Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.

NCT ID: NCT01785602

Last Updated: 2015-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-11-30

Brief Summary

The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD).

Conditions

Atopic Dermatitis

Keywords

Atopic eczema; Skin Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

QAW039

Participants received QAW039 450 mg daily by mouth.

Group Type: EXPERIMENTAL

QAW039

Intervention Type: DRUG

Capsules

Placebo

Participants received matching placebo to QAW039.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsules

Interventions

QAW039

Capsules

Intervention Type: DRUG

Placebo

Capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months 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 ≥15 at screening and stable AD (not currently experiencing an acute flare of their AD).
• Patients that have been treated with topical corticosteroids or topical calcineurin inhibitors on at least one occasion, or could not use topical drugs (due to contraindications, side effects, etc.) and are candidates for or have previously received systemic treatment.

Exclusion Criteria

• History of hypersensitivity to any of the study drugs (including local anesthesia) or to drugs of similar chemical classes (CRTh2 antagonists)
• History of serious allergic reactions to any allergen, such as anaphylactic shock or life-threatening asthma, prior intubation, respiratory arrest, hospitalization due to asthma within the last 3 months or seizures as a result of asthma
• History of clinically significant ECG abnormalities or screening/baseline ECG that demonstrated clinical significant abnormalities which could affect patient safety or interpretation of study results
• History of long QT syndrome or whose QTc interval (Frederica's) was prolonged (>450 msec for males and females) at screening
• Use of topical prescription treatment (e.g., topical corticosteroids, calcineurin inhibitors, antibiotics, etc.) within two weeks prior to initial dosing of study drug. Patient use of emollients was encouraged
• Exception: For local atopic dermatitis flares during this 2-week interval, mild topical corticosteroids may be taken short term (up to one week)
• Recent previous systemic treatment with phototherapy, systemic antihistamines, immunosuppressive agents (e.g., cyclosporine, mycophenolate, or oral tacrolimus, including therapeutic proteins)
• Patients on maintenance immunotherapy who either began their allergen specific immunotherapy regimen or had a clinically relevant change to their immunotherapy within one month prior to granting informed consent
• Patients on high-dose statin therapy (>40 mg fluvastatin or 20 mg simvastatin, atorvastin, pravastatin, or rosuvastatin [10 mg if Asian])
• Excessive exposure to UV light in the three weeks prior to study start (screening), including tanning and sun beds and/or planning excessive sunbathing or beach holidays with associated sun bathing during the treatment period
• History of hypertrophic scarring
• Body mass index <17 or >40 kg/m2

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Phillip, Australian Capital Territory, Australia

Novartis Investigative Site

Benowa, Queensland, Australia

Novartis Investigative Site

Woolloongabba, Queensland, Australia

Novartis Investigative Site

Vienna, , Austria

Novartis Investigative Site

Brussels, , Belgium

Novartis Investigative Site

Leuven, , Belgium

Novartis Investigative Site

Liège, , Belgium

Novartis Investigative Site

Sofia, Bulgaria, Bulgaria

Novartis Investigative Site

Dresden, Germany, Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bonn, , Germany

Novartis Investigative Site

Münster, , Germany

Novartis Investigative Site

Amsterdam, , Netherlands

Novartis Investigative Site

Groningen, , Netherlands

Novartis Investigative Site

Utrecht, , Netherlands

Novartis Investigative Site

Bucharest, , Romania

Novartis Investigative Site

Durban, , South Africa

Countries

Australia; Austria; Belgium; Bulgaria; Germany; Netherlands; Romania; South Africa

Other Identifiers

2012-005321-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAW039X2201

Identifier Type: -

Identifier Source: org_study_id