BridgeMD
New treatment option for Non Segmental Vitiligo
Official title ICP-332 in Subjects With Non-segmental Vitiligo
ClinicalTrials.gov ID: NCT07047612
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 non segmental vitiligo.
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
- This a phase II/III randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part.
- 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 12 to 75
You may be able to join if
- Male or female people aged ≥18 years and ≤75 years (Phase II portion). Male or female people ≥12 years of age and ≤75 years of age, adolescent people...
- Eligible people must meet all of the following criteria at screening and baseline:
- The clinical diagnosis was non-segmental vitiligo for at least 3 months.
- Involvement of BSA≥5%.
- Facial involvement BSA≥0.5%.
You likely can't join if
- Any of the following vitiligo related medical conditions and other skin diseases/conditions. a) people had other types of vitiligo (including but not...
- History of any clinically major diseases, with the exception of vitiligo.
- Pregnant or breastfeeding females.
- The investigator considers that the subject is not suitable for participation in this study for any reason.
See the full eligibility criteria
- Male or female people aged ≥18 years and ≤75 years (Phase II portion). Male or female people ≥12 years of age and ≤75 years of age, adolescent people must weigh ≥40 kg (Phase III portion).
- Eligible people must meet all of the following criteria at screening and baseline:
- The clinical diagnosis was non-segmental vitiligo for at least 3 months.
- Involvement of BSA≥5%.
- Facial involvement BSA≥0.5%.
- F-VASI≥0.5 and T-VASI between 5 and 50.
- Active or stable non-segmental vitiligo was present at both screening and baseline visits.
- Women of childbearing potential (WOCBP) and Men must agree to contraception.
- Before beginning any screening or study specific procedures, people must voluntarily sign informed consent.
- Any of the following vitiligo related medical conditions and other skin diseases/conditions. a) people had other types of vitiligo (including but not limited to segmental vitiligo and mixed vitiligo) that did not meet...
- History of any clinically major diseases, with the exception of vitiligo.
- Pregnant or breastfeeding females.
- The investigator considers that the subject is not suitable for participation in this study for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhu, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Luoyang, Henan, China
- Nanyang, Henan, China
- Weihui, Henan, China
- Zhengzhou, Henan, China
- Jingzhou, Hubei, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hengyang, Hunan, China
- Lianyungang, Jiangsu, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
+ 11 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, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhu, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China and 25 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.