NCT06680947Active, not recruitingPhase 2
A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 225 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- 20 Dec 2024
- Primary completion date
- Feb 2027
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Diseases
- Asthma
- NCT number
- NCT06680947
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 225
- From 20 Dec 2024 to the primary completion date, 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
- 2\. Severe asthma exacerbation within 4 weeks prior to randomization.
- 5\. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
Other illness
- 1\. Presence of a known pre-existing, clinically important lung condition other than Asthma.
- 3\. Subjects with any eosinophilic diseases other than asthma.
- 4\. Known, pre-existing severe or clinically significant cardiovascular disease.
- 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.
Who the study is looking for
- 1\. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
- 2\. Female and male aged 18 to 75 years.
- 3\. Diagnosed with asthma for ≥12 months that meet GINA.
- 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.
- 5\. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
- 6\. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.
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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.