Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma

NCT01930461 | Completed Phase 2 DMC

• 1 other identifier: VO72.12
• Study Type: interventional
• Target: 386
• Locations: 3 countries
• Sites: 5

Brief Summary

The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.

Conditions

Asthma; House Dust Mite Allergy

Outcome Measures

Primary Outcomes (1)

• Effect on the Asthma control test (ACT) score

  Assessment of the effect of one year of treatment of 3 different doses of sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma

  13 months

Secondary Outcomes (1)

• Number and percentage of subjects with treatment-emergent AEs

  Measured during 13 months

Other Outcomes (1)

• Changes of Immunological parameters (HDM-specific IgE and IgG4 values)

  13 months

Study Arms (4)

SLIT (A)

EXPERIMENTAL

SLIT tablets of HDM allergen extracts, 3 different doses (A)

Biological: SLIT tablets of HDM allergen extracts, 3 different doses (A)

SLIT (B)

EXPERIMENTAL

SLIT tablets of HDM allergen extracts, 3 different doses (B)

Biological: SLIT tablets of HDM allergen extracts, 3 different doses (B)

SLIT (C)

EXPERIMENTAL

SLIT tablets of HDM allergen extracts, 3 different doses (C)

Biological: SLIT tablets of HDM allergen extracts, 3 different doses (C)

Placebo

PLACEBO COMPARATOR

Placebo matching the SLIT tablets of HDM allergen extracts

Biological: Placebo matching the SLIT tablets of HDM allergen extracts

Interventions

SLIT tablets of HDM allergen extracts, 3 different doses (A) BIOLOGICAL

Two sublingual tablets daily for 13 months

Also known as: Sublingual immunotherapy tablet

SLIT (A)

SLIT tablets of HDM allergen extracts, 3 different doses (B) BIOLOGICAL

Two sublingual tablets daily for 13 months

Also known as: Sublingual immunotherapy tablet

SLIT (B)

SLIT tablets of HDM allergen extracts, 3 different doses (C) BIOLOGICAL

Two sublingual tablets daily for 13 months

Also known as: Sublingual immunotherapy tablet

SLIT (C)

Placebo matching the SLIT tablets of HDM allergen extracts BIOLOGICAL

Two sublingual tablets daily for 13 months

Also known as: Sublingual placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent.
• Male or female from 18 to 50 years of age.
• Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.
• Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L.
• Stable asthma therapies.
• Spirometry (pre-bronchodilator) with best FEV1 ≥ 70% of the predicted value.
• Spirometry with reversibility in FEV1 of ≥ 12% and ≥ 200 mL.
• Asthma Control Test™ (ACT) score ≤ 19.

You may not qualify if:

• Former smoker with \> 10 pack year history or current smoker.
• Patient with a urine level of cotinine ≥ 500 ng/mL.
• Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
• Patient who received allergen immunotherapy for HDM within the past 10 years.
• Ongoing immunotherapy for an aeroallergen other than house dust mite.
• Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
• Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
• Pregnant women or breast-feeding/lactating.
• Women with childbearing potential who are not using a medically accepted birth control method.
• 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.

Sponsors & Collaborators

• Stallergenes Greer: lead

Study Sites (5)

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

NHC, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Universitätsmedizin Berlin - Allergie-Centrum-Charité

Berlin, 10117, Germany

Location

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi

Lodz, 90-153, Poland

Location

Majorek-Olechowska Bernadetta

Tarnów, 33-100, Poland

Location

MeSH Terms

Conditions

Asthma; Dust Mite Allergy

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pascal Demoly, MD

  Montpellier, France

  PRINCIPAL INVESTIGATOR

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: August 16, 2013
• First Posted: August 29, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

FR (2); DE (1); PL (2)