Efficacy and Safety Trial of ALK-depot SQ Mites in Subjec... | NCT00310492

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

NCT00310492

Sponsor

ALK-Abelló A/S

Status

Completed

Last Update Posted

Dec 29, 2015Estimated

Enrollment

154Actual

Phase

Phase 3

Conditions

Atopic Dermatitis

Interventions

subcutaneous immunotherapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

May 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Apr 2, 2006

First Submission Date that Met QC Criteria

Apr 2, 2006

First Posted Date

Apr 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2015

Last Update Posted Date

Dec 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subcutaneous immunotherapy	Active Comparator	Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U	Biological: subcutaneous immunotherapy
Subcutaneous injections	Placebo Comparator	placebo injections	Biological: subcutaneous immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
subcutaneous immunotherapy	Biological	Updosing by 16 injections to 100,000 SQ-U	Subcutaneous immunotherapy Subcutaneous injections

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
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)	1 year

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hendrik Wolf, PhD	ALK-SCHERAX Arzneimittel GmbH	Study Director
Alexander Kapp, MD, Prof.	Hannover Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie		Hanover		D-30449 Hannover	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided