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:

• People who are willing and able to follow all trial procedures and requirements, including using digital tools and apps, in the opinion of the trial doctor.
• People who have signed a written consent form and any required privacy documents before any trial procedures begin.
• People who have been clinically diagnosed with nonsegmental vitiligo, with specific severity scores for facial and total body vitiligo falling within a defined range at the screening visit and at Day 1 (confirm exact score thresholds with trial site).
• People aged 18 to 75 years old at the time of signing the consent form.
• People who meet the trial's birth control requirements — this includes people who are confirmed to be past menopause by lab testing, or people who agree to use a highly effective form of contraception throughout the trial if there is any possibility of pregnancy; people assigned male sex at birth are also required to use effective contraception (confirm specific requirements with the trial site, particularly for those in the EU/EEA or UK where additional assessments may apply).
• People in the EU/EEA or UK for whom the trial doctor has no reason to believe they would be placed at increased risk by joining, in line with specific European and UK safety guidelines for a class of medicines called JAK inhibitors (confirm with trial site).

Who may not be able to join:

• People who have segmental vitiligo (including mixed vitiligo), or any other condition — present from birth or developed later — that causes loss of skin colour and could affect the diagnosis or assessment of nonsegmental vitiligo.
• People who have more than 50% white hairs within the vitiligo-affected skin on their face, or more than 50% white hairs across their body including the face.
• People who need immune-suppressing or immune-modifying medicines (other than common anti-inflammatory medicines like ibuprofen) during the trial for a condition affecting the immune system, such as inflammatory bowel disease.
• People who have used any form of light therapy for their skin — including UV-B treatment, UV-A with a sensitising medicine, laser therapy, or tanning booths — within 8 weeks before Day 1.
• People who have another skin condition that, in the trial doctor's opinion, would interfere with trial assessments.
• People who have ever used bleaching or depigmenting treatments on their skin, such as monobenzone or phenol.
• People who have ever had surgery to treat vitiligo.
• People who have a recent or ongoing unexplained hearing loss.
• People who have ever had active tuberculosis (TB), currently show symptoms of active TB (such as ongoing fever, persistent cough, night sweats, or unexplained weight loss), or have test results suggesting latent (inactive) TB infection without documented completion of or willingness to start appropriate preventive treatment (confirm specific TB testing and treatment requirements with trial site, as additional specialist approval may be required in the EU/EEA and the UK).
• People who have had a chest x-ray or scan in the 6 months before screening — or who require one as part of screening — that shows signs of current or past active TB (a chest x-ray is required for all participants unless a normal one was done within the previous 6 months).
• People who have an active herpes virus infection (including cold sores or shingles) at the time of screening or Day 1.
• People who have a history of a severe herpes infection, including herpes that spread through the body, herpes affecting the brain or eyes, or shingles that has occurred in more than one area of the body or has come back twice within two years.
• People who have hepatitis C virus (HCV) confirmed by two types of blood tests showing active infection.
• People who have hepatitis B virus (HBV) detected in their blood through various blood tests, depending on which specific markers are found (confirm exact criteria with trial site).
• People who test positive for HIV.
• People who have had a fever or active infection in the 7 days before Day 1.
• People who have had a serious or severe infection in the 30 days before Day 1.
• People who have needed hospitalisation or intravenous antibiotic, antiviral, or antifungal treatment for an infection within 8 weeks before Day 1, or oral antibiotic treatment within 30 days before Day 1.
• People who have a history of long-term or repeated bacterial infections, such as recurring kidney or bladder infections, chronic lung infections, bone infections, or persistent skin infections or fungal infections (excluding a superficial fungal nail infection).
• People who have an infected joint replacement, unless the implant was removed or replaced at least 60 days before Day 1.
• People who have had a serious opportunistic infection — the type that typically occurs when the immune system is weakened — such as certain types of pneumonia or fungal infections.
• People who had a bacterial infection within 60 days before Day 1 that was not treated.
• People who have a significant or unstable medical condition affecting the heart, kidneys, liver, blood, digestive system, hormones, lungs, nerves, nutrition, eyes, or immune system, or abnormal results on vital signs, physical examination, lab tests, or heart electrical recordings (ECG) that the trial doctor believes would put them at undue risk or affect the trial results. This includes, but is not limited to:
  • People with a known or suspected condition that weakens the immune system, including removal of the spleen.
  • People with a new or unstable autoimmune disease such as thyroid disease, lupus, Sjögren's syndrome, myasthenia gravis, or rheumatoid arthritis.
  • People who have had major surgery within 60 days before Day 1, or who have major surgery planned during the trial.
  • People with unstable, poorly controlled, or severe high blood pressure confirmed at screening.
  • People with a history of severe heart failure (Class III or IV as defined by medical classification guidelines).
  • People with a history of cancer or lymphatic system disease, with the exception of certain successfully treated skin cancers or localised cervical cancer in specific circumstances (confirm with trial site, as additional assessments apply in the EU/EEA and UK).
  • People with asthma, chronic obstructive pulmonary disease, or other lung conditions who have ever been placed on a breathing machine, currently need steroid tablets for their lungs, have needed more than one course of steroid tablets for their lungs in the 6 months before Day 1, or have been hospitalised for their lungs within 3 months before Day 1.
  • People with certain heart-related conditions in the past 6 months, including newly diagnosed or symptomatic irregular heartbeat, blood clots in the lungs, deep vein blood clots, or a non-urgent heart hospitalisation (such as for a pacemaker); or any history of stroke, heart attack, coronary artery stenting, or heart bypass surgery (though exceptions may apply in some circumstances — confirm with trial site).
  • People with ECG results showing heart electrical abnormalities that the trial doctor considers to pose an unacceptable risk.
  • People with any lifetime history of suicide attempts, suicidal behaviour, or specific types of suicidal thoughts as assessed by a standard rating scale, or those the trial doctor considers to be at risk of suicide.
  • People with a history of clinically significant drug or alcohol misuse within 12 months before Day 1.
• People whose blood test results at screening fall outside specified safe ranges for liver enzymes, bilirubin (a liver marker), haemoglobin (a measure of red blood cells), white blood cells, neutrophils (a type of immune cell), lymphocytes (another immune cell type), platelets, thyroid hormones, kidney function, or a muscle enzyme called CPK (confirm exact values with trial site).
• People with other significant abnormal lab results that the trial doctor believes would make participation unsafe.
• People who are unable to tolerate or have a needle inserted for blood draws.
• People with a history of a severe allergic reaction to any medicine, such as anaphylaxis.
• People with a known or suspected allergy to the trial medicine (zasocitinib) or any of its ingredients.
• People who are pregnant, planning to become pregnant, undergoing IVF, planning to donate eggs or sperm, or who are currently breastfeeding.
• People who have donated more than 500 mL of blood or plasma within 30 days of screening, or who plan to donate blood during the trial.
• People who are being held involuntarily in a medical or other institution by legal or government order.
• People who work at the trial site, or are an immediate family member of someone who does and is involved in running the trial, or who could be in a position where consent may not be fully free.
• People with a history of a condition called rhabdomyolysis (a serious breakdown of muscle tissue).

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