Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model

NCT01527188 | Completed Phase 2 Results

• 1 other identifier: VO67.10
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.

Conditions

Allergic Rhinitis Due to House Dust Mite

Keywords

HDM; allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge

  The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS\_0-4h. A decrease in the AUCRTSS\_0-4h value represents relief from the HDM allergic symptoms.

  6 months

Secondary Outcomes (1)

• Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge

  6 months

Study Arms (4)

100 IR

EXPERIMENTAL

100 IR house dust mites allergen extract tablet

Drug: 100 IR house dust mites allergen extract tablet

300 IR

EXPERIMENTAL

300 IR house dust mites allergen extract tablet

Drug: 300 IR house dust mites allergen extract tablet

500 IR

EXPERIMENTAL

500 IR house dust mites allergen extract tablet

Drug: 500 IR house dust mites allergen extract tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo tablet

Interventions

100 IR house dust mites allergen extract tablet DRUG

One sublingual tablet daily during 6 months

Also known as: Sublingual immunotherapy tablet

100 IR

300 IR house dust mites allergen extract tablet DRUG

One sublingual tablet daily during 6 months

Also known as: Sublingual immunotherapy tablet

300 IR

500 IR house dust mites allergen extract tablet DRUG

One sublingual tablet daily during 6 months

Also known as: Sublingual immunotherapy tablet

500 IR

Placebo tablet DRUG

One sublingual tablet daily during 6 months

Also known as: Sublingual placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• history of HDM rhinitis allergy for \> 1 year
• sensitized to D. pteronyssinus and/or D. farinae
• RTSS \>= 6 at least 2 time points during allergen challenge session

You may not qualify if:

• co sensitization to other allergen than HDM
• FEV1 \< 80%
• Asthma GINA \> 1

Sponsors & Collaborators

• Stallergenes Greer: lead

Study Sites (1)

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Location

Related Publications (1)

• 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: 39035788 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Michel Roux, Medical Director
• Organization: Stallergenes

mroux@stallergenes.com

+33 (0) 1 33 55 59 29 70

Study Officials

• Peter Couroux, MD, FRCPC

  Cetero Research / PRACS Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 1, 2012
• First Posted: February 6, 2012
• Study Start: December 8, 2010
• Primary Completion: March 1, 2012
• Study Completion: September 19, 2012
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Locations

CA (1)