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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SYHX1901

    Drug

    Administered orally, once daily (QD)

  • Placebo

    Drug

    Administered orally, once daily (QD)

Treatment groups

156 Participants
are divided into 4 treatment groups
Group A: SYHX1901 dose 1Experimental treatment 1 intervention
Group B: SYHX1901 dose 2Experimental treatment 1 intervention
Group C: SYHX1901 dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Percentage of subjects achieving a SALT score \< or = 20% at week 24

Time frame
Week 24

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: