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New asthma drug aims to stop attacks in severe cases

NCT ID NCT07098403

Disease control Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 3 trial tests a new drug called SHR-1905 for adults with severe asthma that is not well controlled by current treatments. The study will compare the drug to a placebo to see if it reduces asthma attacks and improves lung function. About 408 participants will take part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-1905 injection
What this could lead to
If successful, this could provide a new treatment option to reduce asthma attacks and improve breathing for people with severe uncontrolled asthma.
What could go wrong
This is a phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects are possible. It is not a cure.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 408 people

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

Started

Sep 2025

Expected to finish

Jun 2028

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 years and older

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. Age ≥ 18. 2. Documented physician-diagnosed asthma for at least 12 months. 3. Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months. 4. Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months. 5. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months. 6. Pre-BD FEV1 \< 80% predicted normal. 7. Objective evidence of asthma as documented. 8. Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS. 9. ACQ-6 score ≥ 1.5 at screening and on day of baseline. 10. ePRO adherence ≥ 70% in the 7 days prior to randomization. Exclusion Criteria: 1. Clinically significant pulmonary disease other than asthma. 2. History of cancer. 3. History of a clinically significant infection. 4. Current smokers or participants with smoking history ≥ 10 pack-yrs. 5. History of chronic alcohol or drug abuse within 12 months. 6. Hepatitis B, C or HIV. 7. Pregnant or breastfeeding. 8. History of anaphylaxis following any biologic therapy. 9. participant randomized in the current study or previous SHR-1905 studies.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

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

Asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510830, China

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