About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Participants who have shaved their heads;
Trial design
Parallel
Treatments tested in this trial
SYHX1901
DrugAdministered orally, once daily (QD)
Placebo
DrugAdministered orally, once daily (QD)
Treatment groups
Trial outcomes
Primary outcomes
Percentage of subjects with Alopecia Severity Score Tool (SALT) score < or = 20%
Percentage of subjects achieving a SALT score \< or = 20% at week 24
Locations
Sponsors and contacts
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CSPC Ouyi Pharmaceutical Co., Ltd.
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: