Study to Evaluate Safety and Efficacy of SYHX1901 Tablets in Severe Alopecia Areata Patients

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCSPC Ouyi Pharmaceutical Co., Ltd.

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

Qualifiers

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

Treatments tested in this trial

  • SYHX1901
  • Placebo

Treatment groups

156 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Collaborator