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New shot could tame tough eczema in large trial

NCT ID NCT06468956

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This Phase 3 trial tests an experimental injection called SHR-1819 in 652 adults with moderate to severe atopic dermatitis (eczema). Half get the drug, half get a placebo. The main goal is to see if it improves skin rash and itch after 16 weeks. If it works, it may offer a new way to control this chronic skin condition.

What this could mean

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

Active substance
SHR-1819 injection
What this could lead to
If successful, this could provide a new treatment option to control moderate to severe atopic dermatitis, reducing skin inflammation and itch.
What could go wrong
This is still an experimental drug. Even in Phase 3, it may not prove more effective than placebo, and side effects are possible. Results may not apply to all patients.

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

652 people

The number who actually took part.

Started

Jun 2024

Finished

Aug 2026

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. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol; 2. The age was ≥18 at the time of signing the informed consent and gender is unlimited; 3. Atopic dermatitis at screening (according to the 2014 American Society of Dermatology guideline criteria, see Annex 1) and disease duration for at least 1 year before screening as judged by the investigator; 4. EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods; 5. TCS was not optimal or not tolerated by the investigator. Exclusion Criteria: 1. Pregnant or lactating women; 2. Major surgeries are planned for the duration of the study; 3. History of previous atopic corneal conjunctivitis involving the cornea; 4. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis; 5. Subjects have had or are currently clinically significant diseases or abnormalities; 6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening; 7. The drug has been used in the previous 6 months; 8. Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma); 9. Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation; 10. Any cause that the researchers believe would prevent the participants 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

  • Shanghai Fudan University HuaShan Hospital

    Shanghai, Shanghai Municipality, 200040, China

More trials for these conditions

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