moderate to severe atopic dermatitis MedDRA version: 16.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Code: QGE031
Pharmaceutical Form: Solution for injection
Current Sponsor code: QGE031
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 140-
Pharmaceutical fo
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.Active or recent history of clinically significant infection. Other exclusion criteria are included in the clinical study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Change in Eczema Area and Severity Index(EASI). Efficacy response will be assessed using EASI. ;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. •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) •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 ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •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. •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) •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 ;Timepoint(s) of evaluation of this end point: • Change in Investigator Global Assessment --> 6 weeks, 12 weeks • Number of participants with adverse events --> 24 weeks • QGE031 plasma concentrations --> 24 weeks. 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 | — |
Countries
Austria, Germany, Netherlands
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed