Chronic Spontaneous UrticariaNCT06053801
A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 10 sites in China.
Trial summary
This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Xolair
- How many people
- 55 participants
- Where
- 10 sitesChina
- Study dates
- 16 Feb 2024to 10 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Chinese pediatric patients aged between 12 to less than 18 years and diagnosed with Chronic Spontaneous Urticaria.
Who may be able to join
- The patient should meet all of the following criteria:
- Diagnosed with CSU refractory to H1-AH at approved doses as defined by all of the following:
- The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to enrollment despite current use of second-generation H1-AH (at locally approved doses)
- UAS7 score (range 0-42) ≥ 16 and ISS7 (range 0-21) ≥ 8 as captured in the UPDD during the 7 days prior to treatment initiation with Xolair®
- Willing and able to complete a daily symptom Diary (UPDD) for the duration of the study, and having no more than 3 missing diary entries in the screening period.
- Planned to receive Xolair® treatment according to the approved label in China at the time of screening.
Who cannot join
- The patient should not meet any of the following criteria:
- Use of other investigational drugs for CSU treatment within 5 half-lives, or within 30 days (for small molecules) prior to screening or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
- History of hypersensitivity to any of the anti-IgE drugs or their excipients or to drugs of similar classes (i.e. to murine, chimeric, or human antibodies).
- Any other skin disease associated with chronic itching that might influence, in the investigators opinion, the study evaluations and results. (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
- Other protocol-defined inclusion/exclusion criteria may apply at the end.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Novartis Investigative Site
Beijing, 100069
Novartis Investigative Site
Changsha, Hunan, 410008
Novartis Investigative Site
Dalian, Liaoning, 116000
Novartis Investigative Site
Fuzhou, Fujian, 350025
Novartis Investigative Site
Guangzhou, Guangdong, 510091
Novartis Investigative Site
Hangzhou, Zhejiang, 310001
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Nantong, Jiangsu, 226000
Novartis Investigative Site
Shanghai, 200443
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
About this study
Official title: A Real-world, Prospective, Multicenter Study of Safety and Effectiveness of Xolair® (Omalizumab) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Chinese Adolescents Inadequately Controlled With H1 Antihistamines
This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment. The study period is 16 weeks which contains a 12-week treatment period and 4-week safety follow-up.
Read the detailed description
The study period is 16 weeks which contains a 12-week treatment effect evaluation period and 4-week safety follow up. The primary objective is to evaluate the safety of Xolair® in a real-world setting in Chinese adolescent patients with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment over a 16-week study period. The secondary objectives are to evaluate the effectiveness (measured by ISS7, UAS7, UCT) of Xolair® and the quality of life (measured by CDLQI) of Chinese adolescent patients over a 12-week treatment period. Data will be collected in conjunction with routine care visits at the site, at Week 4, 8, 12 (recommended scheduled visits). Routine clinical assessments will be conducted, and safety information will be collected. Safety information includes AE/SAE collection, including but not limited to lab tests, vital signs, weight, physical examination etc. No extra study visits, examinations, laboratory tests or procedures other than activities performed in clinical practice will be mandated.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Xolair
- Keywords
- Chronic Spontaneous Urticaria, CSU, PASS, Omalizumab, Chinese
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XolairOther
Also called Omalizumab
Prospective observational cohort study. There is no treatment allocation. Patients administered Xolair by prescription will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Xolair | Chinese adolescents with Chronic Spontaneous Urticaria (CSU) inadequately controlled with H1 antihistamines Receives: Other: Xolair |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE/AESI/SAE type and frequency
The type and frequency of adverse event (AE), adverse events of special interest (AESI) and serious adverse event (SAE) will be used as variables to evaluate the primary objective. AESI terms include Anaphylaxis, Churg Strauss Syndrome, Arterial Thromboembolic Events and Malignant neoplasms.
Measured: 16 weeks
Secondary outcomes (4)
ISS7 (weekly Itch Severity Score)
A weekly itch score is derived by adding up the average daily ISS of the 7 days preceding the visit. ISS is ranged on a scale of 0 (none) to 3 (intense/severe), therefore, the possible range of the ISS7 is 0 to 21 where higher scores indicate more intense itch.
Measured: 12 weeks
UAS7 (Weekly Urticaria Severity Score)
The number of hives and intensity of itch score will be recorded by the patient in Urticaria Patient Daily Diary (UPDD), on a scale of 0 (none) to 3 (intense/severe). The Urticaria Severity Score (UAS) is a composite score of the number of wheals (hives) (Hives Severity Scores, HSS); and the severity of the itch (Itch Severity Scores, ISS). A weekly hives score (HSS7) is derived by adding up the average daily HSS of the 7 days preceding the visit. The possible range of the HSS7 is therefore 0 to 21. A weekly itch score (ISS7) is derived by adding up the average daily ISS of the 7 days preceding the visit. The possible range of the ISS7 is therefore 0 to 21. The UAS7 is the sum of the HSS7 score and the ISS7 score. The possible range of the weekly UAS7 score is 0 to 42 (highest activity).
Measured: 12 weeks
Urticaria Control Test (UCT) score
Frequency and percentage will be provided for patients who achieved well-controlled CSU (defined as a UCT score ≥12) at Week 12.
The UCT is a 4-item Patient Reported Outcome measure developed to assess disease control in patients with Chronic Urticaria specifically Chronic Spontaneous Urticaria and Chronic Inducible Urticaria. It has a 7 days recall period and patients respond with how much they were bothered by their urticaria symptoms, what is the impact on QoL, how often the treatment did not control their urticaria and their overall perception of disease control. Each question can be scored on a scale from 0 to 4 and the overall score ranges from 0 (no control) to 16 (maximum control). The cut-off value for disease control was established at 12. Patients with a score above 12 are considered controlled. A minimally important difference of 3 points was validated as reflective of a clinically relevant change of control
Measured: 12 weeks
Proportion of patients achieving Children's Dermatology Life Quality Index (CDLQI) 0 or 1 over time
The Children's Dermatology Life Quality Index is a 10-item general dermatology disability index designed to assess health-related quality of life in pediatric subjects aged 4 to 16 years. It is self-explanatory and may be completed by the child with assistance from parents or caregivers as necessary. The 10 questions cover six areas of daily activities including symptoms and feelings, leisure, school or holidays, personal relationships, sleep and treatment. The questions are based on the preceding week to permit accurate recall. Each question is answered on a 4-point Likert scale scored from 0 to 3. These are added to give a minimum score of 0 and maximum score of 30. A higher CDLQI score indicates a greater degree of QoL impairment. The CDLQI questionnaire will be completed by all patients independent of age, to ensure consistency.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start16 Feb 2024
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053801
- Sponsor's protocol ID
- CIGE025ECN01
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world, Prospective, Multicenter Study of Safety and Effectiveness of Xolair® (Omalizumab) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Chinese Adolescents Inadequately Controlled With H1 Antihistamines
- ClinicalTrials.gov ID
- NCT06053801
- Acronym / sponsor ID
- CIGE025ECN01
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Chronic Spontaneous Urticaria, CSU, PASS, Omalizumab, Chinese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment. The study period is 16 weeks which contains a 12-week treatment period and 4-week safety follow-up.
Detailed description
The study period is 16 weeks which contains a 12-week treatment effect evaluation period and 4-week safety follow up. The primary objective is to evaluate the safety of Xolair® in a real-world setting in Chinese adolescent patients with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment over a 16-week study period. The secondary objectives are to evaluate the effectiveness (measured by ISS7, UAS7, UCT) of Xolair® and the quality of life (measured by CDLQI) of Chinese adolescent patients over a 12-week treatment period. Data will be collected in conjunction with routine care visits at the site, at Week 4, 8, 12 (recommended scheduled visits). Routine clinical assessments will be conducted, and safety information will be collected. Safety information includes AE/SAE collection, including but not limited to lab tests, vital signs, weight, physical examination etc. No extra study visits, examinations, laboratory tests or procedures other than activities performed in clinical practice will be mandated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xolair | – | Other: XolairChinese adolescents with Chronic Spontaneous Urticaria (CSU) inadequately controlled with H1 antihistamines |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Chinese pediatric patients aged between 12 to less than 18 years and diagnosed with Chronic Spontaneous Urticaria.
Key inclusion criteria (6 listed)
- Diagnosed with CSU refractory to H1-AH at approved doses as defined by all of the following:
- Willing and able to complete a daily symptom Diary (UPDD) for the duration of the study, and having no more than 3 missing diary entries in the screening period.
- Planned to receive Xolair® treatment according to the approved label in China at the time of screening.
Key exclusion criteria (5 listed)
- Use of other investigational drugs for CSU treatment within 5 half-lives, or within 30 days (for small molecules) prior to screening or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
- History of hypersensitivity to any of the anti-IgE drugs or their excipients or to drugs of similar classes (i.e. to murine, chimeric, or human antibodies).
- Any other skin disease associated with chronic itching that might influence, in the investigators opinion, the study evaluations and results. (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
- Other protocol-defined inclusion/exclusion criteria may apply at the end.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XolairAlso: OmalizumabProspective observational cohort study. There is no treatment allocation. Patients administered Xolair by prescription will be enrolled. | Other | Xolair |
Primary outcome
AE/AESI/SAE type and frequency
Time frame: 16 weeks
The type and frequency of adverse event (AE), adverse events of special interest (AESI) and serious adverse event (SAE) will be used as variables to evaluate the primary objective. AESI terms include Anaphylaxis, Churg Strauss Syndrome, Arterial Thromboembolic Events and Malignant neoplasms.
4 secondary outcomes
ISS7 (weekly Itch Severity Score)
Time frame: 12 weeks
UAS7 (Weekly Urticaria Severity Score)
Time frame: 12 weeks
Urticaria Control Test (UCT) score
Time frame: 12 weeks
Proportion of patients achieving Children's Dermatology Life Quality Index (CDLQI) 0 or 1 over time
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE/AESI/SAE type and frequency (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.