A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients

• 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-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-04
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

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

Inclusion Criteria

1. Adult patients 18 to 65 years
2. 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

3.Patients with a Total IgE in the range of 30 to 5000 IU/mL inclusive.

Other inclusion criteria are available in the clinical study protocol.
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

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

Other exclusion criteria are included in the clinical study protocol.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: • Change in Eczema Area and Severity Index(EASI). Efficacy response will be assessed using EASI.<br><br><br><br>;Secondary Objective: •Change in Investigator Global Assessment (IGA) for atopic dermatitis. Participants dermatitis will be visually assessed and an IGA score will be determined by the Investigator using a prespecified evaluation criteria.<br><br><br>•Number of participants with adverse events. Adverse events will be determined by observation and non-leading questioning of patients, and by measuring safety parameters (electrocardiograms, clinical laboratory, blood pressure)<br><br><br>•QGE031 plasma concentrations. Blood samples will be collected on Day 1(predose),15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, and 169 for determination of QGE031 serum levels<br><br><br><br>;Primary end point(s): •Change in Eczema Area and Severity Index(EASI) ;Timepoint(s) of evaluation of this end point: Time Frame: baseline, 12 weeks