NCT01723072 (X-ACT) is a Phase 3 clinical trial of Omalizumab in Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01723072?

NCT01723072 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01723072?

Interventions in NCT01723072: Omalizumab, Placebo.

What condition does NCT01723072 study?

NCT01723072 studies Chronic Spontaneous Urticaria, Angioedema.

Is NCT01723072 still recruiting?

NCT01723072 is currently completed. Last updated 9 September 2020.

Are results published for NCT01723072?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-09-09 · How we verify

NCT01723072: X-ACT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Completed Phase 3 Results posted Last updated 9 September 2020

What this trial tests

Phase 3 trial testing Omalizumab in Chronic Spontaneous Urticaria in 91 participants. Completed in 9 May 2014.

Timeline

23 January 2013

Primary endpoint
9 May 2014

9 May 2014

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	91
Start date	23 January 2013
Primary completion	9 May 2014
Estimated completion	9 May 2014
Sites	25 locations across Germany

Drugs / interventions tested

Omalizumab (omalizumab) — full drug profile →
Placebo

Conditions studied

Chronic Spontaneous Urticaria — all drugs for Chronic Spontaneous Urticaria →
Angioedema — all drugs for Angioedema →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Chronic Spontaneous Urticaria or Angioedema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) Primary · Baseline, 4, 12, 20, 28 and 36 weeks

The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.

V3 (week 4)

Group	Value	95% CI
Omalizumab	-25.5	± 21.3
Placebo	-6.4	± 15.9

V5 (week 12)

Group	Value	95% CI
Omalizumab	-32.1	± 21.8
Placebo	-12.1	± 20.3

V7 (week 20)

Group	Value	95% CI
Omalizumab	-31.4	± 23.7
Placebo	-16.2	± 18.8

V9 (week 28)

Group	Value	95% CI
Omalizumab	-35.1	± 24.2
Placebo	-13.9	± 17.7

Follow-up (week 36)

Group	Value	95% CI
Omalizumab	-23.9	± 23.0
Placebo	-14.7	± 19.2

Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation) Secondary · Baseline, week 28; and the follow-up period (weeks 29-36)

Screening (Week -2 to -1)

Group	Value	95% CI
Omalizumab	5.2	± 3.9
Placebo	6.8	± 4.3

Treatment (Week 1 to 28)

Group	Value	95% CI
Omalizumab	14.6	± 19.5
Placebo	49.5	± 50.8

Follow-up (Week 29 to 36)

Group	Value	95% CI
Omalizumab	5.8	± 9.1
Placebo	12.8	± 16.2

Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes Secondary · Baseline to week 28

1st to 2nd episode

Group	Value	95% CI
Omalizumab	20	± 41.63
Placebo	7.8	± 14.29

2nd to 3rd episode

Group	Value	95% CI
Omalizumab	11.0	± 19.52
Placebo	7.2	± 10.16

3rd to 4th episode

Group	Value	95% CI
Omalizumab	26.4	± 50.73
Placebo	8.3	± 13.24

4th to 5th episode

Group	Value	95% CI
Omalizumab	14.9	± 23.87
Placebo	8.6	± 20.44

5th to 6th episode

Group	Value	95% CI
Omalizumab	14.2	± 20.54
Placebo	13.6	± 30.09

6th to 7th episode

Group	Value	95% CI
Omalizumab	11.2	± 22.11
Placebo	7.5	± 11.32

7th to 8th episode

Group	Value	95% CI
Omalizumab	18.1	± 29.41
Placebo	9.1	± 17.58

8th to 9th episode

Group	Value	95% CI
Omalizumab	10.7	± 15.05
Placebo	8.0	± 12.26

Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) Secondary · Baseline to week 28; and follow-up period (to week 36)

A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. min. score = 0 ; max. score= 100

Diary week 4

Group	Value	95% CI
Omalizumab	-17.7	± 20.0
Placebo	-5.0	± 18.2

Diary week 12

Group	Value	95% CI
Omalizumab	-19.0	± 22.4
Placebo	-9.0	± 22.8

Diary week 20

Group	Value	95% CI
Omalizumab	-21.3	± 21.6
Placebo	-16.9	± 21.0

Diary week 28

Group	Value	95% CI
Omalizumab	-20.6	± 21.5
Placebo	-10.8	± 21.3

Diary week 36

Group	Value	95% CI
Omalizumab	-9.6	± 18.4
Placebo	-15.3	± 20.8

Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) Secondary · week -2 to -1

data points per group

Acute swelling episode, Diameter <10cm

Group	Value	95% CI
Omalizumab	146
Placebo	165

Acute swelling episode, Diameter 10-20cm

Group	Value	95% CI
Omalizumab	54
Placebo	99

Acute swelling episode, Diameter >20cm

Group	Value	95% CI
Omalizumab	19
Placebo	46

unknown

Group	Value	95% CI
Omalizumab	12
Placebo	15

Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) Secondary · weeks 25 to 28

data points per group

Acute swelling episode, Diameter <10cm

Group	Value	95% CI
Omalizumab	31
Placebo	76

Acute swelling episode, Diameter 10-20cm

Group	Value	95% CI
Omalizumab	0
Placebo	94

Acute swelling episode, Diameter 20cm

Group	Value	95% CI
Omalizumab	0
Placebo	24

unknown

Group	Value	95% CI
Omalizumab	0
Placebo	12

Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) Secondary · weeks 33 to 36

data points per group

Acute swelling episode, Diameter <10cm

Group	Value	95% CI
Omalizumab	92
Placebo	90

Acute swelling episode, Diameter 10-20cm

Group	Value	95% CI
Omalizumab	28
Placebo	58

Acute swelling episode, Diameter >20cm

Group	Value	95% CI
Omalizumab	8
Placebo	19

unknown

Group	Value	95% CI
Omalizumab	17
Placebo	18

Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) Secondary · weeks -2 to -1

data points per group

Shortness of breath: No

Group	Value	95% CI
Omalizumab	203
Placebo	264

Shortness of breath: Slightly

Group	Value	95% CI
Omalizumab	13
Placebo	25

Shortness of breath: Moderately

Group	Value	95% CI
Omalizumab	7
Placebo	25

Shortness of breath: Severely

Group	Value	95% CI
Omalizumab	1
Placebo	7

Unknown

Group	Value	95% CI
Omalizumab	7
Placebo	4

Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) Secondary · weeks 25 to 28

data points per group

Shortness of breath: No

Group	Value	95% CI
Omalizumab	28
Placebo	195

Shortness of breath: Slightly

Group	Value	95% CI
Omalizumab	3
Placebo	5

Shortness of breath: Moderately

Group	Value	95% CI
Omalizumab	0
Placebo	5

Shortness of breath: Severely

Group	Value	95% CI
Omalizumab	0
Placebo	0

Unknown

Group	Value	95% CI
Omalizumab	0
Placebo	1

Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) Secondary · weeks 33 to 36

data points per group

Shortness of breath: No

Group	Value	95% CI
Omalizumab	127
Placebo	172

Shortness of breath: Slightly

Group	Value	95% CI
Omalizumab	14
Placebo	5

Shortness of breath: Moderately

Group	Value	95% CI
Omalizumab	1
Placebo	3

Shortness of breath: Severely

Group	Value	95% CI
Omalizumab	0
Placebo	1

Unknown

Group	Value	95% CI
Omalizumab	3
Placebo	4

Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) Secondary · baseline to week 28; and then follow-up to week 36

The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement. Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respe

week 4 (n=38,36)

Group	Value	95% CI
Omalizumab	-26.5	± 20.4
Placebo	-10.3	± 21.0

week 12 (n= 35, 29)

Group	Value	95% CI
Omalizumab	-37.4	± 23.8
Placebo	-20.4	± 27.4

week 20 (n=34,27)

Group	Value	95% CI
Omalizumab	-37.1	± 26.5
Placebo	-28.8	± 22

week 28 (n=34, 25)

Group	Value	95% CI
Omalizumab	-41.4	± 25.7
Placebo	-24.2	± 24.3

follow-up, week 36 (n=33,23)

Group	Value	95% CI
Omalizumab	-27.2	± 26.4
Placebo	-24.6	± 23.3

Rescue Medication During the Treatment Period Secondary · baseline to 28 weeks

Any rescue medication

Group	Value	95% CI
Omalizumab	25
Placebo	35

Any nsH1 - antihistamine rescue medication

Group	Value	95% CI
Omalizumab	19
Placebo	27

Any clemastine rescue medication

Group	Value	95% CI
Omalizumab	12
Placebo	26

Any corticosteroid rescue medication

Group	Value	95% CI
Omalizumab	5
Placebo	13

Betamethasone

Group	Value	95% CI
Omalizumab	2
Placebo	12

Prednisolone

Group	Value	95% CI
Omalizumab	3
Placebo	3

Prednisolone succinate

Group	Value	95% CI
Omalizumab	2
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 2.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Omalizumab

Serious: 4/44 (9%)

Deaths: —

Placebo

Serious: 2/47 (4%)

Deaths: —

Serious adverse events (11 terms)

Reaction	System	Omalizumab	Placebo
Alcohol poisoning	Injury, poisoning and procedural complications	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—
Intentional overdose	Injury, poisoning and procedural complications	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—
Ligament injury	Injury, poisoning and procedural complications	—	—
Pelvic fracture	Injury, poisoning and procedural complications	—	—
Sciatica	Nervous system disorders	—	—
Suicide attempt	Psychiatric disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Angioedema	Skin and subcutaneous tissue disorders	—	—
Hypertension	Vascular disorders	—	—

Other adverse events (15 terms — click to expand)

Reaction	System	Omalizumab	Placebo
Nasopharyngitis	Infections and infestations	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Hypertension	Vascular disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Pyrexia	General disorders	—	—
Sinusitis	Infections and infestations	—	—
Hepatic enzyme increased	Investigations	—	—
Dizziness	Nervous system disorders	—	—
Angioedema	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Alcohol poisoning, Femur fracture, Intentional overdose, Joint dislocation, Ligament injury, Pelvic fracture, Sciatica, Suicide attempt.

Data from ClinicalTrials.gov NCT01723072 adverse events section.

Sponsor's own description

This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial.
Staubach P, Metz M, Chapman-Rothe N, Sieder C, et al · · 2016 · cited 93× · PMID 27010957 · DOI 10.1111/all.12870
Omalizumab rapidly improves angioedema-related quality of life in adult patients with chronic spontaneous urticaria: X-ACT study data.
Staubach P, Metz M, Chapman-Rothe N, Sieder C, et al · · 2018 · cited 47× · PMID 29058822 · DOI 10.1111/all.13339
Chronic Spontaneous Urticaria: How to Measure It and the Need to Define Treatment Success.
Armstrong AW, Soong W, Bernstein JA. · · 2023 · cited 17× · PMID 37354293 · DOI 10.1007/s13555-023-00955-7
Efficacy of Different Dosing Regimens of IgE Targeted Biologic Omalizumab for Chronic Spontaneous Urticaria in Adult and Pediatric Populations: A Meta-Analysis.
Manzoor H, Razi F, Rasheed A, Sarfraz Z, et al · · 2022 · cited 5× · PMID 36554102 · DOI 10.3390/healthcare10122579
Oral Abstract Session OAS
· 2017

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01723072 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 9 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01723072.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01723072: X-ACT

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (11 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Omalizumab

Other recruiting trials for Chronic Spontaneous Urticaria

Other Novartis Pharmaceuticals trials

Verify against primary sources