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.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;
✕. 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;

Percentage of subjects with Alopecia Severity Score Tool (SALT) score < or = 20%

Timeframe: Week 24

NCT IDNCT06562894

SponsorCSPC Ouyi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-31

Clinical Trials Information Group officer

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;
✕. 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;