Adolescent Mite Allergy Safety Evaluation
- Conditions
- Allergic RhinitisAllergic Rhinoconjunctivitis
- Interventions
- Biological: HDM SLIT-tablet
- Registration Number
- NCT04541004
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 253
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HDM SLIT Tablet HDM SLIT-tablet House dust mite (HDM) Sublingual allergy immunotherapy tablet
- Primary Outcome Measures
Name Time Method Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one TEAE
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one TEAE
Number of Treatment-emergent Adverse Events (TEAEs) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one TEAE
- Secondary Outcome Measures
Name Time Method Number of IMP-related Adverse Events (AEs) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one IMP-related AE
Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one treatment-emergent SAE
Proportion of Subjects With at Least One IMP-related Adverse Event (AE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one IMP-related AE
Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one solicited TEAE
Number of Solicited Treatment-emergent Adverse Events (TEAEs) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one solicited TEAE
Number of Subjects With at Least One IMP-related Adverse Event (AE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one IMP-related AE
Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one treatment-emergent SAE
Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one solicited TEAE
Number of Treatment-emergent Serious Adverse Events (SAEs) From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. At least one treatment-emergent SAE
Trial Locations
- Locations (27)
NZZ Imunologicka ambulancia
🇸🇰Poprad, Slovakia
Alergopraktik s.r.o.
🇨🇿Jablonec Nad Nisou, Czechia
Medimun s.r.o.
🇸🇰Trnava, Slovakia
Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a
🇨🇿Kolín, Czechia
Alergologicka ordinace
🇨🇿Kutná Hora, Czechia
Allergology Jihlava
🇨🇿Jihlava, Czechia
Alergomyšl s.r.o.
🇨🇿Litomyšl, Czechia
KASMED s.r.o.
🇨🇿Tábor, Czechia
Alergologie SKOPKOVA s.r.o.
🇨🇿Ostrava, Czechia
Alergologicka ambulance
🇨🇿Čáslav, Czechia
HNO Praxis am Neckar
🇩🇪Heidelberg, Baden-Wrttemberg, Germany
Kinderarztpraxis BramscheDr. Thomas Adelt
🇩🇪Bramsche, Niedersachsen, Germany
Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Praxis Dr. Decot
🇩🇪Dreieich, Hessen, Germany
AlergoImuno centrum s.r.o. - Ambulancia alergologi
🇸🇰Kezmarok, Slovakia
Jocia s.r.o.
🇸🇰Bratislava, Slovakia
ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie
🇸🇰Komárno, Slovakia
HNO-Genossenschaft Sachsen-Anhalt E.G.
🇩🇪Wolmirstedt, Sachsen-Anhalt, Germany
HNO-Praxis Dr. med. Udo Schaefer
🇩🇪Dresden, Sachsen, Germany
ALIAN s.r.o.
🇸🇰Bardejov, Slovakia
Ambulancia klinickej imunologie a alergologie
🇸🇰Banská Bystrica, Slovakia
Facharzt fr HNO und Allergologie
🇩🇪Dresden, Saxony, Germany
Alergo immunological center prešov
🇸🇰Prešov, Slovakia
Alersa
🇸🇰Košice, Slovakia
Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o.
🇸🇰Rimavská Sobota, Slovakia
Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie
🇸🇰Šurany, Slovakia