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Can a new antibody calm stubborn eczema when steroids fall short?

NCT ID NCT06554847

Disease control Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether an experimental antibody called 611, given as a shot alongside a topical corticosteroid, can improve moderate-to-severe atopic dermatitis (eczema) better than the steroid alone. Adults aged 18 to 75 with a history of inadequate response to topical treatments may join. Researchers measure skin clearance and itch reduction at week 16.

What this could mean

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

Active substance
611, an experimental antibody that blocks a key immune signal, combined with a topical corticosteroid
What this could lead to
If it works, 611 could offer a new treatment option for people with moderate-to-severe atopic dermatitis who do not get enough relief from topical steroids alone.
What could go wrong
This is a phase 3 trial, but success is not guaranteed. The drug may not outperform placebo, and side effects from blocking the immune signal 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 3

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

Participants

417 people

The number who actually took part.

Started

Sep 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: * Male or female adults ages 18 to 75 years old when signing the informed consent. * AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit. * Moderate to Severe Atopic Dermatitis. * Recent history of inadequate response to treatment with topical medications. Exclusion Criteria: * Participation in a prior 611 clinical study. * Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months. * Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study. * Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study. * Evidence of active acute or chronic hepatitis. * History of malignancy within 5 years before the screening visit or currently. * Pregnant or breastfeeding women, or women planning to become pregnant. * Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

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

Dermatitis, atopic Eczema, atopic

Contacts and locations

Locations

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 31003, China

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai Municipality, 200050, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010, China

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