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Asthma, AllergicPhase 3NCT03468790

Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma.

A Phase 3 study testing CMAB007, Symbicort and Seretide in people with Asthma, Allergic, run by Shanghai Biomabs Pharmaceutical Co., Ltd. at 2 sites 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 is a multi-centre, randomized, double-blind，placebo parallel-controlled phase III study to evaluate the efficacy and safety of CMAB007 (recombinant humanized anti-immunoglobulin E(IgE) monoclonal antibody for injection) to treat asthma patients who remain not adequately controlled despite Med/high ICS plus LABA… Read more about this study

Who is it for?
Ages 15 to 75 years
Conditions the study is for
Asthma, Allergic
What is being tested?
CMAB007, Symbicort and Seretide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
393 participants
Where
2 sitesChina
Study dates
9 May 2018to 9 Mar 2021
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

  • Signed and dated informed consent prior to any study assessment;
  • Age 15-75 years inclusive, female or male;
  • Diagnosed as asthma according to the guideline for the prevention and treatment of bronchial asthma in China (version 2016), with duration for more than 1 years;
  • Have had at least one severe asthma exacerbations(requiring systemic steroid use) in the previous one year;
  • At screening, serum total IgE level 60-1500IU/ml and body weight 20-150kg.
  • Receiving seretide(fluticasone>250ug/day) or symbicort(budesonide>400ug/day) for at least 3 months and stable dose for at least 4 weeks prior to screening. Asthma symptom control level is still partly controlled or uncontrolled. Detailed drugs and usage are one of the following: Seretide 50/250ug 1 inhalation bid；Seretide 50/500ug 1 inhalation bid；Symbicort 160/4.5ug 2 inhalations bid or Symbicort 320/9ug 1 inhalation bid.
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  • None of other asthma controller medications other than seretide or symbicort including systemic steroid, leukotriene modifiers, theophylline, histamine1 receptor blockers, anticholinergic drugs, traditional Chinese medicine and so on have been used 2 weeks prior to screening.
  • At screening, FEV1 < 80% of the predicted normal value.
  • At screening, laboratory tests results should meet all of the following: hemoglobin≥80g/l；3*10^9/l≤white blood cell≤10*10^9/l；platelet≥75*10^9/l；liver function(glutamic-pyruvic transaminase, glutamic-oxalacetic transaminase and total bilirubin)≤2*upper limit of normal value；renal function≤1.5*upper limit of normal value.
  • At screening, pregnant test is negative,or not lactating, for women of child-bearing potential. Effective methods of contraception will be maintained throughout the study and 6 months after the study.
  • Can understand and complete questionnaires correctly, complete PEF and patient diary correctly, and be followed up according to scheduled table.

Who cannot join

  • History of critical asthma exacerbations，such as tracheal intubation or intensive care unit admission.
  • Currently smoker, or a former smoker with a smoking history > 10 pack-years(defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
  • Have elevated serum IgE levels for other causes other than allergens, such as parasite infections, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome and so on.
  • Desensitization therapy or immunosuppressant agents such as cyclosporine, methotrexate and gold preparation during 3 months prior to screening.
  • Biological agents such as monoclonal antibody including investigational biological drugs during 6 months prior to screening.
  • Vaccinated live/attenuated virus or bacterial vaccines, or intravenous used immunoglobulin G, during 4 weeks prior to screening.
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  • History of bronchial thermoplasty for asthma during 12 months prior to screening.
  • Use of any anti-IgE monoclonal antibody including Xolair for asthma during 12 months prior to screening.
  • Respiratory infections（such as pneumonia,upper respiratory tract infection，etc）or large surgeries during 4 weeks prior to screening.
  • Combined with other pulmonary diseases, such as chronic obstructive pulmonary disease, bronchiectasis, pulmonary interstitial fibrosis, etc.
  • History of malignancies other than squamous cell carcinoma or basal cell carcinoma of the skin and carcinoma in situs of cervix with complete excision and no evidence of recurrences.
  • Acquired immune deficiency syndrome or human immunodeficiency virus infection patients.
  • History of malignant or proliferative diseases of the lymphatic system such as lymphoma, or there are symptoms and signs indicating lymphatic proliferative diseases, or splenomegaly (≥2cm under the ribs).
  • With uncontrolled hypertension(systolic pressure ≥160 or diastolic pressure ≥100 in millimeters of mercury) at screening.
  • With severe, progressive or uncontrolled hepatic, renal, gastrointestinal, cardio-cerebral vascular, hematopoietic，genitourinary, endocrine, nervous and immunological medical conditions, or other conditions that investigators think the patient not suitable for this study.
  • Have a history of drug or alcohol abuse or poor compliance of drugs.
  • With known hypersensitivity to human immunoglobulin, anti-IgE monoclonal antibody for injection or components.
  • Have attended other clinical trials of investigational drugs, or within 30 days or 5 half-lives of enrollment, whichever is longer.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510030

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

Official title: A Multi-centre, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Anti-IgE Monoclonal Antibody to Treat Allergic Asthma Patients Not Adequately Controlled Despite Med/High ICS/LABA.

This is a multi-centre, randomized, double-blind，placebo parallel-controlled phase III study to evaluate the efficacy and safety of CMAB007 (recombinant humanized anti-immunoglobulin E(IgE) monoclonal antibody for injection) to treat asthma patients who remain not adequately controlled despite Med/high ICS plus LABA in China. Following a screening period of up to 2 weeks and run-in period of 4 weeks, randomized patients will enter a 24-week treatment period with CMAB007 or placebo. Efficacy and safety will be assessed at 4-week intervals during the treatment period.

Read the detailed description

Approximately 400 asthma patients with an increased serum total IgE level(60-1500 international unit(IU)/ml) and uncontrolled receiving medium to high dose inhaled corticosteroid (ICS) plus long-acting β2-agonist(LABA) will be randomised in about 43 sites in China. They will be administered CMAB007 or placebo at a ratio of 2:1 for 24 weeks. During the whole study, all subjects will be on regularly fixed combination of med/high ICS and LABA (budesonide and formoterol fumarate powder for inhalation or salmeterol xinafoate and fluticasone propionate powder for inhalation). They should complete PEF measurement and patient diary daily and be assessed every 4 weeks. Spirometry, questionnaires, laboratory tests and so on will be performed. At selected sites, about 45 patients will be enrolled in a sub-study to assess the pharmacokinetic and pharmacodynamic characterises of CMAB007. Anti-drug antibody (ADA) will be sampled at V1, V2 and V7 too.

Being tested
CMAB007, Symbicort, Seretide, Ventolin, placebo
Medical subject headings
Asthma

What participants receive

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

  • CMAB007Drug

    Also called recombinant humanized anti-IgE monoclonal antibody

    the study drug

  • SymbicortDrug

    Also called budesonide and formoterol fumarate powder for inhalation

    asthma-controlled drug

  • SeretideDrug

    Also called salmeterol xinafoate and fluticasone propionate

    asthma-controlled drug

  • VentolinDrug

    Also called Salbutamol sulphate aerosol

    asthma rescue drug

  • placeboDrug

    No active components

Study groups in NCT03468790
Study groupRoleWhat they receive
CMAB007 + Seretide/Symbicort + VentolinExperimentalCMAB007(recombinant humanized anti-IgE monoclonal antibody for injection ) will be at a fixed dose determined by the subjects' total IgE and weight at V0. All the subjects will be treated subcutaneously for 24 weeks. The 4-week total dose is 0.016mg/kg/IgE(IU/ml), administered every 2 or 4 weeks, for the subjects with total IgE level 60-700IU/ml. If the total IgE level is 700-1500IU/ml, they will be administered 375mg every 2 weeks. Symbicort(Budesonide and formoterol fumarate powder for inhalation) or Seretide (salmeterol xinafoate and fluticasone propionate powder for inhalation) will be used 1/2 inhalations bid as asthma-controlled drug during the whole study. Ventolin (Salbutamol sulphate aerosol) will be used as asthma rescue drug.
Receives: Drug: CMAB007; Drug: Symbicort; Drug: Seretide; Drug: Ventolin
Placebo + Seretide/Symbicort + VentolinPlacebo comparatorPlacebo is without active components of the study drug and used as same as the study drug.
Receives: Drug: Symbicort; Drug: Seretide; Drug: Ventolin; Drug: placebo

What is being measured

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

  1. the mean number of asthma exacerbations per patient during the 24-week treatment period

    Asthma exacerbation is defined by a worsening of asthma symptoms resulting in: 1.out-planned outpatient visit; 2.use of systemic and/or nebulized inhaled corticosteroids; 3.emergency room visit; 4. hospitalization.

    Measured: from baseline(0 week) to 24 weeks

Secondary outcomes (9)

  1. the proportion of patients with asthma exacerbations during the 24-week treatment period

    the number of patients with at least one exacerbations divided by the total number of patients.

    Measured: from baseline(0 week) to 24 weeks

  2. time to the first asthma exacerbation during treatment period

    the time from baseline to the first asthma exacerbation

    Measured: from baseline(0 week) to 24 weeks

  3. change from baseline in asthma symptom scores(daytime, nocturnal and total) over the 24-week treatment period

    mean asthma symptom scores(daytime, nocturnal and total): (pre-treatment - post-treatment)/pre-treatment *100%

    Measured: from baseline(0 week) to 24 weeks

  4. change from baseline in Asthma Control Test(ACT) over the 24-week treatment period

    ACT total score: (pre-treatment - post-treatment)/pre-treatment *100%

    Measured: from baseline(0 week) to 24 weeks

  5. change from baseline in Asthma Quality of Life Questionnaire(AQLQ) over the 24-week treatment period

    AQLQ total score and threshold score: (pre-treatment - post-treatment)/pre-treatment *100%

    Measured: from baseline(0 week) to 24 weeks

  6. investigator's and patient's Global Evaluation of Treatment Effectiveness(GETE) over 16 and 24-week treatment period

    GETE score at week 16 and 24

    Measured: from baseline(0 week) to 16 and 24 weeks

  7. change from baseline in rescue medication use over the 24-week treatment period

    mean rescue medication use(puff/day): (pre-treatment - post-treatment)/pre-treatment *100%

    Measured: from baseline(0 week) to 24 weeks

  8. change from baseline in lung function parameters(FEV1,FVC and FEV1/FVC) over the 24-week treatment period

    FEV1,FVC and FEV1/FVC values: (post-treatment - pre-treatment)/pre-treatment *100%

    Measured: from baseline(0 week) to 24 weeks

  9. change from baseline in mean peak expiratory flow(PEF) over the 24-week treatment period

    mean PEF value: (post-treatment - pre-treatment)/pre-treatment *100%

    Measured: from baseline(0 week) to 24 weeks

Timeline

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

  1. First posted19 Mar 2018
  2. Study start9 May 2018
  3. Primary completion12 Jan 2021
  4. Study completion9 Mar 2021

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
Model description
placebo parallel-controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468790
Sponsor's protocol ID
C007AAIII
Status last verified
Mar 2020
First submitted
7 Mar 2018
Last updated
11 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lai K, Yan Z, Qian D, Zhang X, Bian T, Dai X, Li H, Lin L, Wang J, Wang L, Yang J, Hu Y, Li H, Nie X, Jin F, Li G, Sun S, Xu F, Zhao H, Chen Y, Liu C, Zhu H, Li J, Guo Y, Zhong N. Benefits of CMAB007 in Chinese Patients Having Inadequately Controlled Moderate/Severe Asthma With Increased Total IgE: A Randomized Phase 3 Trial. Allergy Asthma Immunol Res. 2026 Jan;18(1):39-54. doi: 10.4168/aair.2026.18.1.39. Epub 2025 Nov 26.

    PubMed 41345745

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CMAB007, Symbicort and Seretide in people with Asthma, Allergic, run by Shanghai Biomabs Pharmaceutical Co., Ltd. at 2 sites 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 11 inclusion and 18 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

the mean number of asthma exacerbations per patient during the 24-week treatment period (time frame: from baseline(0 week) to 24 weeks). 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 NCT03468790, which also lists 1 linked publication.

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 11 Oct 2021.

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