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Completed

NCT Number: NCT04541004

Adolescent Mite Allergy Safety Evaluation

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.

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Key information

Conditions

Allergic Rhinitis Allergic Rhinoconjunctivitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alergopraktik s.r.o., Jablonec nad Nisou, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDM SLIT-tablet

Biological

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

Other names: ACARIZAX, ODACTRA

Primary outcomes

  1. Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

    Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

    At least one TEAE

  2. Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

    Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

    At least one TEAE

  3. Number of Treatment-emergent Adverse Events (TEAEs)

    Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

    At least one TEAE

Secondary outcomes

  1. Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)

    Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

    At least one solicited TEAE

  2. Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)

    Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

    At least one solicited TEAE

  3. Number of Solicited Treatment-emergent Adverse Events (TEAEs)

    Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.

    At least one solicited TEAE

  4. Number of Subjects With at Least One IMP-related Adverse Event (AE)

    Time frame: 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

  5. Proportion of Subjects With at Least One IMP-related Adverse Event (AE)

    Time frame: 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

  6. Number of IMP-related Adverse Events (AEs)

    Time frame: 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

  7. Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)

    Time frame: 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

  8. Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)

    Time frame: 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

  9. Number of Treatment-emergent Serious Adverse Events (SAEs)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Collaborators

  • Syneos Health

Registry information

Official study 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

Acronym: AMASE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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