Efficacy and safety study of QAW039 in the treatment of patients with moderate to severe atopic dermatitis

• Register: EUCTR
• Last refreshed on: 1 December 2014
• Main ID: EUCTR2012-005321-78-AT
• Date of registration: 25/03/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Efficacy and safety study of QAW039 in the treatment of patients with moderate to severe atopic dermatitis
• Scientific title: 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
• Date of first enrolment: 24/04/2013
• Target sample size: 92
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005321-78
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Germany, Netherlands, Romania, South Africa

Key inclusion & exclusion criteria

Inclusion criteria:
- 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

Exclusion criteria:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Atopic dermatitis

Intervention(s)

Product Code: QAW039
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

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)

- Eczema Area and Severity Index (EASI) score in comparison to placebo
- Number of Participants with Adverse Events to assess Safety and tolerability

Primary end point(s): - Change from baseline in Eczema Area and Severity Index (EASI) score to week 12 in comparison to placebo

- Number of Participants with Adverse Events used to assess Safety and tolerability after 12 weeks

Secondary Objective:

Timepoint(s) of evaluation of this end point: week 12

Secondary Outcome(s)

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

Secondary ID(s)

CQAW039X2201

Source(s) of Monetary Support

Novartis Pharma Services AG