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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552629
• Other study ID #: CQGE031X2201
• Secondary ID: 2011-002112-84
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2012
• Last updated: February 20, 2017
• Start date: January 5, 2012
• Est. completion date: August 28, 2013

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 28, 2013
• Est. primary completion date: August 28, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• QGE031

• Placebo

• Cyclosporine A

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Vienna
France	Novartis Investigative Site	Nice Cedex 3
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Eczema Area and Severity Index(EASI)	Efficacy response will be assessed using EASI.	baseline, 12 weeks
Secondary	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.	6 weeks, 12 weeks
Secondary	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)	24 weeks
Secondary	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	24 weeks

External Links

•   Abstract for CQGE031X2201
•   Results for CQGE031X2201 from the Novartis Clinical Trials Website