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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552629
First Posted: March 13, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
January 26, 2012
March 13, 2012
February 23, 2017
January 5, 2012
August 28, 2013   (Final data collection date for primary outcome measure)
Change in Eczema Area and Severity Index(EASI) [ Time Frame: baseline, 12 weeks ]
Efficacy response will be assessed using EASI.
Same as current
Complete list of historical versions of study NCT01552629 on ClinicalTrials.gov Archive Site
  • Change in Investigator Global Assessment (IGA) for atopic dermatitis [ Time Frame: 6 weeks, 12 weeks ]
    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 [ Time Frame: 24 weeks ]
    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 [ Time Frame: 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
Same as current
Not Provided
Not Provided
 
A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients
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
The study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: QGE031
  • Drug: Placebo
  • Drug: Cyclosporine A
  • Experimental: Group 1 QGE031
    QGE031 will be administered as a subcutaneous dose q2 weeks
    Intervention: Drug: QGE031
  • Placebo Comparator: Group 2 Placebo
    A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks
    Intervention: Drug: Placebo
  • Experimental: Group 3 Cyclosporine A
    Cyclosporine A will be administered (as per label) for atopic dermatitis.
    Intervention: Drug: Cyclosporine A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 28, 2013
August 28, 2013   (Final data collection date for primary outcome measure)

Key Inclusion criteria:

  • Male and female patients 18 to 65 years of age inclusive (at the time of the screening visit), and who passed screening examinations by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
  • Presence of atopic dermatitis confirmed by itchy skin condition in the past 12 months (must have), plus three, or more, of the following:

    1. History of involvement of the skin creases (fronts of elbows, behind knees, fronts of ankles, around neck or around eyes)
    2. Personal history of asthma or hay fever
    3. History of generally dry skin in the past year
    4. Onset before age of 2 years
    5. Visible flexural dermatitis
  • Patients with an EASI score of ≥20 at screening and stable AD (not currently experiencing an acute flare of their AD or had a significant change in the extent of their disease or their treatment regimen in the month prior to enrollment)
  • Patients with a Total IgE in the range of 30 to 5000 IU/mL inclusive

Key exclusion criteria:

  • Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
  • Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means unless they were using a highly effective method of birth control:
  • Total abstinence
  • Male/female sterilization
  • Combination of any two of the following (a+b or a+c or b+c):

    1. Use of oral, injected or implanted hormonal methods of contraception
    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany
Netherlands
 
NCT01552629
CQGE031X2201
2011-002112-84 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP