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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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