NCT06323213 Efficacy and Safety Study of 610 in Patients With Severe Asthma
| NCT ID | NCT06323213 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 480 participants in total. It began in 2024-06-24 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
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 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.
Contact & Investigator
Min Zhang
PRINCIPAL INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT06323213 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06323213 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 480 participants.
Is NCT06323213 currently recruiting?
Yes, NCT06323213 is actively recruiting participants. Contact the research team at zhouqinghong@3sbio.com for enrollment information.
Where is the NCT06323213 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06323213 clinical trial?
NCT06323213 is sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. The principal investigator is Min Zhang at Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 480 participants.
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