A Multicenter, Randomized, Double-Blind, Positive Parallel Controlled Phase III Clinical Trial to Compare Omalizumab α(CMAB007) and Xolair® in Patients With Chronic Spontaneous Urticaria

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female patients 15 to 75 years old (both inclusive).

• Diagnosis of CSU refractory to H1AH, as defined by all of the following:

‣ Diagnosis of CSU at the time of screening, urticaria history ≥ 6 months at the time of randomization

⁃ The presence of itch and hives for ≥ 6 consecutive weeks within half year prior to randomization despite use of H1AH treatment during this time period;

⁃ UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1);

⁃ In-clinic UAS ≥ 4 on at least one of the screening visit days;

⁃ Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the screening visit and must have documented current use on the day of the initial screening visit.

• Voluntarily sign the informed consent form. Willing and able to complete a daily symptom diary for the duration of the study, and comply with the protocol requirements.

• Patients must not have had any missing diary entries in the 7 days prior to randomization.

• Women of childbearing age have negative pregnancy tests and are not in the lactation period at the time of screening. Both male and female patients must agree to practice contraception from the signing of informed consent to 6 months after the last dose of study drugs.

Locations
Other Locations
China
Huashan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jinhua Xu, PhD
xjhlcsy@163.com
021-60129299
Backup
Hui Tang, PhD
tanghuihuashan@163.com
021-60129299
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 392
Treatments
Experimental: CMAB007
patients received a dose of Omalizumab alpha (CMAB007) 300mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks(Day 1, Week 4 and Week 8) in the treatment period
Active_comparator: Xolair®
patients received a dose of Xolair® 300mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks(Day 1, Week 4 and Week 8) in the treatment period
Sponsors
Leads: Taizhou Mabtech Pharmaceutical Co.,Ltd

This content was sourced from clinicaltrials.gov