A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma

A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis and/or Atopic Asthma Induced by House Dust Mites

To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.

Study Overview

• Status: Completed
• Conditions: Asthma; Allergy; Rhinitis
• Intervention / Treatment: Drug: Placebo; Drug: Mitizax

Detailed Description

To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days

To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days, compared to placebo

To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus, 220041
    • Minsk Regional Clinical Hospital
  • Minsk, Belarus, 220096
    • City Clinical Hopsital #10
• Russian Federation
  • Kazan, Russian Federation, 420103
    • Kazan state Medical Academy
  • Moscow, Russian Federation, 115478
    • National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
  • Moscow, Russian Federation, 123182
    • "Russian Medical Academy of Postgraduate Education Studies
  • Saint-Petersburg, Russian Federation, 193231
    • City out-patient's clinic # 94
  • Smolensk, Russian Federation
    • Smolensk State Medical Academy
  • Troitsk, Russian Federation, 142190
    • Hospital of Russian Academy of Science
  • Ufa, Russian Federation
    • Bashkirskiy State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent obtained before entering the study
• Patients 18-65 years of age, with a clinical history consistent with HDM-induced allergic rhinitis or allergic rhinoconjunctivitis with or without HDM-induced allergic atopic asthma for more than 1 year
• Use of symptomatic treatment of HDM-induced allergic rhinitis and/or HDM-induced atopic asthma, i.e. antihistamines, nasal decongestants, nasal and/or inhaled corticosteroid for more than 1 year
• if HDM-induced atopic asthma is present, it should be of mild to moderate severity, controlled on treatment corresponding to steps 1-3 of The Global initiative for asthma (GINA)
• Positive skin prick test response (wheal diameter ≥3 mm) to D pteronyssinus and/or D.farinae
• Moderate or higher level of D.pteronyssinus and/or D.farinae specific IgE (defined as ≥IgE Class 2; or ≥0.70 kilo unit (kU)/L)

• Patient one of the following:

  1. Male
  2. Female, infertile
  3. Female, with a negative pregnancy test and willingness to practice appropriate contraceptive methods until treatment with study drug has been discontinued.
• Patient willing and able to comply with study protocol

Exclusion Criteria:

• Previous treatment with HDM immunotherapy for more than 1 month within the last 5 years
• Ongoing treatment with any allergen-specific immunotherapy product
• Reduced lung function (defined as Forced expiratory volume in 1 second (FEV1) < 70% of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
• Clinical history of uncontrolled asthma within 3 months prior to the screening visit
• Having experienced a severe asthma exacerbation within 3 months prior to screening visit
• Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization
• Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomization
• History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction)
• History of recurrent generalized urticaria (defined as two or more episodes) during the last 2 years
• A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
• Any chronic disease (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality or any other diseases that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject)
• Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not)
• Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
• Currently treated with tricyclic antidepressants; catecholamine-O-methyltransferase (COMT) inhibitors and mono amine oxidase inhibitors (MAOIs) and beta-blockers including topical administration
• Use of medication at the screening visit which at the time of skin prick test (SPT) can interfere with the result (i.e. antihistamines)
• Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to the screening visit
• History of allergy, hypersensitivity or intolerance to a excipient in the investigational medicinal product (except D.Pteronyssinus and D.farinae)
• Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild
• Severe mental disorders that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject
• Cardiovascular conditions in which complications are possible when using adrenaline
• Women who are pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mitizax ALK HDM tablet; Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)	Drug: Mitizax; Allergen extract; Other Names: ALK HDM tablet; allergen extract
Placebo Comparator: Placebo tablet	Drug: Placebo; Placebo tablet; Other Names: Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
D. Farinae Specific IgG4 Change From Baseline to End of Treatment	primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment	60 days from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment	secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment	60 days from baseline
D. Farinae Specific IgE Change From Baseline to End of Treatment	the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo	60 days from baseline
D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment	the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo	60 days from baseline

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Datamap; Linical Co., Ltd.
• Investigators: Study Director: Dmitri Kazei, MD, Abbott

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: House Dust Mite
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Asthma; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: MITI3001