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New asthma drug shows promise in reducing severe attacks

NCT ID NCT05593250

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 medicine called SHR-1905 for people with severe asthma that is not well controlled by current treatments. About 260 adults will receive either the drug or a placebo to see if it reduces asthma attacks and improves breathing and quality of life. The goal is to find a safer and more effective way to manage severe asthma.

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

260 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Dec 2026

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. Male or female aged between 18 and 75 years (inclusive) 2. Weight ≥ 40 kg 3. Meet the diagnostic criteria for asthma and have a medical history of at least 1 year 4. Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization 5. At least one additional maintenance asthma controller with stable use for at least 3 months before randomization 6. At least 2 exacerbations within 12 months before screening 7. No birth plan and must agree to take effective contraceptive methods 8. Sign informed consent form voluntarily for the trial Exclusion Criteria: 1. Any clinically important pulmonary disease 2. Any disease other than asthma that may affect lung function 3. Any disease other than asthma related to elevation of eosinophils 4. Any immunodeficiency disease 5. Any clinically important serious cardiovascular diseases unstable or uncontrolled 6. Uncontrolled Hypertension 7. Uncontrolled Diabetes Mellitus 8. Any clinically important infections within 4 weeks before randomization 9. Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that may affect the evaluation of the subjects considered by the investigator 10. Any parasitic infections within 6 months before randomization 11. Malignancy diagnosed within 5 years before randomization 12. Abnormal laboratory tests during screening and baseline 13. Positive infectious disease test 14. Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject 15. Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years 16. Drug or alcohol abuse 17. Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study 18. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study 19. Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening 20. Any other circumstance inappropriate for participating in the clinical trial considered by the investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510163, China

More trials for these conditions

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