NCT06340360进行中（未招募）2 期
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
- 试验地点
- 27
- 主要终点
- Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
研究概览
简要总结
This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata.
The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, an optional 16-week treatment extension period, and a 24-week follow-up period. The maximum study duration is approximately 81 weeks for all participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who are at least 18 years and ≤60 years for males (≤70 years of age for females) old at the time of informed consent
- •Diagnosis of Alopecia Areata (AA) severity at screening and baseline:
- •severe to very severe AA (≥ 50% scalp involvement) as measured using the SALT score
- •Documented history over 6 months with no spontaneous improvement prior to baseline
- •Current episode of severe to very severe AA of less than 8 years
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and baseline.
- •While on investigational product and for at least 30 days after taking the last dose of investigational product (IP), WOCBP who engage in activity in which conception is possible must use approved highly effective contraceptive method(s). For male patient with partner that is WOCBP in which conception is possible, male patient must agree to use approved highly effective contraceptive method(s).
- •Able to complete patient questionnaires
- •Able and willing to comply with requested study visits and procedures
- •Able and willing to provide written informed consent
- •Able to communicate, read and/or understand the local language
排除标准
- •Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
- •Patient has primarily "diffuse" type AA (characterized by diffuse hair shedding).
- •Presence of another form of alopecia.
- •Prior use of any of the following treatments:
- •aldesleukin
- •investigational IL-2 analog
- •oral Janus kinase (JAK) inhibitor for any indication, including, but not limited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, and ruxolitinib, whether marketed or investigational
- •systemic immune-modulating biologic therapy (including, but not limited to, dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, rituximab, ocrelizumab, ofatumumab, belimumab, daxdilimab, etc.) whether marketed or investigational
- •History of cancer or lymphoproliferative disease within 5 years prior to Day
- •Note: Patients with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma with no evidence of metastatic disease for 3 years and/or localized carcinoma in situ of the cervix with no evidence of recurrence within the 3 years prior to Day 1 are not to be excluded.
- •Current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening.
- •Other skin conditions that would interfere with study assessments of AA
结局指标
主要结局
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
时间窗: Baseline and Week 36
The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
次要结局
- Percent change from baseline in SALT score(Baseline and Weeks 12, 16, 20, 24, 28, and 32)
- Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90%(Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36)
- Proportion of patients achieving an absolute SALT score ≤ 10/20/30/50(Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36)
- Percent change from baseline in SALT score at Weeks 12, 16, 20, 24, 28 and 32
- Proportion of patients achieving improvement in SALT (≥50%, ≥75%, and ≥90%) relative to their baseline score (SALT50, SALT75 and SALT90) at Weeks 12, 16, 20, 24, 28, 32, and 36
- Proportion of patients achieving an absolute SALT score ≤10, ≤20, ≤30, ≤50 relative to their baseline score at Weeks 12, 16, 20, 24, 28, 32, and 36
研究者
研究点 (27)
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