Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients

Phase 2

Completed

• Conditions: House Dust Mite Allergy
• Interventions: Biological: hdmASIT+TM; Biological: Placebo solution

• Registration Number: NCT03094845
• Lead Sponsor: ASIT Biotech S.A.

Brief Summary

hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-28
• Primary Completion: 2017-01-12
• Study Completion: 2017-01-23
• Status Verified: 2017-03
• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-23
• Last Update Submitted: 2017-03-23
• Study First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al., 2001))
• A positive skin prick test to house dust mite Dermatophagoides pteronyssinus
• Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L
• Positive response to Conjunctival Provocation Test (CPT)
• Being treated with anti-allergic medication for at least 12 months prior to enrollment
• For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value

Exclusion Criteria

• Previous immunotherapy with house dust mite allergens within the last 5 years
• Ongoing immunotherapy with house dust mite allergens or any other allergens
• History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
• Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
• Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient's reference value (ECSC)
• History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hdmASIT+TM	hdmASIT+TM	-
Placebo	Placebo solution	-

Primary Outcome Measures

Name	Time	Method
Solicited adverse events	up to 7 weeks	* Local reactions at the injection site; * Allergic systemic reactions

Secondary Outcome Measures

Name	Time	Method
Unsolicited adverse events and serious adverse events (SAEs)	up to 12 weeks
Pulmonary functions (FEV1) for asthmatic patients	up to 7 weeks
Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure)	up to 12 weeks
Laboratory investigations (haematology, clinical biochemistry, immunological parameters)	up to 12 weeks

Trial Locations

Locations (1)

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany