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

NCT03094845 | Completed Phase 2

• 2 other identifiers: ABT-hdmASIT0012016-000557-13
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

House Dust Mite Allergy

Outcome Measures

Primary Outcomes (1)

• Solicited adverse events

  * Local reactions at the injection site * Allergic systemic reactions

  up to 7 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Biological: Placebo solution

hdmASIT+TM

EXPERIMENTAL

Biological: hdmASIT+TM

Interventions

Placebo solution BIOLOGICAL

15 injections over 7 weeks

Placebo

hdmASIT+TM BIOLOGICAL

15 injections over 7 weeks

hdmASIT+TM

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASIT Biotech S.A.: lead

Study Sites (1)

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Dust Mite Allergy

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 29, 2017
• Study Start: September 28, 2016
• Primary Completion: January 12, 2017
• Study Completion: January 23, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

DE (1)