Adolescent Mite Allergy Safety Evaluation

NCT ID: NCT04541004

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2021-04-24

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.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HDM SLIT Tablet

House dust mite (HDM) Sublingual allergy immunotherapy tablet

Group Type: EXPERIMENTAL

HDM SLIT-tablet

Intervention Type: BIOLOGICAL

Sublingual allergy immunotherapy 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

Other Intervention Names

ACARIZAX, ODACTRA

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

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Horn, MD

Role: PRINCIPAL_INVESTIGATOR

HNO Praxis am Neckar

Locations

Alergologicka ambulance

Čáslav, , Czechia

Alergopraktik s.r.o.

Jablonec nad Nisou, , Czechia

Allergology Jihlava

Jihlava, , Czechia

Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a

Kolín, , Czechia

Alergologicka ordinace

Kutná Hora, , Czechia

Alergomyšl s.r.o.

Litomyšl, , Czechia

Alergologie SKOPKOVA s.r.o.

Ostrava, , Czechia

KASMED s.r.o.

Tábor, , Czechia

HNO Praxis am Neckar

Heidelberg, Baden-Wrttemberg, Germany

Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich

Heidelberg, Baden-Wurttemberg, Germany

Praxis Dr. Decot

Dreieich, Hesse, Germany

Kinderarztpraxis BramscheDr. Thomas Adelt

Bramsche, Lower Saxony, Germany

HNO-Praxis Dr. med. Udo Schaefer

Dresden, Saxony, Germany

Facharzt fr HNO und Allergologie

Dresden, Saxony, Germany

HNO-Genossenschaft Sachsen-Anhalt E.G.

Wolmirstedt, Saxony-Anhalt, Germany

Ambulancia klinickej imunologie a alergologie

Banská Bystrica, , Slovakia

ALIAN s.r.o.

Bardejov, , Slovakia

Jocia s.r.o.

Bratislava, , Slovakia

AlergoImuno centrum s.r.o. - Ambulancia alergologi

Kežmarok, , Slovakia

ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie

Komárno, , Slovakia

Alersa

Košice, , Slovakia

Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin

Martin, , Slovakia

NZZ Imunologicka ambulancia

Poprad, , Slovakia

Alergo immunological center prešov

Prešov, , Slovakia

Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o.

Rimavská Sobota, , Slovakia

Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie

Šurany, , Slovakia

Medimun s.r.o.

Trnava, , Slovakia

Countries

Czechia; Germany; Slovakia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-000446-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MT-18

Identifier Type: -

Identifier Source: org_study_id