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New antibody drug shows promise for severe asthma sufferers

NCT ID NCT05472324

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called TQC2731 in 205 adults with severe asthma that is not well controlled by standard treatments. The drug is a lab-made antibody that blocks a protein involved in asthma inflammation. Participants received either one of three doses of TQC2731 or a placebo by injection every 4 weeks for about a year. The main goal was to see if the drug reduces the number of asthma attacks over a year.

What this could mean

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

Active substance
TQC2731 injection (a monoclonal antibody targeting TSLP)
What this could lead to
If successful, this could provide a new treatment option to reduce asthma attacks in people with severe asthma that is not well controlled by current medications.
What could go wrong
This is a Phase 2 trial with 205 participants, so results are still early. The drug may not prove effective or safe in larger studies, and side effects are possible.

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

205 people

The number who actually took part.

Started

Sep 2022

Finished

Mar 2025

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 Age. 18-75 * 2 Documented physician-diagnosed asthma for at least 12 months before visit 1. * 3 Subjects who have received a physician-prescribed asthma controller medication with medium or high dose inhaled glucocorticosteroid (ICS) for at least 12 months before visit 1. * 4 Documented treatment with a total daily dose of either medium or high dose ICS for at least 3 months before visit 1. * 5 At least one additional maintenance asthma controller medication such as Long acting β2 receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, Long-acting muscarinic antagonists (LAMA), sodium cromoglycate, etc. is required according to standard practice of care and must be documented for at least 3 months. * 6 Morning pre-BD FEV1 \<80% predicted normal At visit 2 or visit 2a. * 7 Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months before visit 1 OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening At visit 2 or visit 2a. * 8 Documented history of at least 2 asthma exacerbation events within 12 months before visit 1. * 9 ACQ-6 score ≥1.5 at visit 1 * 10 Body weight ≥ 40 kg at visit 1. Exclusion Criteria: * 1 Pulmonary disease other than asthma. * 2 History of cancer. * 3 Current smokers or subjects with smoking history ≥10 pack-years. * 4 Hepatitis B, C, human immunodeficiency virus (HIV) or Syphilis. * 5 History of anaphylaxis following any biologic therapy. * 6 History of chronic alcohol or drug abuse within 12 months. * 7 History of a clinically significant infection. * 8 Pregnant or breastfeeding.

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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.

Severe asthma

Contacts and locations

Locations

  • GUANGZHOU FIRST PEOPLE's HOSPITAL

    Guangzhou, Guangdong, 510180, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000, China

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