Adolescent Mite Allergy Safety Evaluation

NCT04541004 | Completed Phase 3 Results

• 2 other identifiers: MT-182020-000446-34
• Study Type: interventional
• Target: 253
• Locations: 3 countries
• Sites: 27

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.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Keywords

Allergic rhinitis; House dust mite; Adolescent; Pediatric

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (9)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

HDM SLIT Tablet

EXPERIMENTAL

House dust mite (HDM) Sublingual allergy immunotherapy tablet

Biological: HDM SLIT-tablet

Interventions

HDM SLIT-tablet BIOLOGICAL

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

Also known as: ACARIZAX, ODACTRA

HDM SLIT Tablet

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead
• Syneos Health: collaborator

Study Sites (27)

Alergologicka ambulance

Čáslav, 28601, Czechia

Location

Alergopraktik s.r.o.

Jablonec nad Nisou, 46601, Czechia

Location

Allergology Jihlava

Jihlava, 58601, Czechia

Location

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

Kolín, Czechia

Location

Alergologicka ordinace

Kutná Hora, 28401, Czechia

Location

Alergomyšl s.r.o.

Litomyšl, 57014, Czechia

Location

Alergologie SKOPKOVA s.r.o.

Ostrava, 70900, Czechia

Location

KASMED s.r.o.

Tábor, 39002, Czechia

Location

HNO Praxis am Neckar

Heidelberg, Baden-Wrttemberg, 69120, Germany

Location

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

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Praxis Dr. Decot

Dreieich, Hesse, 63303, Germany

Location

Kinderarztpraxis BramscheDr. Thomas Adelt

Bramsche, Lower Saxony, 49565, Germany

Location

HNO-Praxis Dr. med. Udo Schaefer

Dresden, Saxony, 01067, Germany

Location

Facharzt fr HNO und Allergologie

Dresden, Saxony, 013999, Germany

Location

HNO-Genossenschaft Sachsen-Anhalt E.G.

Wolmirstedt, Saxony-Anhalt, 39326, Germany

Location

Ambulancia klinickej imunologie a alergologie

Banská Bystrica, 97405, Slovakia

Location

ALIAN s.r.o.

Bardejov, 08501, Slovakia

Location

Jocia s.r.o.

Bratislava, 82108, Slovakia

Location

AlergoImuno centrum s.r.o. - Ambulancia alergologi

Kežmarok, 06001, Slovakia

Location

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

Komárno, 94501, Slovakia

Location

Alersa

Košice, 04022, Slovakia

Location

Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin

Martin, 03659, Slovakia

Location

NZZ Imunologicka ambulancia

Poprad, 05801, Slovakia

Location

Alergo immunological center prešov

Prešov, 08001, Slovakia

Location

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

Rimavská Sobota, 901981, Slovakia

Location

Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie

Šurany, 94201, Slovakia

Location

Medimun s.r.o.

Trnava, 91701, Slovakia

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: David Hal Mollerup, Senior Director
• Organization: ALK-Abelló A/S

ClinicalTrials@alk.net

+45 45747576

Study Officials

• Andreas Horn, MD

  HNO Praxis am Neckar

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Non applicable
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-armed

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: September 23, 2020
• Primary Completion: April 24, 2021
• Study Completion: April 24, 2021
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (8); DE (7); SL (12)