Atopic DermatitisPhase 3NCT00310492
Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis
A Phase 3 study testing subcutaneous immunotherapy in people with Atopic Dermatitis, run by ALK-Abelló A/S at 1 site in Germany.
Trial summary
This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- subcutaneous immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2006to Nov 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive specific IgE to house dust mites
- Atopic dermatitis according to Hanifin/Rajka
- Chronic course of Atopic dermatitis
- SCORAD larger than 25 points
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie
Hanover, D-30449 Hannover
About this study
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
This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- subcutaneous immunotherapy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous immunotherapyBiological
Also called ALK-depot SQ mites
Updosing by 16 injections to 100,000 SQ-U
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous immunotherapy | Active comparator | Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U Receives: Biological: subcutaneous immunotherapy |
| Subcutaneous injections | Placebo comparator | placebo injections Receives: Biological: subcutaneous immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in SCORAD and topical medication consumption
Sccore of atopic dermatitis (SCORAD)
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hendrik Wolf, PhD, Study director, ALK-SCHERAX Arzneimittel GmbHAlexander Kapp, MD, Prof., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310492
- Sponsor's protocol ID
- SHX0556
- Status last verified
- Dec 2015
- First submitted
- 2 Apr 2006
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00310492
- Acronym / sponsor ID
- SHX0556
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous immunotherapy | Active comparator | Biological: subcutaneous immunotherapySubcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U |
| Subcutaneous injections | Placebo comparator | Biological: subcutaneous immunotherapyplacebo injections |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Positive specific IgE to house dust mites
- Atopic dermatitis according to Hanifin/Rajka
- Chronic course of Atopic dermatitis
- SCORAD larger than 25 points
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous immunotherapyAlso: ALK-depot SQ mitesUpdosing by 16 injections to 100,000 SQ-U | Biological | Subcutaneous immunotherapy, Subcutaneous injections |
Primary outcome
Changes from baseline in SCORAD and topical medication consumption
Time frame: 1 year
Sccore of atopic dermatitis (SCORAD)
1 secondary outcome
Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Wolf, PhD study director
ALK-SCHERAX Arzneimittel GmbH
Alexander Kapp, MD, Prof. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing subcutaneous immunotherapy in people with Atopic Dermatitis, run by ALK-Abelló A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in SCORAD and topical medication consumption (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.