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CompletedNCT00310492Updated Dec 29, 2015

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

A Phase 3 interventional study of subcutaneous immunotherapy in Atopic Dermatitis, sponsored by ALK-Abelló A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-12-29.

Sponsored by ALK-Abelló A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 154 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

ALK-Abelló A/S is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
154 participants (actual)

Study arms

  • Active comparator
    Subcutaneous immunotherapy

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

    Biological: subcutaneous immunotherapy

  • Placebo comparator
    Subcutaneous injections

    placebo injections

    Biological: subcutaneous immunotherapy

Interventions

  • Biologicalsubcutaneous immunotherapy

    Updosing by 16 injections to 100,000 SQ-U

    Also known as: ALK-depot SQ mites

06

What researchers measure

Primary outcomes

  1. Changes from baseline in SCORAD and topical medication consumption

    Sccore of atopic dermatitis (SCORAD)

    Time frame: 1 year

Secondary outcomes

  1. Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption

    Eczema Area Severity Index (EASI)

    Time frame: 1 year

Other outcomes

  1. SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire

    Investigator´s Global Assessment (IGA), Dermatology Life Quality Index (DLQI)

    Time frame: 1 year

07

Study locations

1 site
  • Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie
    Hannover, D-30449 Hannover, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00310492
Lead sponsor
ALK-Abelló A/S
Responsible party
Sponsor
First posted
Apr 4, 2006
Start date
Apr 2006
Primary completion
May 2009
Completion
Nov 2009
Last update
Dec 29, 2015

Study contacts

Hendrik Wolf, PhD
study director · ALK-SCHERAX Arzneimittel GmbH
Alexander Kapp, MD, Prof.
principal investigator · Hannover Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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