Trial · NCT01785602

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

NCT01785602, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-12-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis. Trials, record NCT01785602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01785602

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.
NCT number: NCT01785602
Status: Completed
Phases: Phase 2
Enrollment: 103 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Atopic Dermatitis
Interventions: QAW039, Placebo
First posted: 2013-02-07
Last updated: 2015-12-15
Other registries' IDs: eudract:2012-005321-78
Results first posted: 2015-12-15

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Eczema Area and Severity Index (EASI)	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	Change From Baseline in Eczema Area and Severity Index	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Eczema Area and Severity Index (EASI)	Baseline, 12 weeks	All randomized participants	Score on a scale	MEAN
SECONDARY	Change From Baseline in Eczema Area and Severity Index	Baseline, 4 weeks, 8 weeks	All randomized participants	Score on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Eczema Area and Severity Index (EASI)	QAW039		-8.65	Standard Error 0.010	Score on a scale
Change From Baseline in Eczema Area and Severity Index (EASI)	Placebo		-6.95	Standard Error 0.017	Score on a scale
Change From Baseline in Eczema Area and Severity Index	QAW039	Week 4	-6.22	Standard Error 0.010	Score on a scale
Change From Baseline in Eczema Area and Severity Index	Placebo	Week 4	-5.89	Standard Error 0.017	Score on a scale
Change From Baseline in Eczema Area and Severity Index	QAW039	Week 8	-7.49	Standard Error 0.010	Score on a scale
Change From Baseline in Eczema Area and Severity Index	Placebo	Week 8	-5.61	Standard Error 0.017	Score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	QAW039	76
Overall Study	STARTED	Placebo	27
Overall Study	COMPLETED	QAW039	63
Overall Study	COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	QAW039	13
Overall Study	NOT COMPLETED	Placebo	9

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	QAW039	4	76
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	27
other	Abdominal pain upper	Gastrointestinal disorders	QAW039	3	76
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	2	27
other	Diarrhoea	Gastrointestinal disorders	QAW039	10	76
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	27
other	Nausea	Gastrointestinal disorders	QAW039	6	76
other	Nausea	Gastrointestinal disorders	Placebo	3	27
other	Fatigue	General disorders	QAW039	5	76
other	Fatigue	General disorders	Placebo	1	27

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	QAW039
Total, all-cause mortality	Placebo
Total, other adverse events	QAW039	44	76
Total, other adverse events	Placebo	16	27
Total, serious adverse events	QAW039	1	76
Total, serious adverse events	Placebo	4	27

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
QAW039 vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01785602

GET https://conductscience.org/api/trials/v1/NCT01785602/events?page=2

API reference For AI assistants