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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

QGE031

Placebo

Cyclosporine A

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Atopic eczema, Skin Diseases, QGE031

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Group 1 QGE031

Group 2 Placebo

Group 3 Cyclosporine A

Arm Description

QGE031 will be administered as a subcutaneous dose q2 weeks

A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks

Cyclosporine A will be administered (as per label) for atopic dermatitis.

Outcomes

Primary Outcome Measures

Change in Eczema Area and Severity Index(EASI)

Efficacy response will be assessed using EASI.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01552629

First Posted

January 26, 2012

Last Updated

February 20, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01552629

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 5, 2012 (Actual)

Primary Completion Date

August 28, 2013 (Actual)

Study Completion Date

August 28, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Atopic dermatitis, Atopic eczema, Skin Diseases, QGE031

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 QGE031

Arm Type

Experimental

Arm Description

QGE031 will be administered as a subcutaneous dose q2 weeks

Arm Title

Group 2 Placebo

Arm Type

Placebo Comparator

Arm Description

A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks

Arm Title

Group 3 Cyclosporine A

Arm Type

Experimental

Arm Description

Cyclosporine A will be administered (as per label) for atopic dermatitis.

Intervention Type

Drug

Intervention Name(s)

QGE031

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Cyclosporine A

Primary Outcome Measure Information:

Title

Change in Eczema Area and Severity Index(EASI)

Description

Efficacy response will be assessed using EASI.

Time Frame

baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Change in Investigator Global Assessment (IGA) for atopic dermatitis

Description

Participants dermatitis will be visually assessed and an IGA score will be determined by the Investigator using a prespecified evaluation criteria.

Time Frame

6 weeks, 12 weeks

Title

Number of participants with adverse events

Description

Adverse events will be determined by observation and non-leading questioning of patients, and by measuring safety parameters (electrocardiograms, clinical laboratory, blood pressure)

Time Frame

24 weeks

Title

QGE031 plasma concentrations

Description

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

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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): Use of oral, injected or implanted hormonal methods of contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Vienna

Country

Austria

Facility Name

Novartis Investigative Site

City

Nice Cedex 3

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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