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

December 28, 2015 updated by: ALK-Abelló A/S

Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study to Demonstrate the Efficacy of a 12-month Subcutaneous Specific Immunotherapy With ALK-depot SQ Milbenmischung in Patients With Atopic Dermatitis and Proven IgE-mediated Sensitization to House Dust Mites

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subcutaneous immunotherapy
Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U
Biological: subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Other Names:
  • ALK-depot SQ mites
Placebo Comparator: Subcutaneous injections
placebo injections
Biological: subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Other Names:
  • ALK-depot SQ mites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in SCORAD and topical medication consumption
Time Frame: 1 year
Sccore of atopic dermatitis (SCORAD)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption
Time Frame: 1 year
Eczema Area Severity Index (EASI)
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire
Time Frame: 1 year
Investigator´s Global Assessment (IGA), Dermatology Life Quality Index (DLQI)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Alexander Kapp, MD, Prof., Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 2, 2006

First Submitted That Met QC Criteria

April 2, 2006

First Posted (Estimate)

April 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHX0556

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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