Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Biological: subcutaneous immunotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310492

SHX0556

Details and patient eligibility

About

This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis

Enrollment: 154 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive specific IgE to house dust mites
• Atopic dermatitis according to Hanifin/Rajka
• Chronic course of Atopic dermatitis
• SCORAD larger than 25 points

Exclusion criteria

• Erythrodermia
• Syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks
• History of specific immunotherapy with mites
• UV radiation
• Group 4 topical corticosteroids (European classification)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups, including a placebo group

Subcutaneous immunotherapy

Active Comparator group

Description:

Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U

Treatment:

Biological: subcutaneous immunotherapy

Subcutaneous injections

Placebo Comparator group

Description:

placebo injections

Treatment:

Biological: subcutaneous immunotherapy