NCT02443805

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,607

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2015

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

September 29, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 25, 2019

Completed
Last Updated

October 14, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

April 29, 2015

Results QC Date

August 29, 2019

Last Update Submit

September 26, 2019

Conditions

Rhinitis, Allergic, PerennialHouse Dust Mite Allergy

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • Average Rhinitis Total Symptom Score (RTSS)

    12 months

  • Average Rescue Medication Score (RMS)

    12 months

Study Arms (2)

300 IR

ACTIVE COMPARATOR

300 IR tablet of HDM Allergen Extracts

Biological: 300 IR

Placebo

PLACEBO COMPARATOR

Placebo tablet

Biological: Placebo

Interventions

300 IRBIOLOGICAL

300 IR tablet of HDM Allergen Extracts

300 IR
PlaceboBIOLOGICAL

Placebo tablet

Placebo

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South of Florida

Tampa, Florida, 33610, United States

Location

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

Related Publications (2)

  • 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.

    PMID: 39035788DERIVED

  • 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.

    PMID: 38225952DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialDust Mite Allergy

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Martine Le Gall, Director of Clinical Development
Organization
Stallergenes Greer
martine.legall@stallergenesgreer.com
+33 1 55 59 25 56

Study Officials

  • Pascal Demoly, MD

    CHU Arnaud de Villeneuve, Montpellier, France

    PRINCIPAL INVESTIGATOR

  • Tom Casale, MD

    University of South of Florida, Tampa, USA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
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

April 29, 2015

First Posted

May 14, 2015

Study Start

September 29, 2015

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

October 14, 2019

Results First Posted

September 25, 2019

Record last verified: 2019-09

Locations

FR(1)US(1)