Adolescent Mite Allergy Safety Evaluation

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

Sponsors

Lead Sponsor: ALK-Abelló A/S

Collaborator: Syneos Health

Source ALK-Abelló A/S
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.

Overall Status Not yet recruiting
Start Date September 2020
Completion Date March 2021
Primary Completion Date March 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Treatment-emergent adverse event (TEAE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Secondary Outcome
Measure Time Frame
Solicited TEAE From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
IMP-related AE From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Treatment-emergent serious adverse events (SAE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Enrollment 250
Condition
Intervention

Intervention Type: Biological

Intervention Name: HDM SLIT-tablet

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

Arm Group Label: HDM SLIT Tablet

Other Name: 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 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

Gender: All

Minimum Age: 12 Years

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Andreas Horn, MD Principal Investigator HNO Praxis am Neckar
Overall Contact

Last Name: Clinical Project Manager

Phone: +45 45747576

Email: [email protected]

Location
Facility:
Hornmed s.r.o. Alergologie a Imunologie - Hornmed s.r.o. | Brno, 61800, Czechia
FN Brno | Brno, 62500, Czechia Ondrej Rybnicek, MD
Alergopraktik s.r.o. | Jablonec Nad Nisou, 46601, Czechia Marie Mattauchova, MD
Allergology Jihlava | Jihlava, 58601, Czechia Tomas Hofstetr, MD
Alergologicka ordinace | Kutná Hora, 28401, Czechia Hana Smrckova, MD
Alergomyšl s.r.o. | Litomyšl, 57014, Czechia Vlasta Dunajová, MD
Alergologie SKOPKOVA s.r.o. | Ostrava, 70900, Czechia Olga Skopkova, MD
KASMED s.r.o. | Tábor, 39002, Czechia Milan Kasl, MD
Alergologicka ambulance | Čáslav, 28601, Czechia Ivona Vondrakova, MD
HNO Praxis am Neckar | Heidelberg, Baden-Wrttemberg, 69120, Germany Andreas Horn, MD
Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich | Heidelberg, Baden-Wuerttemberg, 69126, Germany Florian Heimlich, MD
HNO Praxis r. Andrea Kienle-Gogolok | Bad Schönborn, Baden-Württemberg, 76669, Germany Andrea Kienle-Gogolok, MD
Praxis Dr. Decot | Dreieich, Hessen, 63303, Germany Elke Decot, MD
Kinderarztpraxis BramscheDr. Thomas Adelt | Bramsche, Niedersachsen, 49565, Germany Thomas Adelt, MD
HNO-Genossenschaft Sachsen-Anhalt E.G. | Wolmirstedt, Sachsen-Anhalt, 39326, Germany
HNO-Praxis Dr. med. Udo Schaefer | Dresden, Sachsen, 01067, Germany Udo Schäfer, MD
Facharzt fr HNO und Allergologie | Dresden, Saxony, 013999, Germany Yury Yarin, PhD
Ambulancia klinickej imunologie a alergologie | Banská Bystrica, 97405, Slovakia Eva Medzihorska, MD
ALIAN s.r.o. | Bardejov, 08501, Slovakia Mária Džupinová, MD
Jocia s.r.o. | Bratislava, 82108, Slovakia Jaroslava Orosova, MD
AlergoImuno centrum s.r.o. - Ambulancia alergologi | Kezmarok, 06001, Slovakia Ivan Hlinka, MD
ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie | Komárno, 94501, Slovakia Svetlana Hadvabová, MD
Alersa | Košice, 04022, Slovakia Daniela Safcakova, MD
Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin | Martin, 03659, Slovakia Jan Mikler, MD
NZZ Imunologicka ambulancia | Poprad, 05801, Slovakia Eva Lapšanská, MD
Alergo immunological center prešov | Prešov, 08001, Slovakia Slavka Belvoncikova, MD
Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o. | Rimavská Sobota, 901981, Slovakia Lobica Zollerova, MD
Medimun s.r.o. | Trnava, 91701, Slovakia Viera Karlubikova, MD
Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie | Šurany, 94201, Slovakia Iveta Hajdenova, MD
Location Countries

Czechia

Germany

Slovakia

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: HDM SLIT Tablet

Type: Experimental

Description: House dust mite (HDM) Sublingual allergy immunotherapy tablet

Acronym AMASE
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: single-armed

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: Non applicable

Source: ClinicalTrials.gov