Trial · NCT03328897

Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

NCT03328897, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2020-11-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria. Trials, record NCT03328897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03328897

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Trial

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

Title: Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
NCT number: NCT03328897
Status: Completed
Phases: Phase 3
Enrollment: 418 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Chronic Spontaneous Urticaria
Interventions: Omalizumab, Placebo
First posted: 2017-11-01
Last updated: 2020-11-04
Results first posted: 2020-11-04

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment	Baseline, Week 12	The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0. Itch (Pruritus) Severity Score Scale: 0 = None 1. = Mild (minimal awareness, easily tolerated) 2. = Moderate (definite awareness, bothersome but tolerable) 3. = Severe (difficult to tolerate)
Secondary	Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment	Baseline, Week 12	UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.
Secondary	Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment	Baseline, Week 12	Hives Severity Score (HSS), defined by number of hives, were recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly number of hives score (NHS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21. The complete hives response was defined as NHS7 = 0. Hives Severity Score scale: 0 - None * Mild (1-6 hives/12 hours) * Moderate (7-12 hives/12 hours) * Severe (\>12 hives/12 hours)
Secondary	Percentage of Patients With UAS7≤6 at Week 12	Week 12	UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Week 12 responders were defined as patients who achieved an absolute UAS7 ≤ 6 at Week 12. A patient with missing data at Week 12 was imputed as a responder if the patient was a responder at Week 10 and Week 11, otherwise as a non-responder.
Secondary	Percentage of Complete Responders (UAS7 = 0) at Week 12	Week 12	UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Complete responders are defined as participants who achieved UAS7 = 0.
Secondary	Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12	Week 12	The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0. Itch (Pruritus) Severity Score Scale: 0 = None 1. = Mild (minimal awareness, easily tolerated) 2. = Moderate (definite awareness, bothersome but tolerable) 3. = Severe (difficult to tolerate) The ISS7 MID response was defined as a reduction from Baseline in ISS7 of ≥ 5 points.
Secondary	Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment	Week 12	Dermatology life quality index (DLQI) is a 10-item dermatology- specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as separate scores for the following domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment. Each domain had 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
Secondary	Time to ISS7 MID Response by Week 12	12 weeks	The ISS7 MID response was defined as a reduction from Baseline in ISS7 of ≥ 5 points. Time to ISS7 MID response was the time (in weeks) from the date of the first dose to the date where ISS7 MID response was first achieved during Week 1 to Week 12.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment	Baseline, Week 12	Full Analysis Set	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment	Baseline, Week 12	Full Analysis Set	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment	Baseline, Week 12	Full analysis set	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Patients With UAS7≤6 at Week 12	Week 12	Full analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Complete Responders (UAS7 = 0) at Week 12	Week 12	Full analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12	Week 12	Full analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment	Week 12	Full analysis set	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Time to ISS7 MID Response by Week 12	12 weeks	Full analysis set	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group33

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

Outcome	Group	Value	Spread	Units
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment	Omalizumab 300mg	-10.11	Standard Error 0.430	Score on a scale
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment	Omalizumab 150mg	-9.66	Standard Error 0.424	Score on a scale
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment	Placebo	-5.87	Standard Error 0.604	Score on a scale
Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment	Omalizumab 300mg	-21.82	Standard Error 0.895	Score on a scale
Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment	Omalizumab 150mg	-20.74	Standard Error 0.882	Score on a scale
Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment	Placebo	-11.62	Standard Error 1.258	Score on a scale
Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment	Omalizumab 300mg	-11.68	Standard Error 0.492	Score on a scale
Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment	Omalizumab 150mg	-11.11	Standard Error 0.485	Score on a scale
Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment	Placebo	-5.76	Standard Error 0.690	Score on a scale
Percentage of Patients With UAS7≤6 at Week 12	Omalizumab 300mg	81		Participants

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow21

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

Period	Milestone	Group	Participants
Randomized-treatment Epoch	STARTED	Omalizumab 300mg	168
Randomized-treatment Epoch	STARTED	Omalizumab 150mg	167
Randomized-treatment Epoch	STARTED	Placebo	83
Randomized-treatment Epoch	Full Analysis Set (FAS)	Omalizumab 300mg	167
Randomized-treatment Epoch	Full Analysis Set (FAS)	Omalizumab 150mg	167
Randomized-treatment Epoch	Full Analysis Set (FAS)	Placebo	83
Randomized-treatment Epoch	COMPLETED	Omalizumab 300mg	152
Randomized-treatment Epoch	COMPLETED	Omalizumab 150mg	162
Randomized-treatment Epoch	COMPLETED	Placebo	81
Randomized-treatment Epoch	NOT COMPLETED	Omalizumab 300mg	16

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events126

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 discomfort	Gastrointestinal disorders	Omalizumab 300 mg	0	167
other	Abdominal discomfort	Gastrointestinal disorders	Omalizumab 150 mg	4	167
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	2	83
other	Diarrhoea	Gastrointestinal disorders	Omalizumab 300 mg	2	167
other	Diarrhoea	Gastrointestinal disorders	Omalizumab 150 mg	4	167
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	83
other	Pyrexia	General disorders	Omalizumab 300 mg	5	167
other	Pyrexia	General disorders	Omalizumab 150 mg	4	167
other	Pyrexia	General disorders	Placebo	1	83
other	Hepatic function abnormal	Hepatobiliary disorders	Omalizumab 300 mg	0	167

1 to 10 of 126Source ClinicalTrials.gov

See all 126 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Omalizumab 300 mg	0	167
Total, all-cause mortality	Omalizumab 150 mg	0	167
Total, all-cause mortality	Placebo	0	83
Total, other adverse events	Omalizumab 300 mg	84	167
Total, other adverse events	Omalizumab 150 mg	79	167
Total, other adverse events	Placebo	43	83
Total, serious adverse events	Omalizumab 300 mg	5	167
Total, serious adverse events	Omalizumab 150 mg	5	167
Total, serious adverse events	Placebo	3	83

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33865434	DERIVED

Source PubMed

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 comparisons0

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

None in this release.

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.

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Read this trial from software.

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