A randomized, double-blind, placebo-controlled (DBPC) parallel-group multi-centre study to assess the efficacy and safety of PURETHAL Mites subcutaneous immunotherapy (SCIT) in patients with allergic rhinitis/rhinoconjunctivitis (ARC) caused by house dust mite (HDM) allergy

Phase 1

• Conditions: Allergic rhinitis/rhinoconjunctivitis (ARC) caused by house dust mite (HDM) allergy.; MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000014962; MedDRA version: 20.0Level: LLTClassification code 10001724Term: Allergic rhinitis (excl hay fever)System Organ Class: 100000016169; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-000051-27-HU
• Lead Sponsor: HAL Allergy B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-14
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

1. Patients who signed their informed consent form.
2. Patients aged =18 and =65 years at signing of informed consent form.
3. Patients with moderate to severe HDM-induced allergic rhinitis or rhinoconjunctivitis (based on ARIA classification) for at least one year prior to screening; with or without concomitant asthma (asthma must be controlled (GINA 2010)).
4. Patients with a history of concomitant asthma must have an FEV1 >70% of predicted value, at screening. Patients without a history of asthma must have an FEV1 >70% or a PEF >80% of predicted value at screening.
5. Patient that reported a mean CSMS(n) =1.5 during the baseline period .
6. Patients that are willing and capable to complete an e-diary daily during 12 weeks of the study (=60% compliance in e-diary completion during the 14 days baseline period).
7. Patients with a positive SPT for HDM D. pter or D. far (mean wheal diameter =3 mm compared to negative control; for negative control a reaction up to 2 mm is allowed; histamine control should be positive (mean wheal diameter =3 mm) assessed during screening or a documented positive response obtained within one year before screening.
8. Patients with an allergen specific serum IgE (ssIgE) level for HDM D. pter or D. far of =0.7 U/mL assessed during screening.
9. Patients with a positive NPT for HDM D. pter extract during screening (Lebel score =6 at 10,000 AU/mL), test should be postponed if baseline score is =3 or if negative control is >3.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 730
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter =3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter =3 mm)) to other allergens than HDM, if they have expected clinically relevant symptoms related to the other allergen, overlapping with either the 8-week efficacy assessment period and/or the screening/baseline period, based on the judgement of the investigator.
2. Patients sensitized and symptomatic to pets, that will be regularly exposed to pets during the study period.
3. Patients with a history of anaphylaxis with cardio-respiratory symptoms (food allergy, drugs or an idiopathic reaction).
4. Patients who received immunotherapy (SCIT or SLIT) with HDM allergens within the past 5 years.
5. Patients with unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the past 5 years (e.g., but not limited to, prematurely stopped immunotherapy due to non-compliance, AEs, or lack of therapeutic effect).
6. Patients who undergo allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period (screening up to EoS).
7. Patients who participated in a clinical interventional study within the last 3 months (e.g. new investigational drug or biological) or in an observational study within the last 30 days (e.g. post marketing study), or plans on participating in another clinical trial during the duration of
this study, at the discretion of the investigator.
8. Patients that (will) receive any vaccination (including influenza vaccine) one week before start of treatment and/or during the up-dosing phase.
9. Patients undergoing any immunosuppressive treatment (e.g. anti-IgE therapy) within the last 6 months prior to inclusion and up to EoS.
10. Patients suffering from severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
11. Patients suffering from active malignancies or any malignant disease during 5 years prior to screening.
12. Patients suffering from any chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: clinically significant abnormal ECG at screening or cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, haematological disorders, severe atopic dermatitis.
13. Patients suffering from any disease with a contra-indication for the use of epinephrine/adrenaline (e.g. hyperthyroidism, glaucoma).
14. Patients receiving treatment with systemic corticosteroids 4 weeks before screening, nasal corticosteroids 2 weeks before the screening,
antihistamines 3 days before screening during the indicated timeframe as listed in Table 4.
15. Patients receiving treatment with systemic or local beta-blockers (including beta-blocker containing eye drops) any time during the study.
16. Patients suffering from moderate to severe nasal obstructive disease such as polyps, septum deviations, etc.
17. Patients suffering from clinically significant chronic sinusitis or ocular infection.
18. Female patients of child-bearing potential who are pregnant, lactating or using inadequate contraceptive measures.
Contraceptive measures considered adequate are:
1) hormonal contraceptives such as contraceptive pills, transdermal patches, intrauterine dev

Study & Design

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