NCT04034134已完成2 期
A Phase Ⅱ Study to Evaluate the Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Severe Alopecia Areata.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Effective rate
研究概览
简要总结
This was an open-label, Multi-center, randomized phase Ⅱ study. Patients with severe Alopecia Areata were randomized to receive 50mg bid, 150mg qd or 200 mg qd of oral Jaktinib Hydrochloride Tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years age or older ,male or female；
- •Alopecia areata diagnosed clinically；
- •Patients with alopecia accounting for 50% or more of the total scalp area and stable for at least 6 months or more；
- •Patients can complete treatment for at least six months；
- •Requirements for pregnant or lactating female and male and female of childbearing age；Female patients must be satisfied：Menopause (defined as no menstruation for at least one year);Or have been surgically sterilized；Or have fertility, but must satisfy：Pregnancy tests conducted within 7 days before randomization must be negative；And agree to use appropriate contraceptive methods throughout the trial period, including at least one barrier method；And no breastfeeding；Male patients must agree to use appropriate contraceptive measures throughout the trial, including at least one barrier method；
- •Patients are voluntarily enrolled in the Study and can be treated and visited according to the requirements of the protocol after signing the Informed Consent Form；
排除标准
- •Alopecia caused by syphilitic alopecia, thyroid disease, trichotilomania, head moss, connective tissue disease, infection, zinc deficiency and iron deficiency;
- •Patients with acute diffuse alopecia areata (ADTAFS)
- •Patients with active tuberculosis
- •The following diseases were combined within 6 months before randomization:thyroid diseases ，liver diseases, malnutrition, heart diseases, nervous system diseases, gastrointestinal disorders, tumors and psychiatric diseases
- •HIV positive, active hepatitis B virus positive (HBsAg or HBeAg positive) and HCV-RNA positive at screening；
- •Other patients with abnormal history or clinical manifestations that may affect participants participation in the study or may confuse the results of the study；
- •Within two weeks before randomization，Patients who received glucocorticoid topical therapy, anthracene ointment, minoxidil, SADBE/DPCP contact immunotherapy, photochemotherapy or cryotherapy；
- •Before randomization，oral or injected any medicines to treat hair loss (including the glucocorticoids was detected in injection, systemic corticosteroids, antihistamines, stephania drugs, glycyrrhizin, glycine, methionine compound tablet, compound glycyrrhizin glucoside) and other liquorice extract, ring spore element, anti TNF antibody, IFN - gamma, IL - 2 antibodies, for alopecia areata therapy of traditional Chinese medicine and other JAK inhibitor) and washout period less than seven half-life of patients;
- •Participants in a clinical trial of any drug or medical device within 4 weeks prior to randomization.
研究组 & 干预措施
Jaktinib Hydrochloride Tablets 50mg bid
Experimental
Oral tablet for 24 weeks
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Jaktinib Hydrochloride Tablets 150mg qd
Experimental
Oral tablet for 24 weeks
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Jaktinib Hydrochloride Tablets 200mg qd
Experimental
Oral tablet for 24 weeks
干预措施: Jaktinib Hydrochloride Tablets (Drug)
结局指标
主要结局
Effective rate
时间窗: From randomization of the first subject until the last subject complete 6 months treatment
Effective rate = (cure + obvious effect + effective)/total cases \*100%;
次要结局
- SALT score change(From randomization of the first subject until the last subject complete 6 months treatment)
- Quality of Life (AASIS)(From randomization of the first subject until the last subject complete 6 months treatment)
研究者
研究点 (2)
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