Adolescent Mite Allergy Safety Evaluation (AMASE)

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Allergic Rhinoconjunctivitis
• Intervention / Treatment: Biological: HDM SLIT-tablet

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 Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Jablonec Nad Nisou, Czechia, 46601
    • Alergopraktik s.r.o.
  • Jihlava, Czechia, 58601
    • Allergology Jihlava
  • Kolín, Czechia
    • Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a
  • Kutná Hora, Czechia, 28401
    • Alergologicka ordinace
  • Litomyšl, Czechia, 57014
    • Alergomyšl s.r.o.
  • Ostrava, Czechia, 70900
    • Alergologie SKOPKOVA s.r.o.
  • Tábor, Czechia, 39002
    • KASMED s.r.o.
  • Čáslav, Czechia, 28601
    • Alergologicka ambulance
• Germany
  • Baden-Wrttemberg
    • Heidelberg, Baden-Wrttemberg, Germany, 69120
      • HNO Praxis am Neckar
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69126
      • Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
  • Hessen
    • Dreieich, Hessen, Germany, 63303
      • Praxis Dr. Decot
  • Niedersachsen
    • Bramsche, Niedersachsen, Germany, 49565
      • Kinderarztpraxis BramscheDr. Thomas Adelt
  • Sachsen
    • Dresden, Sachsen, Germany, 01067
      • HNO-Praxis Dr. med. Udo Schaefer
  • Sachsen-Anhalt
    • Wolmirstedt, Sachsen-Anhalt, Germany, 39326
      • HNO-Genossenschaft Sachsen-Anhalt E.G.
  • Saxony
    • Dresden, Saxony, Germany, 013999
      • Facharzt fr HNO und Allergologie
• Slovakia
  • Banská Bystrica, Slovakia, 97405
    • Ambulancia klinickej imunologie a alergologie
  • Bardejov, Slovakia, 08501
    • ALIAN s.r.o.
  • Bratislava, Slovakia, 82108
    • Jocia s.r.o.
  • Kezmarok, Slovakia, 06001
    • AlergoImuno centrum s.r.o. - Ambulancia alergologi
  • Komárno, Slovakia, 94501
    • ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie
  • Košice, Slovakia, 04022
    • Alersa
  • Martin, Slovakia, 03659
    • Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin
  • Poprad, Slovakia, 05801
    • NZZ Imunologicka ambulancia
  • Prešov, Slovakia, 08001
    • Alergo immunological center prešov
  • Rimavská Sobota, Slovakia, 901981
    • Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o.
  • Trnava, Slovakia, 91701
    • Medimun s.r.o.
  • Šurany, Slovakia, 94201
    • Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HDM SLIT Tablet; House dust mite (HDM) Sublingual allergy immunotherapy tablet	Biological: HDM SLIT-tablet; Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day); Other Names: ACARIZAX, ODACTRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)	At least one TEAE	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	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	From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)	At least one solicited TEAE	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	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	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	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	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	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	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	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	From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Collaborators: Syneos Health
• Investigators: Principal Investigator: Andreas Horn, MD, HNO Praxis am Neckar

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): April 24, 2021
• Study Completion (Actual): April 24, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Adolescent; Pediatric; Allergic rhinitis; House dust mite
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: MT-18; 2020-000446-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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