New eczema pill shows promise in early trial

NCT ID NCT07465120

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests an experimental drug called CMS-D001 in 160 adults with moderate to severe atopic dermatitis (eczema) that hasn't responded well to creams. Participants will take one of three doses of the drug or a placebo daily for several weeks. The main goal is to see if the drug can reduce eczema severity by at least 75%.

What this could mean

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

Active substance
CMS-D001 (an experimental oral drug)
What this could lead to
If successful, this could lead to a new daily pill option for people with moderate to severe eczema that is not well controlled by creams.
What could go wrong
This is an early Phase 2 study with only 160 people, so results may not hold up in larger trials. The drug is new and side effects are not yet fully known.

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

About 160 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

May 2027

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 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: * Aged 18-75 years, willing to sign the ICF * Clinical diagnosis of AD (Hanifin \& Rajka criteria) for ≥1 year * At screening and baseline, EASI score ≥ 16 points, IGA ≥ 3, BSA ≥ 10%, Itch NRS ≥ 4 * Documented history of inadequate response to topical corticosteroids (TCS) or -topical calcineurin inhibitors (TCI). * Subject has applied a topical emollient (moisturizer) daily for at least 7 days prior to the Baseline Visit. Exclusion Criteria: * Other active skin conditions that may interfere with AD assessment. * History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose. * History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose. * Active infection or acute illness within 7 days prior to the first dose. * Chronic or recurrent infectious diseases at screening or baseline that may increase safety risks. * Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol. * History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation. * History of malignant tumour within 5 years before screening. * Previous or current autoimmune diseases. * Positive results of confirmatory test for hepatitis B, hepatitis C, human * immunodeficiency virus (HIV) or syphilis. * Allergic to any component of the investigational drug.

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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.

How to take part

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

  1. The places running it

    28 sites. 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

  • Affiliated Central Hospital of Shenyang Medical College

    Shenyang, Liaoning, China

  • Affiliated Hospital of Binzhou Medical University

    Binzhou, Shandong, China

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, China

  • Affiliated Hospital of North China University of Science and Technology

    Tangshan, Hebei, China

  • Beijing Huairou Hospital

    Beijing, Beijing Municipality, China

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, China

  • First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, China

  • Hainan Provincial Fifth People's Hospital

    Haikou, Hainan, China

  • Hangzhou No.1 People's Hospital

    Hangzhou, Zhejiang, China

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang, China

  • Hebei Medical University Second Hospital

    Shijiazhuang, Hebei, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, China

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, China

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai Municipality, China

  • Shenyang Hospital of Integrated Traditional Chinese and Western Medicine

    Shenyang, Liaoning, China

  • Shiyan People's Hospital

    Shiyan, Hubei, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, China

  • Southern Medical University Dermatology Hospital

    Guangzhou, Guangdong, China

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China

  • Wuhan No.1 Hospital

    Wuhan, Hubei, China

  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, China

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