Efficacy and safety study evaluating a new sublingual treatment in HDM allergic rhinitis

Phase 1

• Conditions: House dust mite allergic rhinitis; MedDRA version: 20.0Level: LLTClassification code 10001725Term: Allergic rhinitis due to other allergenSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004223-46-CZ
• Lead Sponsor: Stallergenes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-24
• Last Update Posted: 27 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1740

Inclusion Criteria

1. Have house dust mite (HDM)-associated allergic rhinitis (AR) (with or without asthma) for at least 1 year based on the presence of:
• Symptoms for 4 or more consecutive weeks in the previous year and for at least 4 days per week during those weeks.
• Symptoms requiring regular intake of symptomatic treatment(s).
• Symptoms evaluated as troublesome” by the patients or impairing their daily activities, leisure or sport, school or work or involving sleep disturbance.
2. Have given signed informed consent to participate, after having been informed of the nature and aims of the study, in accordance with local regulation and requirements.
3. Male or female outpatients 12 to 65 years of age.
4. Sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined as skin prick test wheal diameter at least 5 mm greater than the negative control and HDM-specific serum IgE =3.5 kU/L.
5. Willing to and capable of completing the e-diary, study questionnaires and scales.
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1540
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A history of rhinitis, rhino-conjunctivitis or asthma to allergens other
than HDM, likely to result in rhinitis symptoms during the baseline and
primary evaluation periods.
Specifically, when the following are present:
• documented sensitization (positive Skin Prick Test or allergen specific
serum IgE >3.5kU/L) and history of clinically relevant symptoms to
allergen(s) other than HDM,
• anticipated exposure to such allergen(s) during the baseline and
primary evaluation periods.
For example, the following patients are to be excluded:
- patients sensitized to cat or dog allergens and regularly exposed to these animals
- patients sensitized to perennial allergens, such as aspergillus, cladosporium, alternaria, cockroach
- patients sensitized to seasonal allergens such as parietaria, ragweed or mugwort, if these allergens are endemic in the region during the baseline and primary evaluation periods.
2. Any diagnosed nasal (other than HDM allergic rhinitis) or oral disease that could interfere with the efficacy or safety assessments, such as nasal polyposis, recurrent chronic rhino-sinusitis (at least 2 isolated episodes per year in the 2 previous years, each episode lasting more than 8 weeks) or a history of chronic oral inflammation or current active oral inflammation from any etiology (e.g., oral lichen planus, oral ulceration or oral mycosis) and/or oral wounds.
3. Recent nasal surgery (i.e., within the previous 6 months).
4. Partially controlled or uncontrolled asthma defined in the Global Initiative for Asthma 2014 guidelines (GINA 2014) as the presence of daytime asthma symptoms more than twice/week or nocturnal symptoms/awakening or need for reliever/rescue treatment more than twice/week or FEV1 <80% of predicted or personal best value.
5. Asthma therapies consistent with GINA treatment Step 3, Step 4 and Step 5 i.e., the preferred controller medication consists of inhaled corticosteroid (ICS) combined with long-acting beta (ß)-2 agonist (LABA) according to GINA classification 2014 (refer to Appendix II for the full details of other controller options).
6. Experienced a life-threatening asthma attack or an asthma exacerbation that resulted in Intensive Care Unit (ICU) hospitalization.
7. Requiring continuous treatment with systemic corticosteroids for any indication.
8. Requiring continuous treatment with ß-blockers or with Monoamine Oxidase Inhibitors (MAOIs).
9. Received an immunosuppressive treatment within 3 months prior to screening.
10. Received allergen specific immunotherapy (AIT) by any route:
- for house dust mites: AIT for more than 1 month within the 5 years before screening
- for other allergen(s): ongoing or recently stopped (within 6 months) AIT.
11. Any history of anaphylaxis after previous allergen immunotherapy, exposure to allergen(s) or of unknown cause.
12. Any history of hypersensitivity to STG320 or its excipients or contraindication to the use of rescue medications
13. Female with positive urine pregnancy test or lactating or expecting to conceive within the duration of the study.
14. Sexually active female of child-bearing potential without medically accepted contraceptive method
15. Unable or unwilling to comply with the study protocol requirements, including those who anticipate significant changes in their daily environment in relation to HDM exposure or who are likely to travel for extended periods of time during the main efficacy assessment period.
16. Patients with p

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate 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 allergic rhinitis.;Secondary Objective: - To assess the efficacy of STG320 sublingual tablets at dosage of 300 IR <br>- Rhinoconjunctivitis symptom evaluation and rescue medication use will also be evaluated during the 2-week secondary evalutation period<br>- To assess the effect of STG320 on other variables at the end of treatment (work productivity and activity impairment, immunological markers);Primary end point(s): Total Combined Score (TCS). The average TCS is calculated for each patient as the average of the non-missing daily TCSs.<br>The daily TCS (scale 0-15) is the sum of the patient’s daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). ;Timepoint(s) of evaluation of this end point: All along the study

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: All along the study;Secondary end point(s): Rhinitis Total Symptom Score (RTSS) <br>Rescue Medication Score (RMS)<br>Adjusted Symptom Score (ASS, scale 0-12) <br>Combined Symptom and Medication Score (CSMS, scale 0-6)<br>Total Ocular Symptom Score (TOSS, scale 0-6)<br>Six Individual Rhinoconjunctivitis Symptom Scores (RSSs)<br>Rhinoconjunctivitis rescue medication usage<br>Visual Analogue Scale (VAS)<br>Proportion of Symptom-Controlled Days (PSCD) <br>Controlled patients (CP) <br>Overall Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)=12) scores<br>EQ-5D-5L Generic health-related quality of life questionnaire<br>Global Rating of Change Score (GRCS)