Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma. (NCT03468790) | Clinical Trial Compass
CompletedPhase 3
Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma.
China393 participantsStarted 2018-05-09
Plain-language 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.
Who can participate
Age range
15 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the mean number of asthma exacerbations per patient during the 24-week treatment period
. 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.
Exclusion criteria
. 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.