A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet (MT-06)

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: House Dust Mite Allergy

Treatments: Biological: AIT Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01454544

2011-002277-38 (EudraCT Number)

MT-06

Details and patient eligibility

About

The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.

Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.

Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.

Enrollment: 992 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A history of house dust mite allergy
• Use of symptomatice medication for treatment of house dust mite allergy
• Positive skin prick test to mites
• Positive specific IgE

Exclusion criteria

• History of uncontrolled asthma
• Overlapping symptomatice allergies
• Previous treatment with immunotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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992 participants in 3 patient groups, including a placebo group

ALK house dust mite tablet 6 DU

Experimental group

Treatment:

Biological: AIT Tablet

ALK house dust mite tablet 12 DU

Experimental group

Treatment:

Biological: AIT Tablet

Placebo

Placebo Comparator group

Treatment:

Biological: AIT Tablet