Efficacy and safety study of QAW039 in the treatment of patients with moderate to severe atopic dermatitis
- Conditions
- Atopic dermatitisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-005321-78-NL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
- Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months plus three, or more, of the following:
• History of involvement of the skin creases (fronts of
elbows, behind knees, fronts of ankles, around neck or around eyes)
• Personal history of asthma or hay fever
• History of generally dry skin in the past year
• Onset before age of 2 years
• Visible flexural dermatitis
- Patients with an EASI score of =15 at screening and stable AD (not currently
experiencing an acute flare of their AD)
- Patients that have 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.
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 92
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they are using a effective method of birth control (as further defined in study protocol)
- Recent previous systemic treatment with phototherapy, systemic antihistamines, immunosuppressive agents such as cyclosporine, mycophenolate, or oral tacrolimus, or therapeutic proteins.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD)<br><br>- Eczema Area and Severity Index (EASI) score in comparison to placebo <br>- Number of Participants with Adverse Events to assess Safety and tolerability;Secondary Objective: To evaluate the efficacy of QAW039, as measured by EASI, after 4 and 8 weeks of<br>treatment in adult patients with moderate to severe AD.;Primary end point(s): - Change from baseline in Eczema Area and Severity Index (EASI) score to week 12 in comparison to placebo<br><br>- Number of Participants with Adverse Events used to assess Safety and tolerability after 12 weeks;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in Eczema Area and Severity Index score to 4 weeks and 8 weeks;Timepoint(s) of evaluation of this end point: week 4 and week 8