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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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.
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
Secondary ID [1] 0 0
2012-005321-78
Secondary ID [2] 0 0
CQAW039X2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Eczema Area and Severity Index (EASI)
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [1] 0 0
Change From Baseline in Eczema Area and Severity Index
Timepoint [1] 0 0
Baseline, 4 weeks, 8 weeks

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.

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
ACT,QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Phillip
Recruitment hospital [2] 0 0
Novartis Investigative Site - Benowa
Recruitment hospital [3] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Bonn
Country [8] 0 0
Germany
State/province [8] 0 0
Dresden
Country [9] 0 0
Germany
State/province [9] 0 0
Muenster
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
Netherlands
State/province [11] 0 0
Groningen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Utrecht
Country [13] 0 0
Romania
State/province [13] 0 0
Bucharest
Country [14] 0 0
South Africa
State/province [14] 0 0
Durban

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01785602
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01785602