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

House Dust Mite Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094845
• Other study ID #: ABT-hdmASIT001
• Secondary ID: 2016-000557-13
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2017
• Last updated: March 23, 2017
• Start date: September 28, 2016
• Est. completion date: January 23, 2017

Study information

• Verified date: March 2017
• Source: ASIT Biotech S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 23, 2017
• Est. primary completion date: January 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• House Dust Mite Allergy

Intervention

Biological:
• Placebo solution
15 injections over 7 weeks
• hdmASIT+TM
15 injections over 7 weeks

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl Gustav Carus	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
ASIT Biotech S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited adverse events	Local reactions at the injection site; Allergic systemic reactions	up to 7 weeks
Secondary	Unsolicited adverse events and serious adverse events (SAEs)		up to 12 weeks
Secondary	Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure)		up to 12 weeks
Secondary	Laboratory investigations (haematology, clinical biochemistry, immunological parameters)		up to 12 weeks
Secondary	Pulmonary functions (FEV1) for asthmatic patients		up to 7 weeks