Assessing the safety and effectiveness of Xolair® for adolescents with chronic spontaneous urticaria in China

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 study is testing if Xolair® can help Chinese teenagers with chronic hives feel better and improve their quality of life when other treatments aren't working.

Quick facts

• Study type: Observational
• Enrollment: 59 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 3 sites (Nantong, Jiangsu and 2 other locations)
• Trial ID: NCT06053801 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the safety and effectiveness of Xolair® in Chinese adolescents suffering from Chronic Spontaneous Urticaria (CSU) who continue to experience symptoms despite treatment with H1 antihistamines. Over a 16-week period, participants will undergo a 12-week treatment evaluation followed by a 4-week safety follow-up. The study will collect data during routine care visits, focusing on safety assessments and effectiveness measures such as itch severity and quality of life. No additional study-specific visits or procedures are required beyond standard clinical practice.

Who should consider this trial

Good fit: Ideal candidates are Chinese adolescents diagnosed with CSU who have not responded adequately to H1 antihistamine treatment.

Not a fit: Patients who are currently using other investigational drugs for CSU or have not been diagnosed with CSU may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Xolair® for managing CSU in adolescents, potentially improving treatment options.

How similar studies have performed: While this approach is based on existing treatments, the specific real-world evaluation of Xolair® in this population is novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

The patient should meet all of the following criteria:

1. 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®
2. 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.
3. Planned to receive Xolair® treatment according to the approved label in China at the time of screening.

Exclusion Criteria:

The patient should not meet any of the following criteria:

1. 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.
2. 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).
3. 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.

Where this trial is running

Nantong, Jiangsu and 2 other locations

• Novartis Investigative Site — Nantong, Jiangsu, China (Recruiting)
• Novartis Investigative Site — Hangzhou, Zhejiang, China (Recruiting)
• Novartis Investigative Site — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Chronic Spontaneous Urticaria; CSU; PASS; Omalizumab; Chinese