Clinical trial NCT04541004: Adolescent Mite Allergy Safety Evaluation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Allergic Rhinoconjunctivitis
Keywords: Allergic rhinitis
House dust mite
Adolescent
Pediatric
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2020-09-09
Enrollment: 253
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-armed
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Secondary outcomes:
measure: Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Number of Solicited Treatment-emergent Adverse Events (TEAEs)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Number of Subjects With at Least One IMP-related Adverse Event (AE)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Proportion of Subjects With at Least One IMP-related Adverse Event (AE)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Number of IMP-related Adverse Events (AEs)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
measure: Number of Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Other outcomes:
Locations:
city: Jablonec Nad Nisou
country: Czechia
facility: Alergopraktik s.r.o.
city: Jihlava
country: Czechia
facility: Allergology Jihlava
city: Kolín
country: Czechia
facility: Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a
city: Kutná Hora
country: Czechia
facility: Alergologicka ordinace
city: Litomyšl
country: Czechia
facility: Alergomyšl s.r.o.
city: Ostrava
country: Czechia
facility: Alergologie SKOPKOVA s.r.o.
city: Tábor
country: Czechia
facility: KASMED s.r.o.
city: Čáslav
country: Czechia
facility: Alergologicka ambulance
city: Heidelberg
country: Germany
facility: HNO Praxis am Neckar
state: Baden-Wrttemberg
city: Heidelberg
country: Germany
facility: Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
state: Baden-Wuerttemberg
city: Dreieich
country: Germany
facility: Praxis Dr. Decot
state: Hessen
city: Bramsche
country: Germany
facility: Kinderarztpraxis BramscheDr. Thomas Adelt
state: Niedersachsen
city: Wolmirstedt
country: Germany
facility: HNO-Genossenschaft Sachsen-Anhalt E.G.
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: HNO-Praxis Dr. med. Udo Schaefer
state: Sachsen
city: Dresden
country: Germany
facility: Facharzt fr HNO und Allergologie
state: Saxony
city: Banská Bystrica
country: Slovakia
facility: Ambulancia klinickej imunologie a alergologie
city: Bardejov
country: Slovakia
facility: ALIAN s.r.o.
city: Bratislava
country: Slovakia
facility: Jocia s.r.o.
city: Kezmarok
country: Slovakia
facility: AlergoImuno centrum s.r.o. - Ambulancia alergologi
city: Komárno
country: Slovakia
facility: ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie
city: Košice
country: Slovakia
facility: Alersa
city: Martin
country: Slovakia
facility: Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin
city: Poprad
country: Slovakia
facility: NZZ Imunologicka ambulancia
city: Prešov
country: Slovakia
facility: Alergo immunological center prešov
city: Rimavská Sobota
country: Slovakia
facility: Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o.
city: Trnava
country: Slovakia
facility: Medimun s.r.o.
city: Šurany
country: Slovakia
facility: Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie
Study officials:
affiliation: HNO Praxis am Neckar
name: Andreas Horn, MD
role: PRINCIPAL_INVESTIGATOR
References: