Rhinitis, Allergic, PerennialPhase 3NCT02443805
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
A Phase 3 study testing 300 IR in people with Rhinitis, Allergic, Perennial and House Dust Mite Allergy, run by Stallergenes Greer at 2 sites in 2 countries.
Trial summary
The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial, House Dust Mite Allergy
- What is being tested?
- 300 IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,607 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Sep 2015to 25 Jun 2018
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
- Patients with HDM-associated allergic rhinitis (AR) for at least 1 year
- Patients sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined on skin prick test and HDM-specific serum IgE
Main Exclusion Criteria:
- A history of rhinitis, rhinoconjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the evaluation periods
- Partly controlled or uncontrolled asthma
- Controlled asthma requiring controller treatment(s) consistent with GINA 2014 treatment Steps 3 to 5
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of South of Florida
Tampa, Florida, 33610
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Efficacy and Safety of STG320 Sublingual Tablets of House Dust Mite (HDM) Allergen Extracts in Adults and Adolescents With HDM-associated Allergic Rhinitis
The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.
Read the detailed description
This study was a randomized, double-blind, placebo-controlled, phase III study with 2 parallel arms in adults and adolescents with HDM-associated allergic rhinitis (AR) for at least one year.
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.
- Being tested
- 300 IR, Placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 IRBiological
300 IR tablet of HDM Allergen Extracts
PlaceboBiological
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 300 IR | Active comparator | 300 IR tablet of HDM Allergen Extracts Receives: Biological: 300 IR |
| Placebo | Placebo comparator | Placebo tablet Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Combined Score
Average Total Combined Score (TCS), calculated for each patient as the average of the non-missing daily TCSs during the primary evaluation period. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better.
Measured: 12 months
Secondary outcomes (2)
Average Rhinitis Total Symptom Score (RTSS)
Average RTSS during the primary evaluation period. The daily Total Symptom Scores (RTSS) was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).
It ranges from 0 to 12. Lower is better.
Measured: 12 months
Average Rescue Medication Score (RMS)
Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start29 Sep 2015
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Demoly, MD, Principal investigator, CHU Arnaud de Villeneuve, Montpellier, FranceTom Casale, MD, Principal investigator, University of South of Florida, Tampa, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443805
- Sponsor's protocol ID
- SL75.14
- Status last verified
- Sep 2019
- First submitted
- 29 Apr 2015
- Last updated
- 14 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 39035788Pfaar 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.
PubMed 38225952