Efficacy and Safety Study of 610 in Patients With Severe Asthma
Recruiting
Phase 3Interventional Study
Asthma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
480 (estimated)
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for adults with severe asthma to test a treatment called 610. Participants will need to have a history of asthma and be on certain medications.
Are You a Good Fit for This Trial?
You may be able to join if
I can provide written consent to join the trial.
I am between 18 and 75 years old.
I have been diagnosed with asthma for at least one year.
I have been treated for asthma with specific medications for at least 6 months.
You may not be able to join if
I have a serious lung condition other than asthma.
I have had a severe asthma attack in the last 4 weeks.
I have any eosinophilic diseases other than asthma.
I have severe heart disease.
I have other serious medical conditions that are not under control.
I have active Hepatitis B, Hepatitis C, or HIV.
I am allergic to monoclonal antibodies.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Able to give written informed consent prior to participation in the study.
2. Male or female adults ages 18 to 75 years old when signing the informed consent.
3. Documented diagnosis of asthma for at least one year prior to screening.
4. History of physician-diagnosed asthma …
Inclusion Criteria:
1. Able to give written informed consent prior to participation in the study.
2. Male or female adults ages 18 to 75 years old when signing the informed consent.
3. Documented diagnosis of asthma for at least one year prior to screening.
4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
Exclusion Criteria:
1. Presence of a known pre-existing, clinically important lung condition other than asthma.
2. Severe asthma exacerbation within 4 weeks prior to randomization.
3. Subjects with any eosinophilic diseases other than asthma.
4. Known, pre-existing severe or clinically significant cardiovascular disease.
5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
7. Subjects with allergy/intolerance to a monoclonal antibody.
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