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Trial record 3 of 32 for:    Dermatophagoides pteronyssinus AND Dermatophagoides farinae

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596321
Recruitment Status : Completed
First Posted : November 4, 2015
Results First Posted : December 18, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborators:
Linical Co., Ltd.
Datamap
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Allergy
Asthma
Rhinitis
Interventions Drug: Mitizax
Drug: Placebo
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mitizax ALK HDM Tablet Placebo Tablet
Hide Arm/Group Description

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

Mitizax: Allergen extract

Placebo tablet

Placebo: Placebo tablet

Period Title: Overall Study
Started 56 56
Completed 53 56
Not Completed 3 0
Arm/Group Title Mitizax ALK HDM Tablet Placebo Tablet Total
Hide Arm/Group Description

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

Mitizax: Allergen extract

Placebo tablet

Placebo: Placebo tablet

Total of all reporting groups
Overall Number of Baseline Participants 56 56 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
<=18 years
3
   5.4%
1
   1.8%
4
   3.6%
Between 18 and 65 years
53
  94.6%
55
  98.2%
108
  96.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 56 participants 112 participants
31.7  (9.1) 31.4  (9.8) 31.6  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
Female
27
  48.2%
32
  57.1%
59
  52.7%
Male
29
  51.8%
24
  42.9%
53
  47.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
Belarus
12
  21.4%
12
  21.4%
24
  21.4%
Russia
44
  78.6%
44
  78.6%
88
  78.6%
1.Primary Outcome
Title D. Farinae Specific IgG4 Change From Baseline to End of Treatment
Hide Description primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment
Time Frame 60 days from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitizax ALK HDM Tablet Placebo Tablet
Hide Arm/Group Description:

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

Mitizax: Allergen extract

Placebo tablet

Placebo: Placebo tablet

Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: mg antibody/ml
0.473  (1.183) -0.01  (0.067)
2.Secondary Outcome
Title D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment
Hide Description secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment
Time Frame 60 days from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitizax ALK HDM Tablet Placebo Tablet
Hide Arm/Group Description:

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

Mitizax: Allergen extract

Placebo tablet

Placebo: Placebo tablet

Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: mg antibody/ml
0.455  (1.210) 0.001  (0.076)
3.Secondary Outcome
Title D. Farinae Specific IgE Change From Baseline to End of Treatment
Hide Description the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo
Time Frame 60 days from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitizax ALK HDM Tablet Placebo Tablet
Hide Arm/Group Description:

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

Mitizax: Allergen extract

Placebo tablet

Placebo: Placebo tablet

Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: kUA/L
140.37  (288.15) -5.56  (16.30)
4.Secondary Outcome
Title D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment
Hide Description the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo
Time Frame 60 days from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitizax ALK HDM Tablet Placebo Tablet
Hide Arm/Group Description:

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

Mitizax: Allergen extract

Placebo tablet

Placebo: Placebo tablet

Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: kUA/L
124.85  (286.90) -5.16  (27.27)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mitizax ALK HDM Tablet Placebo Tablet
Hide Arm/Group Description

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

Mitizax: Allergen extract

Placebo tablet

Placebo: Placebo tablet

All-Cause Mortality
Mitizax ALK HDM Tablet Placebo Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mitizax ALK HDM Tablet Placebo Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/56 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mitizax ALK HDM Tablet Placebo Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/56 (25.00%)      4/56 (7.14%)    
Gastrointestinal disorders     
Oral soft tissue signs and symptoms   9/56 (16.07%)  9 1/56 (1.79%)  1
Tongue signs and symptoms   3/56 (5.36%)  3 0/56 (0.00%)  0
Infections and infestations     
Upper respiratory tract infections   0/56 (0.00%)  0 3/56 (5.36%)  3
Nervous system disorders     
Headaches NEC   3/56 (5.36%)  3 1/56 (1.79%)  1
Respiratory, thoracic and mediastinal disorders     
Upper raspiratory tract signs and symptoms   5/56 (8.93%)  6 0/56 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Clinical Director
Organization: Abbott
Phone: +31294477008
EMail: dmitri.kazei@abbott.com
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02596321     History of Changes
Other Study ID Numbers: MITI3001
First Submitted: November 2, 2015
First Posted: November 4, 2015
Results First Submitted: July 21, 2017
Results First Posted: December 18, 2017
Last Update Posted: March 1, 2018