A randomized, double-blind, placebo-controlled, parallel group study evaluating efficacy and safety of QAW039 in the treatment of patients with moderate to severe atopic dermatitis (CQAW039X2201)
- Conditions
- atopic dermatitiseczema1000170810040790
- Registration Number
- NL-OMON40359
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
* Male or female adults aged 18-65 years.
* Atopic dermatitis (AD) (see protocol page 34 for details).
* Stable AD, EASI score *15 at screening.
* Has been treated with topical corticosteroids or topical calcineurin inhibitors on at least one occasion or could not use topical drugs (due to contraindications, side effects, etc.) and are candidates for or have previously received systemic treatment.
* History of serious allergic reactions to any allergen (see protocol page 35 for details).
* Clinically significant ECG abnormalities (see protocol page 35 for details).
* History of long QT syndrome or QTc measured at Visit 2 (Fridericia method) is prolonged (>450 ms for males and females).
* Use of topical prescription treatment within 2 weeks prior to initial dosing of study drug. Exception: see protocol page 35 for details.
* Recent previous systemic treatment. See protocol page 35 for types of treatment en wash-out.
* Patients on maintenance immunotherapy who either began their allergen specific immunotherapy regimen or had a clinically relevant change to their immunotherapy within 1 month prior to granting informed consent.
* High dose statin therapy (see protocol page 36 for details).
* Excessive exposure to UV light in the 3 weeks prior to screening (see protocol page 36 for details).
* BMI < 17 or > 40 kg/m2.
* Pregnancy and breast feeding. Inadequate contraception, if relevant.
* Serious co-morbidities (see protocol page 37 for details).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>EASI score week 12, adverse effects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>EASI score week 4 and 8.</p><br>