ICP-332 treatment for non-segmental vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, parallel-group, adaptive Phase II/III multi-center trial with distinct Phase 2 and Phase 3 portions. Eligible participants have non-segmental vitiligo for at least three months with total body VASI between 5 and 50, facial VASI ≥0.5, at least 5% body surface area affected, and meet age and weight criteria for the relevant phase. Participants are randomized to receive oral ICP-332 tablets or matching placebo and are followed for efficacy and safety outcomes related to repigmentation and tolerability. Sites for the trial are located in China at affiliated hospitals in Wuhu and at Peking University Third Hospital in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male or female subjects ≥12 years of age and ≤75 years of age, adolescent subjects must weigh ≥40 kg (Phase III portion).
2. Eligible subjects must meet all of the following criteria at screening and baseline:

   1. The clinical diagnosis was non-segmental vitiligo for at least 3 months.
   2. Involvement of BSA≥5%.
   3. Facial involvement BSA≥0.5%.
   4. F-VASI≥0.5 and T-VASI between 5 and 50.
   5. Active or stable non-segmental vitiligo was present at both screening and baseline visits.
3. Women of childbearing potential (WOCBP) and Men must agree to contraception.
4. Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent.

Exclusion Criteria:

1. Any of the following vitiligo related medical conditions and other skin diseases/conditions.

   a) Subjects had other types of vitiligo (including but not limited to segmental vitiligo and mixed vitiligo) that did not meet the criteria for active or stable vitiligo described in Inclusion criteria 2.
2. History of any clinically major diseases, with the exception of vitiligo.
3. Pregnant or breastfeeding females.
4. The investigator considers that the subject is not suitable for participation in this study for any reason.

Where it's running

• Chongqing Traditional Chinese Medicine Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting
• Huashan Hospital Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Hangzhou Third People's Hospital
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Not yet recruiting
• The Second Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Not yet recruiting

Study contacts

• Study coordinator: Flora Xiang, Doctor
• Email: flora_xiang@vip.163.com
• Phone: 021-52887775

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Test of ACT-777991 in adults with non-segmental vitiligo

  This study tests whether ACT-777991 can help restore skin color in adults with non-segmental vitiligo, compared to placebo.

  Recruiting Phase 2 Idorsia Pharmaceuticals Ltd. · Los Angeles, California and 4 other locations · NCT07667569

• Different doses of GIA632 for adults with non-segmental vitiligo

  This trial tests whether different doses of GIA632 can safely help restore skin pigment in adults with non-segmental vitiligo.

  Recruiting at 85 sites Phase 2 Novartis · Birmingham, Alabama and 84 other locations · NCT07431177

• SHR0302 tablets with or without SHR0302 base gel for non-segmental vitiligo

  This trial will test whether SHR0302 tablets, alone or together with an SHR0302 base gel, help adults with non-segmental vitiligo and are safe to use.

  Recruiting Phase 2 Jiangsu HengRui Medicine Co., Ltd. · Jinan, Shandong · NCT07251595

• Phase 2 EI-001 for non-segmental vitiligo

  This trial will test whether the antibody drug EI-001 can help adults (18–65) with non‑segmental vitiligo regain skin pigment more than a placebo.

  Recruiting at 7 sites Phase 2 Elixiron Immunotherapeutics (Hong Kong) Ltd. · Huntington Beach, California and 7 other locations · NCT07223229

• VC005 tablets for people with non-segmental vitiligo

  This trial will test VC005 tablets to see if they safely help adults aged 18–70 with non-segmental vitiligo regain skin pigment.

  Recruiting Phase 2 Jiangsu vcare pharmaceutical technology co., LTD · Beijing, Beijng · NCT07172347

• Roflumilast 0.3% foam for children with non-segmental vitiligo

  This trial will try a roflumilast 0.3% topical foam to see if it helps children and teens (ages 2–17) with non-segmental vitiligo affecting small areas including the face.

  Recruiting Phase 2 Derm Texas, PLLC · Dallas, Texas · NCT07105254

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.