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

• ClinicalTrials.gov Identifier: NCT01785602
• Recruitment Status: Completed
• Results First Posted: December 15, 2015
• Last Update Posted: December 15, 2015
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: QAW039; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study Evaluating Efficacy and Safety of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
• Study Start Date: June 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: QAW039; Participants received QAW039 450 mg daily by mouth.	Drug: QAW039; Capsules
Placebo Comparator: Placebo; Participants received matching placebo to QAW039.	Drug: Placebo; Capsules

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, 12 weeks ]
   Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.

Secondary Outcome Measures :

1. Change From Baseline in Eczema Area and Severity Index [ Time Frame: Baseline, 4 weeks, 8 weeks ]
   Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key 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.

Key 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

Contacts and Locations

Locations

Australia, Australian Capital Territory

Novartis Investigative Site

Phillip, Australian Capital Territory, Australia, 2606

Australia, Queensland

Novartis Investigative Site

Benowa, Queensland, Australia, 4217

Novartis Investigative Site

Woolloongabba, Queensland, Australia, 4102

Austria

Novartis Investigative Site

Vienna, Austria

Belgium

Novartis Investigative Site

Bruxelles, Belgium, 1200

Novartis Investigative Site

Leuven, Belgium, 3000

Novartis Investigative Site

Liège, Belgium, 4000

Bulgaria

Novartis Investigative Site

Sofia, Bulgaria, 1612

Germany

Novartis Investigative Site

Berlin, Germany, 10098

Novartis Investigative Site

Berlin, Germany, 10117

Novartis Investigative Site

Bonn, Germany, 53105

Novartis Investigative Site

Dresden, Germany, 01307

Novartis Investigative Site

Muenster, Germany, 48149

Netherlands

Novartis Investigative Site

Amsterdam, Netherlands, 1105 AZ

Novartis Investigative Site

Groningen, Netherlands

Novartis Investigative Site

Utrecht, Netherlands, 3508 GA

Romania

Novartis Investigative Site

Bucharest, Romania, 011461

South Africa

Novartis Investigative Site

Durban, South Africa, 4001

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01785602
• Other Study ID Numbers: CQAW039X2201; 2012-005321-78 ( EudraCT Number )
• First Posted: February 7, 2013
• Results First Posted: December 15, 2015
• Last Update Posted: December 15, 2015
• Last Verified: November 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Atopic eczema; Skin Diseases

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases