A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China

NCT06053801 | Completed

• 1 other identifier: CIGE025ECN01
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 10

Brief 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. The study period is 16 weeks which contains a 12-week treatment period and 4-week safety follow-up.

Conditions

Chronic Spontaneous Urticaria

Keywords

Chronic Spontaneous Urticaria; CSU; PASS; Omalizumab; Chinese

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (4)

• ISS7 (weekly Itch Severity Score)

  12 weeks

• UAS7 (Weekly Urticaria Severity Score)

  12 weeks

• Urticaria Control Test (UCT) score

  12 weeks

• Proportion of patients achieving Children's Dermatology Life Quality Index (CDLQI) 0 or 1 over time

  12 weeks

Study Arms (1)

Xolair

Chinese adolescents with Chronic Spontaneous Urticaria (CSU) inadequately controlled with H1 antihistamines

Other: Xolair

Interventions

Xolair OTHER

Prospective observational cohort study. There is no treatment allocation. Patients administered Xolair by prescription will be enrolled.

Also known as: Omalizumab

Xolair

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Chinese pediatric patients aged between 12 to less than 18 years and diagnosed with Chronic Spontaneous Urticaria.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Fuzhou, Fujian, 350025, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510091, China

Location

Novartis Investigative Site

Changsha, Hunan, 410008, China

Location

Novartis Investigative Site

Nantong, Jiangsu, 226000, China

Location

Novartis Investigative Site

Dalian, Liaoning, 116000, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310001, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310006, China

Location

Novartis Investigative Site

Wenzhou, Zhejiang, 325000, China

Location

Novartis Investigative Site

Beijing, 100069, China

Location

Novartis Investigative Site

Shanghai, 200443, China

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: February 16, 2024
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: February 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)