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

NCT03468790 | Completed Phase 3

• 1 other identifier: C007AAIII
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Asthma, Allergic

Outcome Measures

Primary Outcomes (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.

  from baseline(0 week) to 24 weeks

Secondary Outcomes (9)

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

  from baseline(0 week) to 24 weeks

• time to the first asthma exacerbation during treatment period

  from baseline(0 week) to 24 weeks

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

  from baseline(0 week) to 24 weeks

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

  from baseline(0 week) to 24 weeks

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

  from baseline(0 week) to 24 weeks

Study Arms (2)

CMAB007 + Seretide/Symbicort + Ventolin

EXPERIMENTAL

CMAB007(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.

Drug: CMAB007; Drug: Symbicort; Drug: Seretide; Drug: Ventolin

Placebo + Seretide/Symbicort + Ventolin

PLACEBO COMPARATOR

Placebo is without active components of the study drug and used as same as the study drug.

Drug: Symbicort; Drug: Seretide; Drug: Ventolin; Drug: placebo

Interventions

CMAB007 DRUG

the study drug

Also known as: recombinant humanized anti-IgE monoclonal antibody

CMAB007 + Seretide/Symbicort + Ventolin

Symbicort DRUG

asthma-controlled drug

Also known as: budesonide and formoterol fumarate powder for inhalation

CMAB007 + Seretide/Symbicort + Ventolin; Placebo + Seretide/Symbicort + Ventolin

Seretide DRUG

asthma-controlled drug

Also known as: salmeterol xinafoate and fluticasone propionate

CMAB007 + Seretide/Symbicort + Ventolin; Placebo + Seretide/Symbicort + Ventolin

Ventolin DRUG

asthma rescue drug

Also known as: Salbutamol sulphate aerosol

CMAB007 + Seretide/Symbicort + Ventolin; Placebo + Seretide/Symbicort + Ventolin

placebo DRUG

No active components

Placebo + Seretide/Symbicort + Ventolin

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:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Biomabs Pharmaceutical Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510030, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

• 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.

  PMID: 41345745 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Budesonide; Inhalation; Fluticasone-Salmeterol Drug Combination; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Salmeterol Xinafoate; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes

Study Officials

• Nanshan Zhong, M.D.

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: placebo parallel-controlled

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 19, 2018
• Study Start: May 9, 2018
• Primary Completion: January 12, 2021
• Study Completion: March 9, 2021
• Last Updated: October 11, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)