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

February 20, 2017 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Novartis Investigative Site
  • France
      • Nice Cedex 3, France, 06202
        • Novartis Investigative Site
  • Germany
      • Bonn, Germany, 53105
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1 QGE031
QGE031 will be administered as a subcutaneous dose q2 weeks
Drug: QGE031
PLACEBO_COMPARATOR: Group 2 Placebo
A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks
Drug: Placebo
EXPERIMENTAL: Group 3 Cyclosporine A
Cyclosporine A will be administered (as per label) for atopic dermatitis.
Drug: Cyclosporine A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Eczema Area and Severity Index(EASI)
Time Frame: baseline, 12 weeks
Efficacy response will be assessed using EASI.
baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks, 12 weeks
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)
24 weeks
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 5, 2012

Primary Completion (ACTUAL)

August 28, 2013

Study Completion (ACTUAL)

August 28, 2013

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (ESTIMATE)

March 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGE031X2201
  • 2011-002112-84 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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