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 (CQGE031X2201)
- Conditions
- atopic dermatitis10040790
- Registration Number
- NL-OMON37121
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 12
* Male and female patients 18 to 65 (inclusive) years of age.
* Presence of atopic dermatitis confirmed by:
* Itchy skin condition in the past 12 months (must have), plus three, or more, of the following:
o History of involvement of the skin creases (fronts of elbows, behind knees, fronts of ankles, around neck or around eyes)
o Personal history of asthma or hay fever
o History of generally dry skin in the past year
o Onset before age of 2 years
o Visible flexural dermatitis
* EASI score of *20 at screening and stable AD (on current treatment regimen in the month prior to enrollment).
* Total IgE in the range of 30 to 5000 IU/mL inclusive.
* Pregnant or nursing women.
* Women of child-bearing potential, unless using adequate contraceptive measures.
* Known hypersensitivity to any constituents of the study drugs, to murine, chimeric or human antibodies, or to drugs of similar chemical classes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>EASI at week 12.</p><br>
- Secondary Outcome Measures
Name Time Method <p>IGA, 12 weeks, EASI and IGA 6 weeks, adverse events, PK, PD, immunogenicity,<br /><br>specific IgE, IgE autoantibodies and free IgE, Patient Reported Outcomes.</p><br>