Trial Outcomes & Findings for 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 (NCT NCT02596321)

NCT ID: NCT02596321

Last Updated: 2018-03-01

Results Overview

primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 112 participants
• Primary outcome timeframe: 60 days from baseline
• Results posted on: 2018-03-01

Participant Flow

Participant milestones

Measure	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) Mitizax: Allergen extract	Placebo Tablet Placebo tablet Placebo: Placebo tablet
Overall Study STARTED	56	56
Overall Study COMPLETED	53	56
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mitizax ALK HDM Tablet n=56 Participants 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 n=56 Participants Placebo tablet Placebo: Placebo tablet	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	55 Participants n=7 Participants	108 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.7 years STANDARD_DEVIATION 9.1 • n=5 Participants	31.4 years STANDARD_DEVIATION 9.8 • n=7 Participants	31.6 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment Belarus	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Russia	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days from baseline

primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment

Outcome measures

Measure	Mitizax ALK HDM Tablet n=53 Participants 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 n=56 Participants Placebo tablet Placebo: Placebo tablet
D. Farinae Specific IgG4 Change From Baseline to End of Treatment	0.473 mg antibody/ml Standard Deviation 1.183	-0.01 mg antibody/ml Standard Deviation 0.067

SECONDARY outcome

Timeframe: 60 days from baseline

secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment

Outcome measures

Measure	Mitizax ALK HDM Tablet n=53 Participants 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 n=56 Participants Placebo tablet Placebo: Placebo tablet
D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment	0.455 mg antibody/ml Standard Deviation 1.210	0.001 mg antibody/ml Standard Deviation 0.076

SECONDARY outcome

Timeframe: 60 days from baseline

the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo

Outcome measures

Measure	Mitizax ALK HDM Tablet n=53 Participants 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 n=56 Participants Placebo tablet Placebo: Placebo tablet
D. Farinae Specific IgE Change From Baseline to End of Treatment	140.37 kUA/L Standard Deviation 288.15	-5.56 kUA/L Standard Deviation 16.30

SECONDARY outcome

Timeframe: 60 days from baseline

the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo

Outcome measures

Measure	Mitizax ALK HDM Tablet n=53 Participants 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 n=56 Participants Placebo tablet Placebo: Placebo tablet
D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment	124.85 kUA/L Standard Deviation 286.90	-5.16 kUA/L Standard Deviation 27.27

Adverse Events

Mitizax ALK HDM Tablet

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Tablet

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mitizax ALK HDM Tablet n=56 participants at risk 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 n=56 participants at risk Placebo tablet Placebo: Placebo tablet
Gastrointestinal disorders Oral soft tissue signs and symptoms	16.1% 9/56 • Number of events 9	1.8% 1/56 • Number of events 1
Gastrointestinal disorders Tongue signs and symptoms	5.4% 3/56 • Number of events 3	0.00% 0/56
Infections and infestations Upper respiratory tract infections	0.00% 0/56	5.4% 3/56 • Number of events 3
Respiratory, thoracic and mediastinal disorders Upper raspiratory tract signs and symptoms	8.9% 5/56 • Number of events 6	0.00% 0/56
Nervous system disorders Headaches NEC	5.4% 3/56 • Number of events 3	1.8% 1/56 • Number of events 1

Additional Information

Therapeutic Area Clinical Director

Abbott

Phone: +31294477008

Email: dmitri.kazei@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place