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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: QGE031; Drug: Placebo; Drug: Cyclosporine A

• Registration Number: NCT01552629
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2013-08-28
• Study Completion: 2013-08-28
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 QGE031	QGE031	QGE031 will be administered as a subcutaneous dose q2 weeks
Group 2 Placebo	Placebo	A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks
Group 3 Cyclosporine A	Cyclosporine A	Cyclosporine A will be administered (as per label) for atopic dermatitis.

Primary Outcome Measures

Name	Time	Method
Change in Eczema Area and Severity Index(EASI)	baseline, 12 weeks	Efficacy response will be assessed using EASI.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	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)
Change in Investigator Global Assessment (IGA) for atopic dermatitis	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.
QGE031 plasma concentrations	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Kiel, Germany