NCT06323213RecruitingPhase 3
Efficacy and Safety Study of 610 in Patients With Severe Asthma
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 14 Mar 2024
- Start date
- 24 Jun 2024
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Diseases
- Asthma
- NCT number
- NCT06323213
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 480
- From 24 Jun 2024 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe asthma exacerbation within 4 weeks prior to randomization.
- known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
Other illness
- Presence of a known pre-existing, clinically important lung condition other than asthma.
- Subjects with any eosinophilic diseases other than asthma.
- Known, pre-existing severe or clinically significant cardiovascular disease.
- Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- Subjects with allergy/intolerance to a monoclonal antibody.
Who the study is looking for
- Able to give written informed consent prior to participation in the study.
- Male or female adults ages 18 to 75 years old when signing the informed consent.
- Documented diagnosis of asthma for at least one year prior to screening.
- History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.