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

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05702268
• Collaborator: (none)
• Enrollment: 75
• Locations: 22
• Arms: 3
• Anticipated Duration (Months): 10.1
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Atopic Dermatitis	Drug: ICP-332; Drug: ICP-332 Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Feb 25, 2023
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-dose 40 mg ICP-332 tablet 3 tablets, once a day	Drug: ICP-332; Tablet, 40 mg
Experimental: Low-dose 40 mg ICP-332 2 tablets + 1 placebo tablet once daily	Drug: ICP-332; Tablet, 40 mg; Drug: ICP-332 Placebo; Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.
Placebo Comparator: Blank control Placebo 3 tablets once daily	Drug: ICP-332 Placebo; Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.

Outcome Measures

Primary Outcome Measures

1. Adverse events (AEs) [Up to 24 weeks]

2. Systolic and Diastolic Blood Pressure [Up to 24 weeks]

3. Pulse Rate [Up to 24 weeks]

4. Electrocardiogram (ECG) QT Interval [Up to 24 weeks]

5. Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0 [Up to 24 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female subjects aged ≥18 years and ≤75 years.

2. 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).

3. During screening and baseline, were defined as meeting the moderate and severe AD criteria as assessed by the researchers.

4. Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) , or other medically unrecommended topical therapy.

5. 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.

6. 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.

7. Subjects must voluntarily sign and date informed consent prior to the commencement of any screening or study specific procedures.

8. Subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

9. Fertile women (WOCBP) must 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.

Exclusion Criteria:

1. Pregnant female subjects and nursing female subjects.

2. Subjects who had an active skin disease or skin infection that required systemic treatment or would interfere with the proper assessment of AD.

3. 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.

4. Active HBV, HCV or HIV, syphilis infection.

5. 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.

6. Except for atopic dermatitis, he has any clinically significant disease history or other clinically significant systemic diseases.

7. Received the specified treatment plan within the specified time frame.

8. 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.

9. Those with a history of drug or alcohol abuse in the 6 months prior to baseline visit (as determined by the investigator).

10. 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.

11. The investigator considers for any reason that the subject is not suitable for participation in the study to receive ICP-332.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Hospital	Beijing	Beijing	China	100006
2	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China	100050
3	Peking University Third Hospital	Beijing	Beijing	China	100191
4	Second Hospital of the Army Medical University	Chongqing	Chongqing	China	400037
5	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350004
6	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong	China	510091
7	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510260
8	The Affiliated Hospital of Chengde Medical College	Chengde	Hebei	China	067020
9	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050023
10	Nanyang First People's Hospital	Nanyang	Henan	China	473004
11	Wuhan University People's Hospital	Wuhan	Hubei	China	430060
12	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu	China	210031
13	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China	110002
14	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200025
15	Shanghai Dermatology Hospital	Shanghai	Shanghai	China	220443
16	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai	China
17	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030001
18	Suining Central Hospital	Suining	Sichuan	China	629099
19	Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine	Tianjin	Tianjin	China	300120
20	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310003
21	Hangzhou Third People's Hospital	Hangzhou	Zhejiang	China	310009
22	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China	325015

Sponsors and Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05702268
• Other Study ID Numbers: ICP-CL-00602
• First Posted: Jan 27, 2023
• Last Update Posted: Jan 27, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Jan 27, 2023