Mite Asthma Pediatric Immunotherapy Trial

NCT ID: NCT03654976

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 533 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2022-05-31

Brief Summary

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.

Detailed Description

The trial aims to demonstrate efficacy of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations.

Additionally, the trial will investigate if the treatment has an effect on asthma symptoms including nightly awakenings due to asthma, asthma medication use, asthma control, lung function, allergic rhinitis and allergic rhinoconjunctivitis.

Finally, quality of life (QoL) for subjects and caregivers will be measured.

The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 2 years. Subjects will receive a written asthma action plan.

Conditions

Allergic Asthma Due to Dermatophagoides Farinae; Allergic Asthma Due to Dermatophagoides Pteronyssinus; Allergic Rhinitis Due to House Dust Mite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active treatment

Subject's ICS or ICS/LABA background medication plus HDM SLIT-tablet

Group Type: EXPERIMENTAL

HDM SLIT-tablet

Intervention Type: BIOLOGICAL

Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)

Placebo

Subject's ICS or ICS/LABA background medication plus placebo oral tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo sublingual tablet, for daily administration (1 tablet per day)

Interventions

HDM SLIT-tablet

Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)

Intervention Type: BIOLOGICAL

Placebo

Placebo sublingual tablet, for daily administration (1 tablet per day)

Intervention Type: OTHER

Other Intervention Names

Acarizax; Odactra

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Male or female of any race/ethnicity aged 5-17 years
• A female subject of childbearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods
• A clinical history of HDM allergic asthma
• Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with or without LABA for the control of asthma symptoms
• A clinical history of asthma exacerbations in the past two years
• One or more of the following within the past 4 weeks prior to randomisation:

• Daytime asthma symptoms more than twice/week
• Any nocturnal awakening due to asthma
• SABA rescue medication needed for treatment of asthma symptoms
• Any activity limitation due to asthma
• Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements
• Clinical history of HDM AR within the last year prior to randomisation
• An average TCRS>0 during the baseline period
• Positive specific IgE (defined as ≥class 2, ≥0.70 kU/l) against D. pteronyssinus and/or D. farinae at screening
• Positive SPT to D. pteronyssinus and/or D. farinae at screening
• Subject willing and able to comply with trial protocol

Exclusion Criteria

• Is sensitised and regularly exposed to animal dander, molds, and/or cockroach or other perennial allergen
• Has experienced a life-threatening asthma attack
• Within the last month before the randomisation visit (visit 3), has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
• Within the last 3 months before the randomisation visit (visit 3) while on high dose ICS treatment, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
• Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
• Ongoing treatment with any allergy immunotherapy product
• Any clinically relevant condition or chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
• Has a diagnosis of eosinophilic oesophagitis
• A relevant history of systemic allergic reactions
• Ongoing treatment with OCS
• Treatment with restricted and prohibited concomitant medication
• Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
• A history of allergy, hypersensitivity or intolerance to any of the excipients or active substance of the IMP (except D. pteronyssinus and D. farinae) or to any excipient of the rescue medication provided in this trial
• A business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
• A history of alcohol or drug abuse
• Has previously been randomised into this trial, is participating in this trial at another investigational site or is participating or planning to participate in any other clinical trial during the duration of this trial
• Has a history or current evidence of any condition, treatment, laboratory values out of range or other circumstance that in the opinion of the investigator are clinically relevant and might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial
• Has a condition or treatment that increase the risk of the subject developing severe adverse reactions after adrenaline/epinephrine administration
• Is unable to or will not comply with the use of adrenaline/epinephrine auto-injectors for countries where this is a regulatory requirement

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graham Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation

Locations

Miami Clinical Research

Miami, Florida, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

Respiratory Medicine Research Institute of MI

Ypsilanti, Michigan, United States

Private Clinic

Bangor, Pennsylvania, United States

Allergy Consultants

Verona, Pennsylvania, United States

TTS research

Boerne, Texas, United States

STAAMP Research

San Antonio, Texas, United States

MHAT

Plovdiv, , Bulgaria

UMBAL "St. Georgy"

Plovdiv, , Bulgaria

SHATPPD

Rousse, , Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, , Bulgaria

Alitera-Med-Medical Center EOOD

Sofia, , Bulgaria

MBAL Tokuda Hospital Sofia

Sofia, , Bulgaria

Medical Center Excelsior

Sofia, , Bulgaria

DCC Ritam 2010

Stara Zagora, , Bulgaria

Hopital Augustin Morvan

Brest, , France

Centre Hospitalier Universitaire de Caen

Caen, , France

Centre hospitalier intercommunal

Créteil, , France

Hôpital Jeanne de Flandre

Lille, , France

Groupe hospitalier Armand Trousseau - La Roche Guyon

Paris, , France

Kinderarzt-Praxis Bramsche

Bramsche, , Germany

Kinderarztpraxis Ludwigsfelde

Ludwigsfelde, , Germany

Kinderarztpraxis

Wuppertal, , Germany

Bajai Szent Rókus Kórház

Baja, , Hungary

Heim Pal Children's Hospital

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Kanizsai Dorottya Korhaz

Nagykanizsa, , Hungary

Szent István Rendelő és Patika

Ráckeve, , Hungary

Aranyklinika Kft

Szeged, , Hungary

NZOZ E-Vita

Bialystok, , Poland

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, , Poland

Specjalistyczna Praktyka Lekarska

Katowice, , Poland

Centrum Medyczne PROMED

Krakow, , Poland

Centrum Nowoczesnych Terapii

Krakow, , Poland

WWCOiT

Lodz, , Poland

ALERGOTEST s.c. Specjalistyczne Centrum Medyczne

Lublin, , Poland

Uniwersytecki Szpital Dzieciecy w Lublinie

Lublin, , Poland

Ostrowieckie Centrum Medyczne S.C.

Ostrowiec Świętokrzyski, , Poland

Prywatny Gabinet Lekarski

Rzeszów, , Poland

NSZOZ Puls

Skarżysko-Kamienna, , Poland

ETG Skierniewice

Skierniewice, , Poland

ALERGO-MED Specjalistyczna

Tarnów, , Poland

Dobrostan

Wroclaw, , Poland

Specjalist.

Zabrze, , Poland

Kazan State Medical University 138

Kazan', , Russia

First Moscow State Medical University

Moscow, , Russia

Clinical and Diagnostic Centre "Zdorovie"

Rostov-on-Don, , Russia

Rayzan Regional Children Hospital

Ryazan, , Russia

City children's polyclinic #35

Saint Petersburg, , Russia

GBUZ "Children Municipal Polyclinic #45"

Saint Petersburg, , Russia

LLC ArsVite Severo-Zapad

Saint Petersburg, , Russia

LLC Kurator

Saint Petersburg, , Russia

GBUZ "Samarskiy oblastnoy detskiy sanatoriy "Yunost" 9-proseka

Samara, , Russia

LLC 'ArsVitae Samara'

Samara, , Russia

Siberian State Medical University

Tomsk, , Russia

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Hospital Universitario Vall d'Hebrón

Barcelona, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital de Sagunto

Sagunto, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Hospital de Conxo

Santiago de Compostela, , Spain

Hospital de la Plana

Villarreal, , Spain

Royal Manchester Children's Hospital - Paediatrics Oxford Road

Manchester, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Countries

United States; Bulgaria; France; Germany; Hungary; Poland; Russia; Spain; United Kingdom

References

Roberts G, Just J, Nolte H, Hels OH, Emeryk A, Vidal C. SQ House Dust Mite Sublingual Immunotherapy Tablet in Children With Allergic Asthma: A Randomised Phase III Trial. Allergy. 2025 Oct 9. doi: 10.1111/all.70073. Online ahead of print.

Reference Type: DERIVED

PMID: 41064908 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-004363-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MT-11

Identifier Type: -

Identifier Source: org_study_id