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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01785602
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785602


Locations
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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01785602     History of Changes
Other Study ID Numbers: CQAW039X2201
2012-005321-78 ( EudraCT Number )
First Posted: February 7, 2013    Key Record Dates
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:
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Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs