Phase 2 Vitiligo Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older (men and women) diagnosed with non-segmental vitiligo (a specific type of vitiligo that does not follow nerve patterns on the body)
• People whose vitiligo affects between 4% and 60% of their total body surface area (not counting the palms, soles of the feet, or tops of the feet)
• People whose vitiligo affects at least 0.5% of the face, where the face is defined as the area from the forehead to the jawline and from the corners of the mouth to just in front of the ears (not including the scalp, ears, neck, lip surfaces, but including the nose and eyelids)
• People whose vitiligo scores meet specific measurement thresholds on standard scoring tools used by doctors (F-VASI of 0.5 or higher and T-VASI of 3 or higher)
• People with either active or stable vitiligo
• Women who are able to become pregnant and have been using an effective form of contraception (such as the pill, implant, IUD, condoms, or tubal ligation) for more than one month before joining, and who have a negative pregnancy test at the start of the study
• Women who cannot become pregnant because they have had their uterus or ovaries removed, have medically confirmed ovarian failure, or have been confirmed as post-menopausal (no menstrual periods for at least 12 consecutive months)
• People who are enrolled in a social security system (confirm with trial site, as this may apply to the country where the trial is being conducted)
• People who have read, understood, and signed a consent form agreeing to take part

Who may not be able to join:

• Women who are pregnant or breastfeeding, or women who are able to become pregnant but are not using contraception, or who plan to become pregnant during the study
• People with segmental vitiligo or mixed vitiligo (types other than non-segmental)
• People for whom light therapy using narrow-band UVB is not medically suitable
• People currently using topical or systemic medicines that suppress the immune system, including steroids
• People who have used certain skin treatments for vitiligo (such as corticosteroids, vitamin D creams, or calcineurin inhibitors) or topical or oral JAK inhibitors within 2 weeks before the study start date
• People who have ever used permanent depigmentation treatments for vitiligo or other pigmentation conditions (such as monobenzone or phenol)
• People who have ever taken any systemic (whole-body) JAK inhibitor medicine for any condition
• People who have ever received certain powerful immune system-suppressing medicines (such as alefacept, alemtuzumab, cyclophosphamide, chlorambucil) or total lymphoid irradiation
• People who have previously had surgical treatment for vitiligo (such as MKTP or similar procedures)
• People who have received certain B-cell-depleting medicines (such as rituximab) or leukocyte apheresis within 6 months before the first dose
• People who have received certain other immune-modifying biological medicines or immunosuppressants within 12 weeks before the first dose (including IL-12/23 inhibitors such as ustekinumab, or integrin inhibitors such as vedolizumab)
• People who have received light-based therapies (such as narrow-band UVB, PUVA, or other phototherapy) within 8 weeks before the study start date
• People who have received TNF inhibitors (such as infliximab, adalimumab, golimumab) or interferon therapy within 8 weeks before the study start date
• People who have taken systemic immune-suppressing medicines (such as cyclosporine, tacrolimus, azathioprine, methotrexate, systemic steroids, mycophenolate, or similar medicines), sulfasalazine, or injected/oral steroids within 8 weeks before the study start date
• People who have had contact with certain live vaccines, or who live with someone who has recently received a live attenuated vaccine, within 6 weeks before the first dose or during the study
• People taking certain medicines known to interfere with how the study drug is processed in the body (specific CYP3A inducers or substrates), or herbal medicines that may affect drug metabolism, within 4 weeks of the first dose
• People taking herbal medicines with unknown effects or known benefits for vitiligo within 1 week before the study start date
• People with skin conditions that cause sensitivity to light, or who are taking medicines that increase sensitivity to light
• People whose vitiligo-affected areas have more than 33% white or grey hair within the lesions (either on the face or across the total body)
• People with a personal history of skin cancer
• People with a personal history of any cancer, except those who have been fully treated for certain non-spreading skin cancers (basal cell carcinoma, squamous cell carcinoma) or cervical carcinoma in situ
• People with an active infection or other active systemic or inflammatory disease
• People with active or latent tuberculosis (TB), or a positive TB screening test result (confirm with trial site regarding retesting procedures)
• Vulnerable individuals, including pregnant or breastfeeding women, people under 18, adults under legal guardianship, people who are detained, or people with certain psychiatric conditions
• People currently participating in another clinical trial involving a medicine that could interfere with this study's results
• People with recent or active thoughts of suicide or self-harm, or a history of serious suicidal behaviour in the past 5 years, as assessed using a standard screening tool
• People who currently have other conditions that cause changes in skin pigmentation (such as Vogt-Koyanagi-Harada disease, pityriasis alba, chemical-induced pigment loss, or certain inherited pigmentation disorders), though the presence of halo nevi is permitted
• People who currently have other inflammatory skin conditions (such as psoriasis, lupus, or leprosy) that could interfere with assessing the vitiligo
• People who have had a superficial skin infection within 2 weeks before the first dose (though rescreening may be possible after the infection clears)
• People who have had a serious infection requiring hospitalisation or intravenous treatment within 6 months before the first dose
• People with an active infection requiring antibiotic or antiviral treatment within 4 weeks before the first dose
• People with a history of widespread herpes zoster or herpes simplex, or more than one episode of localised herpes zoster
• People who test positive for hepatitis B surface antigen, or who have certain hepatitis B antibody results indicating active infection, or who test positive for both hepatitis C antibody and hepatitis C RNA
• People with a known immune deficiency disorder, a positive HIV test at screening, or a close family member with a hereditary immune deficiency
• People with serious, uncontrolled conditions affecting the kidneys, liver, blood, digestive system, metabolism, hormones, lungs, heart, or nervous system, or any other severe medical condition that may increase the risk of participating
• People with a known severe allergic reaction to any JAK inhibitor or to any ingredient in the study medicine
• People with significant hearing loss that has worsened over the past 5 years, sudden hearing loss, or certain ear conditions (such as Meniere's disease, labyrinthitis, or cholesteatoma)
• People with a history of lymphoma, leukaemia, EBV-related lymphoproliferative disorder, or signs of current lymph system disease
• People whose chest imaging shows abnormal findings that may increase the risk of participating (such as active TB, serious infection, heart muscle disease, or cancer)
• People with Long QT Syndrome, a family history of Long QT Syndrome, or a history of a heart rhythm problem called Torsades de Pointes
• People who have had major surgery or significant injury within 1 month before the first dose, or who have surgery planned during the study period
• People with severe liver impairment

Important: Always verify eligibility with the trial site directly before applying.