Clinical trial for Atopic Dermatitis
Official title ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT06775860
What this study is testing
What is ICP-332 Tablets?
ICP-332 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female people between 18 and 75 years of age.
- Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
- Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
- people must meet the following criteria for disease activity:
- Eczema Area and Severity Index (EASI) score ≥ 16 ;
You likely can't join if
- Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis...
- Pregnant or breastfeeding females.
- History of any clinically major diseases, with the exception of atopic dermatitis.
- Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.
See the full eligibility criteria
- Male or female people between 18 and 75 years of age.
- Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
- Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
- people must meet the following criteria for disease activity:
- Eczema Area and Severity Index (EASI) score ≥ 16 ;
- (Body Surface Area )BSA affected by AD ≥ 10% ;
- (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;
- Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
- Women of childbearing potential (WOCBP) and Men must agree 5\. Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory...
- Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- Pregnant or breastfeeding females.
- History of any clinically major diseases, with the exception of atopic dermatitis.
- Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Wuhu, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Shaoguan, Guangdong, China
- Shenzhen, Guangdong, China
- Liuzhou, Guangxi, China
- Chengde, Hebei, China
- Handan, Hebei, China
- Shijiazhuang, Hebei, China
- Luoyang, Henan, China
- Sanmenxia, Henan, China
- Zhengzhou, Henan, China
- Jingzhou, Hubei, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hohhot, Inner Mongolia, China
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Wuhu, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.