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

NCT06562894 | Not Yet Recruiting Phase 2

• 1 other identifier: SYHX1902-006
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Severe Alopecia Areata

Keywords

plaque psoriasis

Outcome Measures

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

  Week 24

Study Arms (4)

SYHX1901 dose 1

EXPERIMENTAL

Drug: SYHX1901

SYHX1901 dose 2

EXPERIMENTAL

Drug: SYHX1901

SYHX1901 dose 3

EXPERIMENTAL

Drug: SYHX1901

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SYHX1901 DRUG

Administered orally, once daily (QD)

SYHX1901 dose 1; SYHX1901 dose 2; SYHX1901 dose 3

Placebo DRUG

Administered orally, once daily (QD)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Have received a live vaccine within 60 days before the first dose of the study drug or plan to receive a live vaccine between the middle of the study and 60 days after the end of the study;
• History of severe herpes zoster or sever herpes simplex infection;
• HBV-related tests are abnormal at screening;
• HCV antibody positive and HCV RNA positive at screening;
• Human immunodeficiency virus antibody positive or treponema pallidum antibody positive;
• Any known or suspected condition of congenital or acquired immunodeficiency;
• Previous or current active tuberculosis infection or latent tuberculosis infection (LTBI) deemed by the investigator/specialist to require treatment;

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: May 26, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): November 17, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share