Atopic DermatitisPhase 2AMB-WEI-1052-INCT01179529
Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage
A Phase 2 study testing Omalizumab (Xolair®) in people with Atopic Dermatitis and Atopic Eczema, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis, and to work out biomarkers predictive of treatment response. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis, Atopic Eczema
- What is being tested?
- Omalizumab (Xolair®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18-70 years of age, body weight ≥ 20 kg and ≤ 150 kg
- Dermatological diagnosis of AD, SCORAD >=20
- A positive RAST (≥CAP1) result for at least one aeroallergen specific IgE and total IgE >=100kU/l at screening (or within the previous 12 months)
- Eligible to receive systemic therapy for AD in accordance to local guidelines
- Signed informed consent from patient
Who cannot join
- Evidence of skin disease other than AD (e.g. psoriasis) at the inclusion time
- Treatment with systemic AD medications or any investigational drug within a 30-day washout period
- Concomitant treatment with substances interfering with the immune system
- Permanent severe diseases, especially those affecting the immune system, except asthma
- Pregnancy or breast feeding
- History of food or drug related severe anaphylactoid or anaphylactic reaction(s)
Show all 19Show fewer
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
- Elevated serum IgE levels for reasons other than allergy and/or urticaria (e.g.: parasite infections, hyperimmunoglobulin E syndrome, Wiskott - Aldrich syndrome or clinical allergic bronchopulmonary aspergillosis)
- Evidence of severe renal dysfunction or significant hepatic disease
- Evidence for active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- Clinically significant laboratory abnormalities (not associated with AD) at Visit 1
- Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to Omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin)
- Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
- Patients with serious psychiatric and/or psychological disturbances
- Patients with a history of drug or alcohol abuse
- Patients who are unable to complete a patient diary or complete questionnaires on paper
- Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar Dermatologie/Biederstein
Munich, Bavaria, 80802
About this study
Official title: Single- Arm Trial to Identify Potential Markers Underlying Variability in Response to Omalizumab (Xolair®) Treatment in Atopic Dermatitis
This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis, and to work out biomarkers predictive of treatment response.
- Conditions
- Atopic Dermatitis, Atopic Eczema
- Being tested
- Omalizumab (Xolair®)
- Keywords
- Atopic dermatitis (atopic eczema)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab (Xolair®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Not described Receives: Drug: Omalizumab (Xolair®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate efficacy of Omalizumab treatment in a sample of adult patients with moderate to severe AD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Stephan Weidinger, Prof.Dr.med., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179529
- Sponsor's protocol ID
- AMBITIOUS
- Acronym
- AMB-WEI-1052-I
- Status last verified
- Jan 2012
- First submitted
- 2 Aug 2010
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single- Arm Trial to Identify Potential Markers Underlying Variability in Response to Omalizumab (Xolair®) Treatment in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01179529
- Acronym / sponsor ID
- AMB-WEI-1052-I / AMBITIOUS
- Conditions
- Atopic Dermatitis, Atopic Eczema
- Keywords
- Atopic dermatitis (atopic eczema)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- First posted
- 11 Aug 2010 (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 study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis, and to work out biomarkers predictive of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: Omalizumab (Xolair®) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18-70 years of age, body weight ≥ 20 kg and ≤ 150 kg
- Dermatological diagnosis of AD, SCORAD >=20
- A positive RAST (≥CAP1) result for at least one aeroallergen specific IgE and total IgE >=100kU/l at screening (or within the previous 12 months)
- Eligible to receive systemic therapy for AD in accordance to local guidelines
- Signed informed consent from patient
Key exclusion criteria (19 listed)
- Evidence of skin disease other than AD (e.g. psoriasis) at the inclusion time
- Treatment with systemic AD medications or any investigational drug within a 30-day washout period
- Concomitant treatment with substances interfering with the immune system
- Permanent severe diseases, especially those affecting the immune system, except asthma
- Pregnancy or breast feeding
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 |
|---|---|---|
| Omalizumab (Xolair®) | Drug | Omalizumab |
Primary outcome
To evaluate efficacy of Omalizumab treatment in a sample of adult patients with moderate to severe AD
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 10 Jan 2012.
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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.
Stephan Weidinger, Prof.Dr.med. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab (Xolair®) in people with Atopic Dermatitis and Atopic Eczema, run by Technical University of Munich 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 5 inclusion and 19 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 10 Jan 2012. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate efficacy of Omalizumab treatment in a sample of adult patients with moderate to severe AD. 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 10 Jan 2012.