Clinical trial NCT06053801: A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Spontaneous Urticaria
Keywords: Chronic Spontaneous Urticaria
CSU
PASS
Omalizumab
Chinese
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 59
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese pediatric patients aged between 12 to less than 18 years and diagnosed with Chronic Spontaneous Urticaria.

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.

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.

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.

Primary outcomes:
measure: AE/AESI/SAE type and frequency
timeFrame: 16 weeks
Secondary outcomes:
measure: ISS7 (weekly Itch Severity Score)
timeFrame: 12 weeks
measure: UAS7 (Weekly Urticaria Severity Score)
timeFrame: 12 weeks
measure: Urticaria Control Test (UCT) score
timeFrame: 12 weeks
measure: Proportion of patients achieving Children's Dermatology Life Quality Index (CDLQI) 0 or 1 over time
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nantong
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Shanghai
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: