Clinical trial NCT01785602: Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic eczema
Skin Diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change From Baseline in Eczema Area and Severity Index
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Phillip
country: Australia
facility: Novartis Investigative Site
state: Australian Capital Territory
city: Benowa
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: