A randomized, double-blind, placebo controlled, parallel group, proof of concept study evaluating the efficacy,safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with moderate to severe atopic dermatitis

• Conditions: moderate to severe atopic dermatitis; MedDRA version: 14.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-002112-84-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-28
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male and female patients 18 to 65 years of age inclusive and having passed screening examinations by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
• Presence of atopic dermatitis:
• Itchy skin condition in the past 12 months (must have), 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 a Total IgE in the range of 30 to 5000 IU/mL inclusive.

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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pregnant or nursing (lactating) women
• Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in study protocol)
• Recent previous treatment with phototherapy, biological therapy, immunosupressive agents such as cyclosporine and mycophenolate (unless washout period applied, as defined in the study protocol)
• Treatment with drugs that induce or inhibit CYP3A4 and whose administration is known to affect the metabolism of cyclosporine
• Active, or recent history of clinically significant infection.
• History of keloid scarring.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified