Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents
Investigation of the Safety and Tolerability of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents With House Dust Mite-associated Allergic Rhinitis
1 other identifier
interventional
37
1 country
1
Brief Summary
The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 2, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
January 17, 2025
CompletedJanuary 17, 2025
December 1, 2015
2 months
August 2, 2013
November 27, 2024
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
10 dosing treatment days
Secondary Outcomes (2)
Treatment Emergent Serious Adverse Events
10 dosing treatment days
Adverse Events Leading to Study Withdrawal
10 dosing treatment days
Study Arms (4)
500 IR
EXPERIMENTAL500 IR house dust mites allergen extract tablet
1000 IR
EXPERIMENTAL1000 IR house dust mites allergen extract tablet
1500 IR
EXPERIMENTAL1500 IR house dust mites allergen extract tablet
Placebo
PLACEBO COMPARATORPlacebo tablet
Interventions
One sublingual tablet daily during 10 days
Two sublingual tablets daily during 10 days
Three sublingual tablets daily during 10 days
One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
Eligibility Criteria
You may qualify if:
- Written informed consent from patient and parent(s)/legal representative.
- Male or female patient from 12 to 17 years.
- Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
- Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
- Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
- Spirometry with best FEV1 \> 80% of predicted FEV1.
You may not qualify if:
- Patient with a nasal or oral disease that could interfere with the safety assessments
- Patient has undergone recent nasal surgery
- Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
- Patient with partially controlled or uncontrolled asthma
- Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
- Female patient pregnant or breast-feeding/lactating.
- Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
- Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
- patient with a history of anaphylaxis
- patient having participated in any clinical study within the 12 weeks before visit 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stallergenes Greerlead
- Syneos Healthcollaborator
Study Sites (1)
Inflamax Research Inc.
Mississauga, Ontario, L4W 1N2, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michel Roux, Medical Director
- Organization
- Stallergenes
Study Officials
- PRINCIPAL INVESTIGATOR
Piyush Patel, MD
Inflamax Research Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2013
First Posted
August 9, 2013
Study Start
July 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
January 17, 2025
Results First Posted
January 17, 2025
Record last verified: 2015-12