Study to Evaluate Safety and Efficacy of SYHX1901 Tablets in Severe Alopecia Areata Patients (NCT06562894) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study to Evaluate Safety and Efficacy of SYHX1901 Tablets in Severe Alopecia Areata Patients
156 participantsStarted 2025-05-26
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of severe alopecia areata.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects fully understand and voluntarily participate in this study and sign informed consent;
. Subjects aged ≥18 to ≤ 65 years;
. Clinical diagnosis of alopecia areata,with at least 50% scalp hair loss，as defined by a SALT score ≥50 at screening and baseline visit;
. The current episode of hair loss was less than 10 years ago, and there was no evidence of spontaneous hair regrowth within 6 months before screening (the overall duration of alopecia areata more than 10 years could be included);
. Subjects must be volunteer and be able to understand informed consent Forms;
. Subjects and their partners should voluntarily take contraceptive measures considered effective by the investigator during the study period and for at least 28 days after the study;
Exclusion criteria
. Participants who have received hair implants;
. Alopecia caused by other reasons;
. Other active scalp or systemic diseases that may cause severe alopecia or affect the clinical evaluation of alopecia areata;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects with Alopecia Severity Score Tool (SALT) score < or = 20%
. Participants who have a clinically significant (as assessed by the investigator) abnormality in TSH or free T4 at screening and who were deemed by the investigator to be ineligible for the study;
. Participants who wore stick-on wigs and refused to stop wearing them during the study;
. Bacterial, fungal, or viral infection requiring hospitalization/intravenous treatment within 4 weeks before the first dose of study drug or requiring oral treatment within 2 weeks before the first dose of study drug;
. Have any chronic infection that requires systemic anti-infective therapy;