Phase 1 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:

Part 1 – Healthy volunteers:

• You are able to understand and agree to the study by signing a consent form
• You are between 18 and 45 years old (male or female)
• You weigh between 50 and 120 kg and have a BMI between 17.0 and 28.0

Part 2 – Vitiligo group:

• You are a male between 18 and 65 years old
• You have been diagnosed with non-segmental vitiligo (a specific type of vitiligo) for at least 3 months but less than 2 years
• Your vitiligo affects between 3% and 50% of your body, with at least some involvement on your face, and you have at least one currently active patch (confirm with trial site for exact measurements)
• You agree to use reliable contraception and avoid donating sperm for 6 months after your last dose

Part 2 – Severe alopecia areata group:

• You are a male between 18 and 60 years old
• You have severe alopecia areata (significant hair loss affecting at least 50% of the scalp), with no natural improvement in the past 6 months, and your severe hair loss has lasted at least 6 months but less than 4 years
• You agree to use reliable contraception and avoid donating sperm for 6 months after your last dose

Who may not be able to join:

• You have a known allergy to any ingredient in the study drug (IBI3013)
• You are unable to tolerate injections given under the skin
• You have received a live vaccine in the past 30 days, or expect to need one during the study or within 3 months after finishing
• You donated blood or lost 400 mL or more of blood in the 3 months before the study screening
• You have a history of shingles (herpes zoster) or severe or recurring herpes simplex virus infections
• You have a known history of active tuberculosis, symptoms that could suggest tuberculosis, or a positive TB blood test that makes you unsuitable (confirm with trial site)
• You have significant abnormalities in your vital signs, blood tests, heart trace (ECG), or other medical checks that the study doctor considers a concern
• You have recently taken certain treatments or taken part in another drug study within a timeframe set by the study (confirm with trial site for exact timeframes)
• You have a history of drug misuse or dependence, or tested positive for drugs during screening within the past 12 months
• You are pregnant or currently breastfeeding
• You have an existing or previous medical condition that the study doctor feels makes participation unsuitable
• Vitiligo and alopecia areata groups: You have another condition that could affect how the study drug works or how safely your results can be measured
• Vitiligo group: You have a different or mixed type of vitiligo, or another skin condition that could interfere with the study assessments
• Alopecia areata group: You have a specific pattern of hair loss called diffuse alopecia areata or ophiasis, or another type of hair loss that could affect study results
• Alopecia areata group: You previously tried oral JAK inhibitor medications and they did not work well for you
• Alopecia areata group: You have had a heart attack, unstable heart disease, stroke, or severe heart failure in the past 12 weeks; or you have a history of or high risk of blood clots in the veins; or you have a serious mental health condition that the study doctor feels makes participation unsuitable

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