AMBITIOUSAtopic Dermatitis Biomarker Identification Trial in Omalizumab UsageSingle- arm trial to identify potential markers underlying variability in response to Omalizumab (Xolair®) treatment in atopic dermatitis - AMBITIOUS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

•Age 18 years or above
•Dermatological diagnosis of AD, SCORAD >=20
•Eligible to receive systemic therapy for AD in accordance to local guidelines
•Signed informed consent from patient

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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
•Previous treatment with Omalizumab
•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)
•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) or with known hypersensitivity to the trial’s rescue- or escalation-medication or related drugs (e.g.: loratadine, clemastine)
•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objectives<br>To identify clinical, metabolomic and transcriptomic markers that underlie variability in response to Omalizumab treatment in a sample of adult patients with moderate to severe atopic dermatitis<br>;Secondary Objective: Secondary objectives<br>To identify metabolomic and transcriptomic signatures associated with atopic dermatitis<br>To search for genetic variants correlated to atopic-atopic dermatitis-associated metabotypes<br>To identify Omalizumab-specific metabolomic signatures<br>;Primary end point(s): Primary objectives<br>1.To identify clinical and metabolomic markers that underlie variability in response to Omalizumab treatment in a sample of adult patients with moderate to severe AD<br>Secondary objectives<br>1.To identify metabolomic signatures associated with AD<br>2.To search for genetic variants correlated to AD-associated metabotypes<br>3.To identify Omalizumab-specific metabolomic <br>

Secondary Outcome Measures