Mite Asthma Pediatric Immunotherapy Trial

NCT03654976 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: MT-112016-004363-39
• Study Type: interventional
• Target: 533
• Locations: 9 countries
• Sites: 64

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.

Conditions

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

Keywords

Allergic asthma, allergic rhinitis, HDM, pediatric

Outcome Measures

Primary Outcomes (1)

• Annualized Rate of Clinically Relevant Asthma Exacerbations

  The primary endpoint of the trial was the annualized rate of clinically relevant asthma exacerbations calculated as the number of exacerbations per year per participant during the efficacy evaluation period of 20 months. A clinically relevant asthma exacerbation had to be medically confirmed and was defined as asthma worsening leading to at least 1 of the following criteria: * Doubling of ICS dose compared to background treatment * Systemic corticosteroids for treatment of asthma symptoms for at least 3 days * Emergency room visit due to asthma, requiring systemic corticosteroids * Hospitalization for more than 12 hours due to asthma, requiring treatment with systemic corticosteroids The outcome measure (by treatment group) is an adjusted annualized rate of clinically relevant asthma exacerbations.

  Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)

Secondary Outcomes (5)

• Proportion of Days With Nocturnal Awakenings Due to Asthma Requiring SABA Rescue Medication

  Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)

• Proportions of Days With SABA Use

  Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)

• Percentage Predicted FEV1

  Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)

• Global Evaluation of Allergic Asthma as Having an Improved Outcome

  Assessment done at the end of trial visit (after 24-30 months of treatment)

• Global Evaluation of Allergic Rhinitis as Having an Improved Outcome

  Assessment done at the end of trial visit (after 24-30 months of treatment)

Other Outcomes (2)

• Allergic Rhinitis Symptoms

  The efficacy assessment period for the endpoint started 4 months after treatment initiation and lasted until the end of the trial or discontinuation of treatment (up to 24-30 months of treatment).

• Allergic Rhinitis Medication Use

  The efficacy assessment period for the endpoint started 4 months after treatment initiation and lasted until the end of the trial or discontinuation of treatment (up to 24-30 months of treatment).

Study Arms (2)

Active treatment

EXPERIMENTAL

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

Biological: HDM SLIT-tablet

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

HDM SLIT-tablet BIOLOGICAL

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

Also known as: Acarizax, Odactra

Active treatment

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (64)

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Respiratory Medicine Research Institute of MI

Ypsilanti, Michigan, 48197, United States

Location

Private Clinic

Bangor, Pennsylvania, 04401, United States

Location

Allergy Consultants

Verona, Pennsylvania, 07044, United States

Location

TTS research

Boerne, Texas, 78006, United States

Location

STAAMP Research

San Antonio, Texas, 78251, United States

Location

MHAT

Plovdiv, Bulgaria

Location

UMBAL "St. Georgy"

Plovdiv, Bulgaria

Location

SHATPPD

Rousse, Bulgaria

Location

Medical Center-1-Sevlievo EOOD

Sevlievo, Bulgaria

Location

Alitera-Med-Medical Center EOOD

Sofia, Bulgaria

Location

MBAL Tokuda Hospital Sofia

Sofia, Bulgaria

Location

Medical Center Excelsior

Sofia, Bulgaria

Location

DCC Ritam 2010

Stara Zagora, Bulgaria

Location

Hopital Augustin Morvan

Brest, France

Location

Centre Hospitalier Universitaire de Caen

Caen, France

Location

Centre hospitalier intercommunal

Créteil, France

Location

Hôpital Jeanne de Flandre

Lille, France

Location

Groupe hospitalier Armand Trousseau - La Roche Guyon

Paris, France

Location

Kinderarzt-Praxis Bramsche

Bramsche, Germany

Location

Kinderarztpraxis Ludwigsfelde

Ludwigsfelde, Germany

Location

Kinderarztpraxis

Wuppertal, Germany

Location

Bajai Szent Rókus Kórház

Baja, Hungary

Location

Heim Pal Children's Hospital

Budapest, Hungary

Location

Semmelweis Egyetem

Budapest, Hungary

Location

Kanizsai Dorottya Korhaz

Nagykanizsa, Hungary

Location

Szent István Rendelő és Patika

Ráckeve, Hungary

Location

Aranyklinika Kft

Szeged, Hungary

Location

NZOZ E-Vita

Bialystok, Poland

Location

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, Poland

Location

Specjalistyczna Praktyka Lekarska

Katowice, Poland

Location

Centrum Medyczne PROMED

Krakow, Poland

Location

Centrum Nowoczesnych Terapii

Krakow, Poland

Location

WWCOiT

Lodz, Poland

Location

ALERGOTEST s.c. Specjalistyczne Centrum Medyczne

Lublin, Poland

Location

Uniwersytecki Szpital Dzieciecy w Lublinie

Lublin, Poland

Location

Ostrowieckie Centrum Medyczne S.C.

Ostrowiec Świętokrzyski, Poland

Location

Prywatny Gabinet Lekarski

Rzeszów, Poland

Location

NSZOZ Puls

Skarżysko-Kamienna, Poland

Location

ETG Skierniewice

Skierniewice, Poland

Location

ALERGO-MED Specjalistyczna

Tarnów, Poland

Location

Dobrostan

Wroclaw, Poland

Location

Specjalist.

Zabrze, Poland

Location

Kazan State Medical University 138

Kazan', Russia

Location

First Moscow State Medical University

Moscow, Russia

Location

Clinical and Diagnostic Centre "Zdorovie"

Rostov-on-Don, Russia

Location

Rayzan Regional Children Hospital

Ryazan, Russia

Location

City children's polyclinic #35

Saint Petersburg, Russia

Location

GBUZ "Children Municipal Polyclinic #45"

Saint Petersburg, Russia

Location

LLC ArsVite Severo-Zapad

Saint Petersburg, Russia

Location

LLC Kurator

Saint Petersburg, Russia

Location

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

Samara, Russia

Location

LLC 'ArsVitae Samara'

Samara, Russia

Location

Siberian State Medical University

Tomsk, Russia

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital Universitario Vall d'Hebrón

Barcelona, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, Spain

Location

Hospital de Sagunto

Sagunto, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Hospital de Conxo

Santiago de Compostela, Spain

Location

Hospital de la Plana

Villarreal, Spain

Location

Royal Manchester Children's Hospital - Paediatrics Oxford Road

Manchester, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Related Publications (1)

• 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 Dec;80(12):3401-3411. doi: 10.1111/all.70073. Epub 2025 Oct 9.

  PMID: 41064908 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Enrollment was paused at the outbreak of the COVID-19 pandemic. During the COVID-19 pandemic the asthma exacerbation rate decreased both in the trial population (blinded data) and in the general asthma population. It was therefore deemed difficult to recruit participants based on a history of recent asthma exacerbations. The sponsor decided to end the trial with the completed participants on 10-Aug-2022 due to the severe impact of COVID-19.

Results Point of Contact

• Title: Senior Director Global Clinical Development
• Organization: ALK-Abelló A/S

clinicaltrials@alk.net

0045 45747576

Study Officials

• Graham Roberts, MD

  University Hospital Southampton NHS Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel-group

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 31, 2018
• Study Start: February 22, 2018
• Primary Completion: May 18, 2022
• Study Completion: May 31, 2022
• Last Updated: October 19, 2023
• Results First Posted: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BU (8); DE (3); ES (7); US (7); HU (6); GB (2); FR (5); RU (11); PL (15)