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New pill could clear psoriasis skin in major trial

NCT ID NCT06842199

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests an oral drug called ICP-488 in 383 adults with moderate to severe plaque psoriasis. Participants are randomly assigned to receive either the drug or a placebo for 16 weeks. The main goal is to see if the drug can significantly clear or nearly clear the skin, as measured by doctor assessments and symptom scores.

What this could mean

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

Active substance
ICP-488 (an oral tablet)
What this could lead to
If successful, this could provide a new oral treatment option for people with moderate to severe plaque psoriasis, potentially improving skin clearance.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects are possible. It is only tested in Chinese adults, so results may not apply to other populations.

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

About 383 people

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

Started

Mar 2025

Expected to finish

Feb 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: Eligible subjects must meet all of the following criteria: 1. Subjects voluntarily participate in this study and have signed informed consent. 2. Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF. 3. History of plaque psoriasis ≥6 months at baseline. 4. Subjects need to receive systemic therapy and/or phototherapy. 5. The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores Exclusion Criteria: 1. The diagnosis was non-plaque psoriasis. 2. Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments. 3. Presence of infection or immune-related disease. 4. Subjects with a history of TB or at risk for TB. 5. Received related treatment within the time window specified in the protocol. 6. An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2/CYP3A4 inhibitor or inducer, or a plan to use concurrently medications with strong CYP1A2/CYP3A4 inhibitory or inductive effect during study participation. 7. The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol. 8. Pregnant or lactating women, or women who plan to become pregnant during study participation. 9. A history of severe drug allergies. 10. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this 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.

How to take part

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

  1. The places running it

    2 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 Hospital of Chengde Medical University

    COMPLETED

    Chengde, Hebei, 067000, China

  • Beijing Chao-Yang Hospital,Capital Medical University

    COMPLETED

    Beijing, Beijing Municipality, 100020, China

  • Beijing Friendship Hospital, Capital Medical University

    COMPLETED

    Beijing, Beijing Municipality, 100050, China

  • Beijing Tongren Hospital,CMU

    COMPLETED

    Beijing, Beijing Municipality, 100730, China

  • Chengdu Second People's Hospital

    COMPLETED

    Chengdu, Sichuan, 610017, China

  • Chongqing Traditional Chinese Medicine Hospital

    COMPLETED

    Chongqing, Chongqing Municipality, 400021, China

  • Dermatology Hospital of Jiangxi Province

    COMPLETED

    Nanchang, Jiangxi, 330000, China

  • Dermatology Hospital of Southern Medical University

    COMPLETED

    Guangzhou, Guangdong, 510091, China

  • First Affiliated Hospital of Gannan Medical University

    COMPLETED

    Ganzhou, Jiangxi, 341000, China

  • Fujian Medical University Union Hospital

    COMPLETED

    Fuzhou, Fujian, 350001, China

  • Henan Provincial People's Hospital

    COMPLETED

    Zhengzhou, Henan, 450003, China

  • Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences,peking union medical college

    COMPLETED

    Nanjing, Jiangsu, 210042, China

  • Huashan Hospital, Fudan University

    COMPLETED

    Shanghai, Shanghai Municipality, 200040, China

  • Jingzhou Central Hospital

    COMPLETED

    Jingzhou, Hubei, 434020, China

  • Liuzhou People's Hospital

    COMPLETED

    Liuzhou, Guangxi, 545006, China

  • Nanyang Central Hospital

    COMPLETED

    Nanyang, Henan, 473000, China

  • Northeast International Hospital

    COMPLETED

    Shenyang, Liaoning, 110000, China

  • Peking University Third Hospital

    COMPLETED

    Beijing, Beijing Municipality, 100191, China

  • Qilu Hospital of Shandong University

    COMPLETED

    Jinan, Shandong, 250012, China

  • Sanmenxia Central Hospital

    COMPLETED

    Sanmenxia, Henan, 472000, China

  • Shanghai Skin Disease Hospital skin Disease of tongji University

    COMPLETED

    Shanghai, Shanghai Municipality, 200443, China

  • Sichuan Provincial People's Hospital

    COMPLETED

    Chengdu, Sichuan, 610072, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    COMPLETED

    Guangzhou, Guangdong, 510120, China

  • Taiyuan Central Hospital

    COMPLETED

    Taiyuan, Shanxi, 030009, China

  • The 2nd Affiliated Hospital of Harbin Medical University

    COMPLETED

    Harbin, Heilongjiang, 150001, China

  • The Affiliated Hospital of Guizhou Medical University

    COMPLETED

    Guiyang, Guizhou, 550001, China

  • The First Affiliated Hospital Of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315000, China

  • The First Affiliated Hospital of Anhui Medical University

    COMPLETED

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Chongqing Medical University

    COMPLETED

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Fujian Medical University

    COMPLETED

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Kunming Medical University

    COMPLETED

    Kunming, Yunnan, 650032, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, 710061, China

  • The First Hospital of Jilin University

    COMPLETED

    Changchun, Jilin, 130021, China

  • The First People's Hospital of Changzhou

    COMPLETED

    Changzhou, Jiangsu, 213003, China

  • The First People's Hospital of Lianyungang

    COMPLETED

    Lianyungang, Jiangsu, 222002, China

  • The Fourth Affiliated Hospital, Zhejiang University School of Medicine

    COMPLETED

    Jinhua, Zhejiang, 322000, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    COMPLETED

    Hangzhou, Zhejiang, 310009, China

  • The Second Affiliated Hospital of Henan University of Science and technology

    COMPLETED

    Luoyang, Henan, 471000, China

  • The Second Affiliated Hospital of Wannan Medical College

    COMPLETED

    Wuhu, Anhui, 241000, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    COMPLETED

    Xi’an, Shanxi, 710114, China

  • The Second Hospital of Hebei Medical University

    COMPLETED

    Shijiazhuang, Hebei, 050000, China

  • The Second Xiangya Hospital of Central South

    COMPLETED

    Changsha, Hunan, 410011, China

  • The first Affiliated hospital of Wenzhou Medical University

    COMPLETED

    Wenzhou, Zhejiang, 325000, China

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    COMPLETED

    Tianjin, Tianjin Municipality, 300120, China

  • Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)

    COMPLETED

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital of Central South University

    COMPLETED

    Changsha, Hunan, 410008, China