Non-segmental vitiligo
Conditions
Interventions
Control group:VC005 Tablet Simulant (2 tablets)
Experimental group1:VC005 Tablet Simulant (2 tablets)
Experimental group2:VC005 tablet 25mg (25mg × 1 tablet) VC005 tablet placebo (1 tablet)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the study, be able to follow the relevant procedures of the trial, voluntarily participate in clinical trials and sign informed consent form (ICF); 2. When signing the ICF, IC was 18-75 years old (including bounds), regardless of gender. 3. The clinical diagnosis is non-segmental vitiligo, and F-VASI >= 0.3, T-VASI >= 5 during screening period and baseline visits, and the affected BSA ranged from 4% to 60% (including bounds). Note: The face is defined as the entire area from the forehead to the original hairline, from the cheek to the mandible line in the vertical direction, and from the corners of the mouth to the ear screen in the horizontal direction. The facial area does not include the surface area of the scalp, ears, neck or lips, but includes the nose and eyelids. 4. Agree to stop all drugs and procedures for the treatment of vitiligo (including the screening period until the completion of safe follow-up) throughout the study period. 5. Female and male subjects with fertility (WOCBP) and male subjects agreed to use reliable contraceptive methods during the study and at least 30 days after the last administration, such as abstinence, oral/injection/subcutaneous implanted contraceptives, intrauterine devices, barrier methods (condoms, vaginal diaphragms and cervical caps, etc.). Female subjects with fertility must have negative results in the baseline blood pregnancy test before screening and first medication. All subjects should agree that sperm/egg donation should not be carried out within 30 days from the first drug to the last drug. Note: WOCBP is defined as a woman who has not reached the postmenopausal state after menarche (continuous amenorrhea for at least 12 months, no other clear reason except menopause), and no surgery (i.e. bilateral osopyectomy and/or bilateral salpingectomy and/or hysterectomy) or other reasons determined by the researcher (such as Mueller tube Hypoplasia) leads to permanent infertility.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or subjects with pregnancy or breastfeeding plans during the study. 2. All the hair in the facial vitiligo area is white. 3. Other forms of vitiligo (such as segmental type or undetermined type [limited type]); or other skin pigmentation disorders (such as rash, white spot disease, leprosy, post-inflammatory hypopigmentation, progressive spotted hypomelanosis, anemia mole, melasma, chemical white skin disease and ringworm); or congenital hypopigmentation disease ( Including albinism, Waddenberg's syndrome, Ito hypopigmentation, pigment incontinence, hereditary symmetrical anomaly, colored dry skin and apigmented mole), or vitiligo-like graft-versus-host disease (GVHD). 4. During screening or baseline visits, there are active/inflammatory skin diseases or skin disease manifestations (such as hard spot disease, lupus discos, leprosy, psoriasis) that may interfere with the research and evaluation. 5. There were clinically significant (determined by researchers) thyroid-stimulating hormone (TSH) and free thyroxine (FT4) or free triiodothyrogenine (FT3) abnormalities, and the subjects believed that the subjects were not suitable to participate in this study. 6. Have received any of the following treatments during the eluation period specified before D1 (baseline): ? Within 8 weeks: have received any form of phototherapy. ? Within 4 weeks: any systemic vitiligo treatment (such as immunomodulatory drugs: methotrexate, mycophenolate, corticosteroids, cyclosporine); drugs that increase the skin's sensitivity to ultraviolet light (UV)/visible light or affect skin pigmentation: tetracycline drugs, methoxy osteolipids or other vitiligo treatment (Antioxidant/vitamin/herbal medicine/traditional Chinese medicine); use dihydroxyacetone (usually found in sun-free skin tanning agent); inoculate live vaccine or live attenuated vaccine. ? Within 2 weeks: topical drugs used in the vitiligo area, such as topical corticosteroids (TCS), topical calcium-regulated neurophosphatase inhibitors (TCI), JAK inhibitors, phosphodiesterase type 4 (PDE-4) inhibitors, vitamin A acid drugs or vitamin D3 derivatives; used for the treatment of vitiligo Traditional Chinese medicine for treatment (including traditional Chinese herbal medicine and traditional Chinese medicine). ? Within 12 weeks: oral JAK inhibitors; immunomodulatory biological preparations (within 5 drug half-life or 12 weeks, whichever is the longest). 7. I have been treated with decolorizer in the past. 8. Spontaneous and significant pigment regeneration occurs within 6 months before screening (such as pigment regeneration without any treatment, and the researcher determined that the number is significant). 9. Any of the following laboratory test indicators meet the criteria during screening: - **Blood Routine**: White blood cell count (WBC) 2×upper limit of normal (ULN), total bilirubin (TBIL) >=1.5×ULN; - **Renal Function**: Serum creatinine >1.5×ULN or estimated glomerular filtration rate (eGFR) 2, prothrombin time (PT) or acti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in facial vitiligo area score index (F-VASI).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving T-VASI 75;Percent change from baseline in systemic vitiligo involved area (T-BSA).;Change from baseline in vitiligo-specific quality of life scale (VitiQoL).;Proportion of subjects achieving T-VASI 90;Proportion of subjects with a 50% improvement in total vitiligo area score index (T-VASI) = from baseline (T-VASI 50).;Proportion of subjects who achieve F-VASI 90;F-VASI % change from baseline;Percent change from baseline in T-VASI;Proportion of subjects achieving F-VASI 75;Percent change from baseline in facial vitiligo involved area (F-BSA).;Proportion of subjects with an improvement of =50% (F-VASI 50) from baseline in F-VASI; | — |
Countries
China
Contacts
Public ContactZhou Cheng, Zhang Jianzhong
Peking University People's Hospital
Outcome results
None listed