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New eczema drug 611 shows promise in large chinese trial

NCT ID NCT06173284

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tested a new drug called 611 in 519 Chinese adults with moderate-to-severe atopic dermatitis (eczema). 611 is an antibody that blocks a key driver of allergic inflammation. The study compared 611 injections to a placebo over 16 weeks, measuring skin clearance and severity scores. The trial is completed, and results will show if 611 can effectively reduce eczema symptoms.

What this could mean

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

Active substance
611 (a lab-made antibody that blocks a protein involved in allergic inflammation)
What this could lead to
If successful, 611 could offer a new treatment option for Chinese adults with moderate-to-severe eczema, helping to clear skin and reduce itch.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. As a biologic, it may have side effects like injection reactions or infections. It may not work for everyone.

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

519 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 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. Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent. 2. Male or female adults ages 18 to 75 years old when signing the informed consent. 3. AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit. 4. Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at the screening and baseline visits. 5. Investigator's Global Assessment (IGA) score \>=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits. 6. Participants with \>=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits. 7. Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity \>=4. 8. Recent history (within 12 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks). 9. Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit. 10. Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose. Exclusion Criteria: 1. Presence of skin comorbidities that may interfere with study assessments 2. Presence of active endoparasitic infections; or suspected endoparasitic. 3. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC). 4. History of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix at least 1 year, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin at least 1 year. 5. Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. 6. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent infections, per investigator judgment. 7. Active TB, unless that was well documented that the participants had adequately treated. 8. Any medical condition that, in the opinion of the investigator, is serious or unstable and may affect the subject's safety and/or prevent the subject from completing the study 9. Treatment with topical drugs such as corticosteroids, topical calcineurin inhibitors, PDE inhibitors, or Janus kinase (JAK) inhibitors within 2 weeks before baseline; 10. The lab abnormalities at screening or baseline and not suitable for inclusion in the study judged by investigator; 11. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. 12. History of alcohol or drug abuse within 6 months before baseline. 13. History of hypersensitivity to 611 or their excipients. 14. Have been vaccinated with live (attenuated) vaccine within 2 months before baseline or planned during the study period; 15. Have used any investigational drug/treatment within 12 weeks before baseline; 16. Planned or anticipated major surgical procedure during the patient's participation in this study. 17. Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period. 18. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

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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

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi, 330200, China

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

  • The Fourth Affiliated Hospital Zhejiang University School of Medicine

    Jinhua, Zhejiang, 322000, China

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