Adolescent Mite Allergy Safety Evaluation

Allergic Rhinitis Clinical Trial

— AMASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541004
• Other study ID #: MT-18
• Secondary ID: 2020-000446-34
• Status: Completed
• Phase: Phase 3
• Start date: September 23, 2020
• Est. completion date: April 24, 2021

Study information

• Verified date: July 2022
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: April 24, 2021
• Est. primary completion date: April 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• HDM SLIT-tablet
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)

Locations

Country	Name	City	State
Czechia	Alergologicka ambulance	Cáslav
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
Germany	Kinderarztpraxis BramscheDr. Thomas Adelt	Bramsche	Niedersachsen
Germany	Praxis Dr. Decot	Dreieich	Hessen
Germany	Facharzt fr HNO und Allergologie	Dresden	Saxony
Germany	HNO-Praxis Dr. med. Udo Schaefer	Dresden	Sachsen
Germany	HNO Praxis am Neckar	Heidelberg	Baden-Wrttemberg
Germany	Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich	Heidelberg	Baden-Wuerttemberg
Germany	HNO-Genossenschaft Sachsen-Anhalt E.G.	Wolmirstedt	Sachsen-Anhalt
Slovakia	Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie	Šurany
Slovakia	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	Kezmarok
Slovakia	Alersa	Košice
Slovakia	ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie	Komárno
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	Medimun s.r.o.	Trnava

Sponsors (2)

Lead Sponsor	Collaborator
ALK-Abelló A/S	Syneos Health

Countries where clinical trial is conducted

Czechia,  Germany,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.