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Moderate to Severe Atopic DermatitisPhase 2NCT05702268

Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing ICP-332 in people with Moderate to Severe Atopic Dermatitis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 28 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigator, the subject, and the sponsor's project team will remain blind throughout the study. Subjects will be randomly assigned to one of the three treatment groups at a ratio of 1:1:1 to be given the drug once a day for 4 weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Moderate to Severe Atopic Dermatitis
What is being tested?
ICP-332
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
28 sitesChina
Study dates
18 Mar 2023to 30 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged ≥18 years and ≤75 years.
  • A clinical diagnosis of atopic dermatitis or eczema was made at least 1 year prior to D1, and atopic dermatitis was identified at screening visit (according to Williams criteria).
  • During screening and baseline, were defined as meeting the moderate and severe AD criteria as assessed by the researchers.
  • Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) , or other medically unrecommended topical therapy.
  • Able and willing to use an additive free mild emollient twice a day for at least 7 days prior to baseline and for the duration of the study.
  • The serum pregnancy test of all female subjects at screening visit was negative, and the urine pregnancy test of all fertile female subjects at baseline visit was negative before first dosing.
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  • Subjects must voluntarily sign and date informed consent prior to the commencement of any screening or study specific procedures.
  • Subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • Fertile women (WOCBP) menstruation must occur during the screening period and consent to use a supplementary screen contraceptive method in combination with a highly effective contraceptive method during the study period and for 90 days after the last use of the study drug .Male subjects must be willing not to donate sperm during this period.

Who cannot join

  • Pregnant female subjects and nursing female subjects.
  • Subjects who had an active skin disease or skin infection that required systemic treatment or would interfere with the proper assessment of AD.
  • Current or previous infection history, including a history of herpes; Known history of invasive infection; Chronic recurrent infection and/or active invasive infection. Known immunodeficiency syndrome; Subjects with tuberculosis; Non skin related active infection.
  • Active HBV, HCV or HIV, syphilis infection.
  • Potential medical diseases or problems, including but not limited to the following: clinically relevant or significant ECG abnormalities; History of moderate to severe congestive heart failure, recent cerebrovascular accident, myocardial infarction or coronary stent implantation, or uncontrolled hypertension; Have received organ transplantation; A history of gastrointestinal perforation, diverticulitis, or a significant increased risk of gastrointestinal perforation according to the investigator's judgment; Diseases that may interfere with drug absorption; Subjects suffering from any malignant tumor before screening.
  • Except for atopic dermatitis, he has any clinically significant disease history or other clinically significant systemic diseases.
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  • Received the specified treatment plan within the specified time frame.
  • The time from the last use of powerful CYP3A inhibitor or inducer to the first trial medication is less than 5 clearance half-life, or it is planned to take powerful CYP3A inhibitor or inducer at the same time during this study.
  • Those with a history of drug or alcohol abuse in the 6 months prior to baseline visit (as determined by the investigator).
  • During the screening period before the first administration of the study drug (baseline visit), the abnormal laboratory values met at least one of the specified standards.
  • The investigator considers for any reason that the subject is not suitable for participation in the study to receive ICP-332.

Trial locations and contacts

28 sites in 1 country.

Pengcheng Lei contact

+86 18501252185

pengcheng.lei@innocarepharma.com

28 sites in 1 country

China28 sites, 28 recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100006

    Zhonghong Xie

    Not yet recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Linfeng Li

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Chunlei Zhang

    Recruiting

  • Changzhou First People's Hospital

    Changzhou, Jiangsu, 213004

    Ruzhi Zhang

    Recruiting

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei, 067020

    Xinsuo Duan

    Recruiting

  • Second Hospital of the Army Medical University

    Chongqing, Chongqing Municipality, 400037

    Rupeng Wang

    Not yet recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350004

    Chao Ji

    Recruiting

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510091

    Yunsheng Liang

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Wenlin Yang

    Recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Hong Fang

    Recruiting

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang, 310009

    Aie Xu

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 314408

    Xiaohua Tao

    Not yet recruiting

  • Jiaxing First Hospital

    Jiaxing, Zhejiang, 314001

    Wenhao Yin

    Recruiting

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650106

    Danqi Deng

    Not yet recruiting

  • Nanyang First People's Hospital

    Nanyang, Henan, 473004

    Rixin Chen

    Recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Jie Zheng

    Recruiting

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai Municipality, 220443

    Yangfeng Ding

    Recruiting

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

    Jinhua Xu, +86 13818978539, xjhlcsy@163.com

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110002

    Li Zhang

    Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050023

    Guoqiang Zhang

    Recruiting

  • Shiyan City People's Hospital

    Shiyan, Hubei, 442099

    Zudong Meng

    Recruiting

  • Suining Central Hospital

    Suining, Sichuan, 629099

    Chunshui Yu

    Recruiting

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Wenli Feng

    Not yet recruiting

  • Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300120

    Litao Zhang

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

    Zhiming Li

    Not yet recruiting

  • Wuhan University People's Hospital

    Wuhan, Hubei, 430060

    Tiechi Lei

    Recruiting

  • Wuxi Second People's Hospital

    Wuxi, Jiangsu, 214001

    Hui Sun

    Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 210031

    Yumei Li

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Moderate-to-severe Atopic Dermatitis

The investigator, the subject, and the sponsor's project team will remain blind throughout the study. Subjects will be randomly assigned to one of the three treatment groups at a ratio of 1:1:1 to be given the drug once a day for 4 weeks.

Being tested
ICP-332, ICP-332 Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-332Drug

    Tablet, 40 mg

  • ICP-332 PlaceboDrug

    Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.

Study groups in NCT05702268
Study groupRoleWhat they receive
High-doseExperimental40 mg ICP-332 tablet 3 tablets, once a day
Receives: Drug: ICP-332
Low-doseExperimental40 mg ICP-332 2 tablets + 1 placebo tablet once daily
Receives: Drug: ICP-332; Drug: ICP-332 Placebo
Blank controlPlacebo comparatorPlacebo 3 tablets once daily
Receives: Drug: ICP-332 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

    Measured: Up to 24 weeks

  2. Systolic and Diastolic Blood Pressure

    Measured: Up to 24 weeks

  3. Pulse Rate

    Measured: Up to 24 weeks

  4. Electrocardiogram (ECG) QT Interval

    Measured: Up to 24 weeks

  5. Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0

    Measured: Up to 24 weeks

Secondary outcomes (1)

  1. Percentage change of EASI score from baseline in week 4

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start18 Mar 2023
  3. Primary completion30 Jul 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05702268
Sponsor's protocol ID
ICP-CL-00602
Status last verified
May 2023
First submitted
10 Jan 2023
Last updated
22 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu J, Zhang L, Liang Y, Ji C, Xu A, Li Z, Li L, Lei T, Zhang C, Chen R, Tao X, Zhang R, Fang H, Zheng J, Yang W, Zhang G, Duan X, Ding Y, Yin W, Zhou W, Fan D, Du Y. Safety and Efficacy of ICP-332 for Moderate to Severe Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2026 Mar 1;162(3):227-235. doi: 10.1001/jamadermatol.2025.5295.

    PubMed 41533373

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ICP-332 in people with Moderate to Severe Atopic Dermatitis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pengcheng Lei (+86 18501252185, pengcheng.lei@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) (time frame: Up to 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05702268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.

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