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New drug ICP-332 aims to soothe stubborn hives when antihistamines fail

NCT ID NCT07378527

Disease control Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental pill called ICP-332 in 344 adults with moderate to severe chronic spontaneous urticaria (hives) that antihistamines can't control. Participants will take the drug or a placebo for 12 or 24 weeks. The main goal is to see if the drug reduces itching and hives better than placebo.

What this could mean

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

Active substance
ICP-332 tablets
What this could lead to
If successful, this could provide a new oral treatment option for people with chronic hives that don't respond well to standard antihistamines.
What could go wrong
This is an early-to-mid stage trial (Phase 2/3) with 344 participants. The drug may not prove more effective than placebo, and side effects are still being studied.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 344 people

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

Started

Feb 2026

Expected to finish

Sep 2028

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: * 1\. Men and women aged 18 to 75 years. * 2\. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines. * 3\. CSU duration for ≥ 6 months prior to randomization. * 4\. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form. Exclusion Criteria: * 1\. Having the other medical conditions related to CSU or other skin diseases/conditions. * 2\. Potential medical conditions or issues. * 3\. Pregnant female subjects or lactating female subjects. * 4\. The investigator determines that the subject is unsuitable for participating in this study for any reason.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

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

Chronic spontaneous urticaria (CSU)

How to take part

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

  1. The places running it

    30 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 Hangzhou First People's Hospital, School of Medicine, Westlake University

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • Affiliated Hospital of Jiangsu University

    NOT_YET_RECRUITING

    Zhenjiang, Jiangsu, 210031, China

  • Beijing Tongren Hospital, Capital Medical University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Bengbu Medical University First Affiliated Hospital

    NOT_YET_RECRUITING

    Bengbu, Anhui, 233004, China

  • Chengdu Second People's Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610017, China

  • Chongqing Traditional Chinese Medicine Hospital

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, 400021, China

  • Dermatology Hospital of Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510091, China

  • First Affiliated Hospital of Fujian Medical University

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350005, China

  • First Hospital of Shanxi Medical University

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030001, China

  • Hangzhou Third People's Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Henan Provincial People's Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450003, China

  • Jinan Central Hospital

    NOT_YET_RECRUITING

    Jinan, Shandong, 250013, China

  • Jingzhou Central Hospital

    NOT_YET_RECRUITING

    Jingzhou, Hubei, 434020, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Shandong Provincial Hospital for Skin Disease, Shandong First Medical University

    NOT_YET_RECRUITING

    Jinan, Shandong, 250022, China

  • Shanghai Skin Disease Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200443, China

  • Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • Shiyan Taihe Hospital

    NOT_YET_RECRUITING

    Shiyan, Hubei, 442000, China

  • Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610072, China

  • Suzhou Municipal Hospital

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, 215002, China

  • The First Affiliated Hospital of Chongqing Medical University

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Kunming Medical University

    NOT_YET_RECRUITING

    Kunming, Yunnan, 650032, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The First Hospital of Jilin University

    NOT_YET_RECRUITING

    Changchun, Jilin, 130021, China

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

    NOT_YET_RECRUITING

    Luoyang, Henan, China

  • The Second Affiliated Hospital of Wannan Medical College

    NOT_YET_RECRUITING

    Wuhu, Anhui, 241000, China

  • The Second Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300131, China

  • Wuxi No. 2 People's Hospital

    NOT_YET_RECRUITING

    Wuxi, Jiangsu, 214001, China

  • Xiangya hospital central south university

    NOT_YET_RECRUITING

    Changsha, Hunan, 410008, China

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