Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
NCT ID: NCT02443805
Last Updated: 2019-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1607 participants
INTERVENTIONAL
2015-09-29
2018-06-25
Brief Summary
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Detailed Description
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The primary objective was to assess the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated AR. The primary efficacy variable was the average Total Combined Score.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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300 IR
300 IR tablet of HDM Allergen Extracts
300 IR
300 IR tablet of HDM Allergen Extracts
Placebo
Placebo tablet
Placebo
Placebo tablet
Interventions
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300 IR
300 IR tablet of HDM Allergen Extracts
Placebo
Placebo tablet
Eligibility Criteria
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Inclusion Criteria
* Patients sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined on skin prick test and HDM-specific serum IgE
Exclusion Criteria
* Partly controlled or uncontrolled asthma
* Controlled asthma requiring controller treatment(s) consistent with GINA 2014 treatment Steps 3 to 5
12 Years
65 Years
ALL
No
Sponsors
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Stallergenes Greer
INDUSTRY
Responsible Party
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Principal Investigators
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Pascal Demoly, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Arnaud de Villeneuve, Montpellier, France
Tom Casale, MD
Role: PRINCIPAL_INVESTIGATOR
University of South of Florida, Tampa, USA
Locations
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University of South of Florida
Tampa, Florida, United States
CHU Arnaud de Villeneuve
Montpellier, , France
Countries
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References
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Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.
Pfaar O, De Blay F, Canonica GW, Casale TB, Gevaert P, Hellings PW, Kowal K, Passalacqua G, Tortajada-Girbes M, Vidal C, Worm M, Bahbah F, Demoly P. Clinical benefits with 300 IR HDM SLIT tablet in Europeans with house dust mite allergic rhinitis: Post hoc analysis of a large phase 3 trial. World Allergy Organ J. 2023 Dec 22;17(1):100849. doi: 10.1016/j.waojou.2023.100849. eCollection 2024 Jan.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SL75.14
Identifier Type: -
Identifier Source: org_study_id
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