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

Assessment of Safety and Clinical Tolerability of hdmASIT+TM Administered Subcutaneously in House Dust Mite-induced Allergic Rhinoconjunctivitis Patients

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.

Study Overview

• Status: Completed
• Conditions: House Dust Mite Allergy
• Intervention / Treatment: Biological: Placebo solution; Biological: hdmASIT+TM

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo solution; 15 injections over 7 weeks
Experimental: hdmASIT+TM	Biological: hdmASIT+TM; 15 injections over 7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited adverse events	Local reactions at the injection site; Allergic systemic reactions	up to 7 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Unsolicited adverse events and serious adverse events (SAEs)	up to 12 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
Pulmonary functions (FEV1) for asthmatic patients	up to 7 weeks

Collaborators and Investigators

• Sponsor: ASIT Biotech S.A.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2016
• Primary Completion (Actual): January 12, 2017
• Study Completion (Actual): January 23, 2017

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ABT-hdmASIT001; 2016-000557-13 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No