Alopecia areata
Conditions
Interventions
Experimental group:Ivarmacitinib 4 mg, taken orally once daily, for a continuous treatment period of 24 weeks.
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18–65 years old (inclusive of both ends), gender not specified. 2.Clinical diagnosis of severe alopecia (based on AAS scale assessment*). 3.Within the past 2 years, you have received continuous treatment with standard doses of baricitinib (4 mg, once daily) or lutetuzumab (50 mg, once daily) for a minimum of 6 months, and your response to treatment was poor (defined as a SALT score improvement rate = 50 after treatment). 4.Willingness to receive treatment with imatinib. 5.I agree to adhere to the trial treatment protocol and visit schedule, voluntarily participate in this study, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.A history of any severe, clinically significant disease or condition that cannot be controlled, or a history of surgery, which may impact the evaluation of the safety and efficacy of the investigational drug. Examples include severe infections, active tuberculosis, severe liver disease, tumors, mental health disorders, and so on. 2.Women who are pregnant or breastfeeding, or those planning to have a child in the near future. 3.Participation in a clinical trial within the previous month prior to screening. 4.The researchers believe that there may be other factors among the study participants that could impact adherence or make them unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Week 24 SALT30 response rate is used as the primary efficacy endpoint, representing the proportion of study participants whose SALT scores improve by>=30% from baseline after treatment.The Week 24 SALT30 response rate is used as the primary efficacy endpoint, representing the proportion of study participants whose SALT scores improve by =30% from baseline after treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The response rates for SALT50, SALT80, and SALT100 represent the proportion of study participants whose SALT scores improved by >=50%, >=80%, and >=100% compared to baseline after treatment;SALT =2 points from baseline after treatment;Adverse Events, AEs; | — |
Countries
China
Contacts
Public ContactWei Shi
Xiangya Hospital, Central South University
Outcome results
None listed