Clinical trial NCT03328897: Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
Official title: A Phase III Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Spontaneous Urticaria
Keywords: Chronic spontaneous urticaria
ISS7
UAS7
omalizumab
China
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.

Detailed description: This was a randomized, multicenteric, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients of refractory CSU who remained symptomatic despite approved-dosed H1AH treatment.

The study consisted of three distinct epochs over 24 weeks: Screening epoch (Day -28 to Day -1), Randomized treatment epoch (Day 1 to Week 12) and Post-treatment follow-up epoch (Week 12 to Week 20). Patients were randomized into three treatment groups (omalizumab 300 mg s.c. omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio, stratified by latent tuberculosis (TB) status at Baseline (Yes/No).

On Day 1, eligible patients were randomly assigned to receive omalizumab (150 mg or 300 mg) or placebo by subcutaneous (s.c.) injection every 4 weeks (on Day 1, Week 4, and Week 8) during the 12-week double-blind randomized-treatment epoch. Patients visited the study center at 4-week intervals. Patients were instructed to stay on the same CSU H1AH treatment at stable dose that they were using during the pre-randomization period during the randomized treatment epoch. They were allowed to use diphenhydramine as rescue medication during all epochs. The last dose of the study drug during the randomized-treatment epoch was administered at Week 8 study visit, however, the last assessment was done at Week 12.

After the completion of the 12-week randomized-treatment epoch, all patients entered an 8-week post-treatment follow-up epoch.

Eligibility criteria: Main Inclusion Criteria:

* Symptomatic CSU patients with CSU diagnosis for at least 6 months.
* Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the Day -14 screening visit
* Patients must have documented current use on the day of the initial screening visit

Main Exclusion Criteria

* Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria)
* Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer

Primary outcomes:
measure: Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment
timeFrame: Baseline, Week 12
measure: Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment
timeFrame: Baseline, Week 12
measure: Percentage of Patients With UAS7≤6 at Week 12
timeFrame: Week 12
measure: Percentage of Complete Responders (UAS7 = 0) at Week 12
timeFrame: Week 12
measure: Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12
timeFrame: Week 12
measure: Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment
timeFrame: Week 12
measure: Time to ISS7 MID Response by Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Fuzhou
country: China
facility: Novartis Investigative Site
state: Fujian
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Nanning
country: China
facility: Novartis Investigative Site
state: Guangxi
city: Harbin
country: China
facility: Novartis Investigative Site
state: Heilongjiang
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Wuxi
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Urumqi
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
city: Nanjing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Bi XD, Lu BZ, Pan XX, Liu S, Wang JY. Adjunct therapy with probiotics for chronic urticaria in children: randomised placebo-controlled trial. Allergy Asthma Clin Immunol. 2021 Apr 17;17(1):39. doi: 10.1186/s13223-021-00544-3.