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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01785602
Registration number
NCT01785602
Ethics application status
Date submitted
5/02/2013
Date registered
7/02/2013
Date last updated
15/12/2015
Titles & IDs
Public title
Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.
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Scientific 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
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Secondary ID [1]
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2012-005321-78
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Secondary ID [2]
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CQAW039X2201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - QAW039
Treatment: Drugs - Placebo
Experimental: QAW039 - Participants received QAW039 450 mg daily by mouth.
Placebo comparator: Placebo - Participants received matching placebo to QAW039.
Treatment: Drugs: QAW039
Capsules
Treatment: Drugs: Placebo
Capsules
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Eczema Area and Severity Index (EASI)
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Assessment method [1]
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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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Timepoint [1]
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Baseline, 12 weeks
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Secondary outcome [1]
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Change From Baseline in Eczema Area and Severity Index
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Assessment method [1]
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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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Timepoint [1]
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Baseline, 4 weeks, 8 weeks
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Eligibility
Key inclusion criteria
Key
* 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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
1/11/2014
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Sample size
Target
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Accrual to date
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Final
103
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Recruitment in Australia
Recruitment state(s)
ACT,QLD
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Recruitment hospital [1]
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Novartis Investigative Site - Phillip
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Recruitment hospital [2]
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Novartis Investigative Site - Benowa
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Recruitment hospital [3]
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Novartis Investigative Site - Woolloongabba
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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4217 - Benowa
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment outside Australia
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Austria
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Vienna
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Liège
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Bulgaria
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Sofia
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Muenster
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Utrecht
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Romania
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Bucharest
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Country [14]
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South Africa
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State/province [14]
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Durban
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT01785602
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01785602
Download to PDF