Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
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
1 other identifier
interventional
418
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2017
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2017
CompletedStudy Start
First participant enrolled
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2019
CompletedResults Posted
Study results publicly available
November 4, 2020
CompletedNovember 4, 2020
October 1, 2020
2.2 years
March 13, 2017
September 15, 2020
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment
The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0. Itch (Pruritus) Severity Score Scale: 0 = None 1. = Mild (minimal awareness, easily tolerated) 2. = Moderate (definite awareness, bothersome but tolerable) 3. = Severe (difficult to tolerate)
Baseline, Week 12
Secondary Outcomes (7)
Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment
Baseline, Week 12
Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment
Baseline, Week 12
Percentage of Patients With UAS7≤6 at Week 12
Week 12
Percentage of Complete Responders (UAS7 = 0) at Week 12
Week 12
Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12
Week 12
- +2 more secondary outcomes
Study Arms (3)
Omalizumab 300mg
EXPERIMENTALpatients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Omalizumab 150mg
EXPERIMENTALpatients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)
Placebo
PLACEBO COMPARATORpatients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Novartis Investigative Site
Beijing, Beijing Municipality, 100039, China
Novartis Investigative Site
Fuzhou, Fujian, 350025, China
Novartis Investigative Site
Guangzhou, Guangdong, 510630, China
Novartis Investigative Site
Nanning, Guangxi, 530021, China
Novartis Investigative Site
Harbin, Heilongjiang, 150001, China
Novartis Investigative Site
Wuhan, Hubei, 430022, China
Novartis Investigative Site
Wuhan, Hubei, 430030, China
Novartis Investigative Site
Changsha, Hunan, 410008, China
Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
Novartis Investigative Site
Suzhou, Jiangsu, 215006, China
Novartis Investigative Site
Wuxi, Jiangsu, China
Novartis Investigative Site
Shenyang, Liaoning, 110000, China
Novartis Investigative Site
Chengdu, Sichuan, 610041, China
Novartis Investigative Site
Ürümqi, Xinjiang, 830001, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310003, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310006, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310016, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Beijing, 100050, China
Novartis Investigative Site
Beijing, 100191, China
Novartis Investigative Site
Chongqing, 400011, China
Novartis Investigative Site
Chongqing, 400038, China
Novartis Investigative Site
Guangzhou, 510000, China
Novartis Investigative Site
Nanjing, 210042, China
Novartis Investigative Site
Shanghai, 200025, China
Novartis Investigative Site
Shanghai, 200040, China
Novartis Investigative Site
Shanghai, 200433, China
Related Publications (1)
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.
PMID: 33865434DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2017
First Posted
November 1, 2017
Study Start
April 26, 2017
Primary Completion
July 23, 2019
Study Completion
September 24, 2019
Last Updated
November 4, 2020
Results First Posted
November 4, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com