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New asthma drug shows promise in late-stage trial

NCT ID NCT06680947

Disease control Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new antibody drug (called 610) for adults with severe asthma that is not well controlled by standard inhalers. About 225 participants will receive either the drug or a placebo to see if it improves lung function and reduces asthma attacks over 52 weeks. The drug targets a specific immune cell protein (IL-5) to reduce airway inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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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Conditions

The condition(s) this trial relates to.

asthma T2-high asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.