
City
Wolmirstedt
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39326
Country
Germany
Facility Name
HNO-Praxis Dr. med. Udo Schaefer
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
Facharzt fr HNO und Allergologie
City
Dresden
State/Province
Saxony
ZIP/Postal Code
013999
Country
Germany
Facility Name
Ambulancia klinickej imunologie a alergologie
City
Banská Bystrica
ZIP/Postal Code
97405
Country
Slovakia
Facility Name
ALIAN s.r.o.
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Jocia s.r.o.
City
Bratislava
ZIP/Postal Code
82108
Country
Slovakia
Facility Name
AlergoImuno centrum s.r.o. - Ambulancia alergologi
City
Kezmarok
ZIP/Postal Code
06001
Country
Slovakia
Facility Name
ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie
City
Komárno
ZIP/Postal Code
94501
Country
Slovakia
Facility Name
Alersa
City
Košice
ZIP/Postal Code
04022
Country
Slovakia
Facility Name
Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
NZZ Imunologicka ambulancia
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Facility Name
Alergo immunological center prešov
City
Prešov
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o.
City
Rimavská Sobota
ZIP/Postal Code
901981
Country
Slovakia
Facility Name
Medimun s.r.o.
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie
City
Šurany
ZIP/Postal Code
94201
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adolescent Mite Allergy Safety Evaluation

We'll reach out to this number within 24 hrs