Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: QAW039
Drug: Placebo
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title QAW039 Placebo
Hide Arm/Group Description Participants received QAW039 450 mg daily by mouth. Participants received matching placebo to QAW039.
Period Title: Overall Study
Started 76 27
Completed 63 18
Not Completed 13 9
Reason Not Completed
Withdrawal by Subject             2             0
Lost to Follow-up             1             1
Adverse Event             3             5
Administrative problems             7             3
Arm/Group Title QAW039 Placebo Total
Hide Arm/Group Description Participants received QAW039 450 mg daily by mouth. Participants received matching placebo to QAW039. Total of all reporting groups
Overall Number of Baseline Participants 76 27 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 27 participants 103 participants
35.5  (13.08) 38.7  (9.95) 36.3  (12.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 27 participants 103 participants
Female
27
  35.5%
12
  44.4%
39
  37.9%
Male
49
  64.5%
15
  55.6%
64
  62.1%
1.Primary Outcome
Title Change From Baseline in Eczema Area and Severity Index (EASI)
Hide Description 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.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title QAW039 Placebo
Hide Arm/Group Description:
Participants received QAW039 450 mg daily by mouth.
Participants received matching placebo to QAW039.
Overall Number of Participants Analyzed 76 27
Mean (Standard Error)
Unit of Measure: Score on a scale
-8.65  (0.010) -6.95  (0.017)
2.Secondary Outcome
Title Change From Baseline in Eczema Area and Severity Index
Hide Description 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.
Time Frame Baseline, 4 weeks, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title QAW039 Placebo
Hide Arm/Group Description:
Participants received QAW039 450 mg daily by mouth.
Participants received matching placebo to QAW039.
Overall Number of Participants Analyzed 76 27
Mean (Standard Error)
Unit of Measure: Score on a scale
Week 4 -6.22  (0.010) -5.89  (0.017)
Week 8 -7.49  (0.010) -5.61  (0.017)
Time Frame Serious adverse events were collected from day 1 until 4 weeks after end of study (week 20)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QAW039 Placebo
Hide Arm/Group Description Participants received QAW039 450 mg daily by mouth. Participants received matching placebo to QAW039.
All-Cause Mortality
QAW039 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
QAW039 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/76 (1.32%)   4/27 (14.81%) 
Cardiac disorders     
Atrial fibrillation  1  1/76 (1.32%)  0/27 (0.00%) 
Infections and infestations     
Diverticulitis  1  0/76 (0.00%)  1/27 (3.70%) 
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  0/76 (0.00%)  3/27 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
QAW039 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   44/76 (57.89%)   16/27 (59.26%) 
Gastrointestinal disorders     
Abdominal pain  1  4/76 (5.26%)  1/27 (3.70%) 
Abdominal pain upper  1  3/76 (3.95%)  2/27 (7.41%) 
Diarrhoea  1  10/76 (13.16%)  2/27 (7.41%) 
Nausea  1  6/76 (7.89%)  3/27 (11.11%) 
General disorders     
Fatigue  1  5/76 (6.58%)  1/27 (3.70%) 
Infections and infestations     
Nasopharyngitis  1  11/76 (14.47%)  1/27 (3.70%) 
Oral herpes  1  4/76 (5.26%)  1/27 (3.70%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/76 (1.32%)  2/27 (7.41%) 
Nervous system disorders     
Dizziness  1  3/76 (3.95%)  2/27 (7.41%) 
Headache  1  7/76 (9.21%)  4/27 (14.81%) 
Hypoaesthesia  1  0/76 (0.00%)  2/27 (7.41%) 
Tension headache  1  1/76 (1.32%)  2/27 (7.41%) 
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  24/76 (31.58%)  9/27 (33.33%) 
Pruritus  1  3/76 (3.95%)  2/27 (7.41%) 
Vascular disorders     
Hot flush  1  0/76 (0.00%)  2/27 (7.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01785602     History of Changes
Other Study ID Numbers: CQAW039X2201
2012-005321-78 ( EudraCT Number )
First Submitted: February 5, 2013
First Posted: February 7, 2013
Results First Submitted: November 11, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015