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Chronic Spontaneous UrticariaPhase 3NCT06365879

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

A Phase 3 study testing CMAB007 and Xolair in people with Chronic Spontaneous Urticaria, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 15 to 75 years
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
CMAB007 and Xolair
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
1 siteChina
Study dates
18 Jun 2024to 10 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Hematological abnormalities: hemoglobin<100g/L, platelets<100*10^9/L, white blood cells<3.0*10^9/L, neutrophils<1.5*10^9/L.
  • Patients with serological results positive for human immunodeficiency virus, treponema pallidum, hepatitis B or hepatitis C. (1) Hepatitis B surface antigen positive patients will be excluded; (2) Hepatitis B core antibody positive: 1) Hepatitis B surface antibody positive patients can be included in this study; 2) Patients with negative hepatitis B surface antibodies need to be tested for HBV-DNA (if HBV DNA is negative, patients can be included in this study; If the HBV DNA is positive, the patient will be excluded).
  • Participated in clinical trials of other drugs within 3 months or 5 drug half-lives (whichever is longer) prior to screening.
  • History of alcohol or drug abuse, or failure to take medication as prescribed.
  • Pregnant or nursing (lactating) women.
  • Currently taking or plan to take medications prohibited by the protocol at screening.
  • Other conditions deemed by investigator as unsuitable for this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital

    Shanghai

Other trials in China

About this study

Official title: 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

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

Read the detailed description

The study will consist of three periods: a screening period (up to 2 weeks), a 12-week treatment period and a 8-week follow-up period. The total duration of the study is up to 22 weeks. After signing informed consent, subjects who meet the inclusion criteria and do not meet the exclusion criteria will be assigned to the CMAB007 or Xolair® in a 1:1 ratio. The subjects will treated with three doses of CMAB007 or Xolair®, subcutaneous injection every four weeks in the treatment period. After the end of the treatment period, an 8-week safety follow-up was conducted. The type and dosage of H1 antihistamines remained stable in the study.

Being tested
CMAB007, Xolair
Keywords
Chronic spontaneous urticaria, omalizumab
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMAB007Drug

    Also called Omalizumab alpha

    300mg, SC, Q4W

  • XolairDrug

    Also called Omalizumab

    300mg, SC, Q4W

Study groups in NCT06365879
Study groupRoleWhat they receive
CMAB007Experimentalpatients 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
Receives: Drug: CMAB007
Xolair®Active comparatorpatients 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
Receives: Drug: Xolair

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Week 12

Secondary outcomes (21)

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

    UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.

    Measured: Week 12

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

    Hives Severity Score (HSS), defined by number of hives, were recorded by the patient once daily in their Diary, on a scale of 0 (none) to 3 (intense/severe). A weekly number of hives score (NHS7) 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. The complete hives response was defined as NHS7=0.

    Hives Severity Score scale:

    • 0= None
    • 1=Mild (< 20 hives/24 hours)
    • 2=Moderate (20-50 hives/24 hours)
    • 3=Severe (>50 hives/24 hours)

    Measured: Week 12

  3. Time to ISS7 MID Response by Week 12

    The ISS7 MID response was defined as a reduction from Baseline in ISS7 of ≥ 5 points. Time to ISS7 MID response was the time (in weeks) from the date of the first dose to the date where ISS7 MID response was first achieved during Week 1 to Week 12.

    Measured: Week 12

  4. Percentage of Patients With UAS7≤6 at Week 12

    UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Week 12 responders were defined as patients who achieved an absolute UAS7 ≤ 6 at Week 12.

    Measured: Week 12

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

    The ISS7 MID response was defined as a reduction from Baseline in ISS7 of ≥ 5 points.

    Measured: Week 12

  6. Change From Baseline of Urticaria Control Test (UCT) at Week 12

    The urticaria control score (UCT) was a retrospective assessment of disease control over the past 4 weeks. The assessment contents four-items: physical symptoms of the urticaria (itch, hives[welts], and or swelling), quality of life, treatment control and overall disease control. The score range for each item is 0 to 4, and the total score is the sum of the four questions.The possible score range of the UCT is 0 to 16. A score of 16 indicates complete disease control. A score of <12 on identifies patients with poorly controlled chronic urticaria (CU), and a score of ≥12 identifies those with well-controlled symptoms.

    Measured: Week 12

  7. Percentage of Patients With UCT≥12 at Week 12

    The possible range of the UCT is 0 to 16. A higher UCT indicates better control. The total score ≥12 indicates that urticaria is well controlled.

    Measured: Week 12

  8. Percentage of Complete Controls (UCT=16) at Week 12

    The possible range of the UCT is 0 to 16. A higher UCT indicates better control. The total score=16 indicates that urticaria is complete controlled.

    Measured: Week 12

  9. Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12

    Dermatology life quality index (DLQI) is a 10-item dermatology- specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as separate scores for the following domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment. Each domain had 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.

    Measured: Week 12

  10. Percentage of Complete Responders (UAS7=0) at Week 12

    UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Complete responders are defined as participants who achieved UAS7 = 0.

    Measured: Week 12

  11. Percentage of Angioedema-free Days From Week 4 to Week 12

    The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded "No" to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.

    Measured: Week 4 to Week 12

  12. Incidence of adverse events

    Number of patients reporting at least one adverse event in the study. An adverse event is defined as any untoward medical occurrence in a clinical trial participant graded according to the common terminology criteria for adverse events (CTCAE) v.5.0 criteria,including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs

    Measured: Week 20

  13. Immunogenicity

    Percentage of anti-drug antibody and neutralizing antibody in the study. Subjects with a positive antibody response to Omalizumab were determined to test neutralizing antibody.

    Measured: Week 20

  14. AUC0-t

    AUC0-t, the area under the concentration-time curve from time zero to the time of the last quantifiable concentration, will be analyzed using a non-atrioventricular model.

    Measured: Week 20

  15. AUC0-inf

    AUC0-inf, the area under the concentration-time curve from time zero to infinity, will be analyzed using a non-atrioventricular model.

    Measured: Week 20

  16. Half time

    Half time will be analyzed using a non-atrioventricular model.

    Measured: Week 20

  17. Cmax

    Cmax is the maximum concentration.

    Measured: Week 20

  18. Tmax

    Tmax is the time of the maximum concentration.

    Measured: Week 20

  19. Clearance Rate

    Clearance rate will be analyzed using a non-atrioventricular model.

    Measured: Week 20

  20. Apparent Volume of Distribution

    Apparent Volume of Distribution will be analyzed using a non-atrioventricular model.

    Measured: Week 20

  21. Level of Total IgE and Free IgE

    Pharmacodynamics

    Measured: Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start18 Jun 2024
  3. Primary completion29 Jan 2026
  4. Study completion10 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06365879
Sponsor's protocol ID
CMAB007-003
Status last verified
Sep 2026
First submitted
7 Apr 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CMAB007 and Xolair in people with Chronic Spontaneous Urticaria, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline of the Itch Severity Score (ISS7) Score At Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06365879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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