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

NCT02596321 | Completed Phase 3 Results

• 1 other identifier: MITI3001
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 9

Brief Summary

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.

Conditions

Allergy; Asthma; Rhinitis

Keywords

House Dust Mite

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  60 days from baseline

• D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment

  60 days from baseline

Study Arms (2)

Mitizax ALK HDM tablet

EXPERIMENTAL

Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)

Drug: Mitizax

Placebo tablet

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Interventions

Mitizax DRUG

Allergen extract

Also known as: ALK HDM tablet, allergen extract

Mitizax ALK HDM tablet

Placebo DRUG

Placebo tablet

Also known as: Placebo tablet

Placebo tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Male
• Female, infertile
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott: lead
• Linical Co., Ltd.: collaborator
• Datamap: collaborator

Study Sites (9)

Minsk Regional Clinical Hospital

Minsk, 220041, Belarus

Location

City Clinical Hopsital #10

Minsk, 220096, Belarus

Location

Kazan State Medical Academy

Kazan', 420103, Russia

Location

National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia

Moscow, 115478, Russia

Location

"Russian Medical Academy of Postgraduate Education Studies

Moscow, 123182, Russia

Location

City out-patient's clinic # 94

Saint Petersburg, 193231, Russia

Location

Smolensk State Medical Academy

Smolensk, Russia

Location

Hospital of Russian Academy of Science

Troitsk, 142190, Russia

Location

Bashkirskiy State Medical University

Ufa, Russia

Location

MeSH Terms

Conditions

Hypersensitivity; Asthma; Rhinitis

Interventions

Allergens

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Respiratory Tract Infections; Infections; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Clinical Director
• Organization: Abbott

dmitri.kazei@abbott.com

+31294477008

Study Officials

• Dmitri Kazei, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 4, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 1, 2018
• Results First Posted: December 18, 2017

Record last verified: 2018-02

Locations

BE (2); RU (7)