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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
subcutaneous immunotherapy
Sponsored by
ALK-Abelló A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Subcutaneous immunotherapy

Subcutaneous injections

Arm Description

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

placebo injections

Outcomes

Primary Outcome Measures

Changes from baseline in SCORAD and topical medication consumption
Sccore of atopic dermatitis (SCORAD)

Secondary Outcome Measures

Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption
Eczema Area Severity Index (EASI)

Full Information

First Posted
April 2, 2006
Last Updated
December 28, 2015
Sponsor
ALK-Abelló A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00310492
Brief Title
Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous immunotherapy
Arm Type
Active Comparator
Arm Description
Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U
Arm Title
Subcutaneous injections
Arm Type
Placebo Comparator
Arm Description
placebo injections
Intervention Type
Biological
Intervention Name(s)
subcutaneous immunotherapy
Other Intervention Name(s)
ALK-depot SQ mites
Intervention Description
Updosing by 16 injections to 100,000 SQ-U
Primary Outcome Measure Information:
Title
Changes from baseline in SCORAD and topical medication consumption
Description
Sccore of atopic dermatitis (SCORAD)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption
Description
Eczema Area Severity Index (EASI)
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire
Description
Investigator´s Global Assessment (IGA), Dermatology Life Quality Index (DLQI)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Wolf, PhD
Organizational Affiliation
ALK-SCHERAX Arzneimittel GmbH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexander Kapp, MD, Prof.
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie
City
Hannover
ZIP/Postal Code
D-30449 Hannover
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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