To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria

NCT06365879 | Recruiting Phase 3

• 1 other identifier: CMAB007-003
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Spontaneous Urticaria

Keywords

Chronic spontaneous urticaria; omalizumab

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of the Itch Severity Score (ISS7) Score At Week 12

  The severity of the itch was recorded by the patient twice daily in their Diary, 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)

  Week 12

Secondary Outcomes (21)

• Change From Baseline of Urticaria Activity Score (UAS7) At Week 12

  Week 12

• Change From Baseline of Number of Hives Score (NHS7) At Week 12

  Week 12

• Time to ISS7 MID Response by Week 12

  Week 12

• Percentage of Patients With UAS7≤6 at Week 12

  Week 12

• Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12

  Week 12

Study Arms (2)

CMAB007

EXPERIMENTAL

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

Drug: CMAB007

Xolair®

ACTIVE COMPARATOR

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

Drug: Xolair

Interventions

CMAB007 DRUG

300mg, SC, Q4W

Also known as: Omalizumab alpha

CMAB007

Xolair DRUG

300mg, SC, Q4W

Also known as: Omalizumab

Xolair®

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Chronic inducible urticaria. This includes but is not limited to: dermatographism (factitious urticaria), cold, heat, solar, delayed pressure, aquagenic, cholinergic or contact urticarias. Any of the following diseases, which may have symptoms of urticaria and/or angioedema: urticarial vasculitis, erythema multiforme, mastocytosis, hereditary or acquired angioedema, etc.
• Suffer from other chronic pruritic dermatosis that may confound the results: atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, psoriasis, etc.
• CSU patients who had difficulty breathing episodes due to angioedema in the past six months.
• Previous treatment with omalizumab within one year prior to signing the informed consent.
• Hypersensitivity to omalizumab, study drug excipients or other biosimilars, or have a history of severe drug allergy or anaphylactic shock.
• Use systemic or local corticosteroids, hydroxychloroquine, methotrexate, cyclosporin or cyclophosphamide, and tripterygium within 30 days prior to screening; Use compound glycyrrhizin, total glucosides of paeony and other traditional Chinese medicine within 14 days before screening; Use H2 antihistamines and leukotriene modulators within 7 days before screening; Use H1 antihistamines exceeding protocol requirements within 3 days prior to screening; Use other CSU drugs (including but not limited to biologics, small molecule drugs) within 3 months or 5 drug half-lives (whichever is longer) prior to screening.
• Patients with a stool examination positive for ova or parasites at screening.
• Active infections requiring treatment at screening, include but not limited to pulmonary infection, tuberculosis and acute bronchial asthma.
• Have received live attenuated vaccine or intravenous immunoglobulin within 30 days before screening; Live attenuated vaccines are planned or received at any time during the study period.
• History of malignancy of any organ or system within 5 years prior to screening (except for basal cell carcinoma, Cervical carcinoma in situ)
• Evidence of cardiovascular disease (e.g., myocardial infarction, unstable angina, acute coronary syndrome, NYHA Grade III/VI left ventricular failure, arrhythmias and uncontrolled hypertension within 6 months prior to screening), neurological, psychiatric, pulmonary, renal, liver, endocrine, metabolic, hematological, gastrointestinal, or immune deficiencies that the investigators believe may compromise subjects' safety or interfere study results.
• Presence of clinically significant examination, include but not limited:
• Abnormal liver function \[AST or ALT ≥ 2 x ULN, or total bilirubin ≥ 2 x ULN\];
• Abnormal renal function \[elevated serum creatinine \> 1.5 x ULN\] or estimated glomerular filtration rate (eGFR) \< 45 mL/min (using Cockcroft-Gault equation);
• Abnormal ECG, e.g.,corrected QTcF interval (using Fridericia's correction formula) ≥470ms (female) or 450ms (male), II-III degree atrioventricular block, tachyarrhythmia requiring treatment.

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Huashan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Jinhua Xu, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Hui Tang, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhua Xu, PhD

CONTACT

021-60129299; xjhlcsy@163.com

Hui Tang, PhD

CONTACT

021-60129299; tanghuihuashan@163.com

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: April 7, 2024
• First Posted: April 15, 2024
• Study Start: June 18, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)