A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 396
- 试验地点
- 111
- 主要终点
- Mean percent change in EASI from baseline at Week 16
研究概览
简要总结
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 15-35 days for screening, an Induction Period of 16 weeks, a Maintenance Period from Week 16-Week 52, and a Posttreatment Follow-Up Period for an additional year up to approximately Week 104 for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (from at least 18 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer prior to screening.
- •AD disease severity at screening and randomization:
- •EASI of 16 or higher
- •IGA of 3 or 4
- •BSA of 10% or more
- •Documented history, within 6 months prior to the screening visit, of either inadequate response or inadvisability of topical treatments.
- •Able to complete patient questionnaires.
- •Able and willing to comply with requested study visits and procedures.
- •Able and willing to provide written informed consent.
排除标准
- •Prior use of systemic immune modulating therapies for AD (i.e., JAK inhibitors or biologics)
- •Other skin conditions that would interfere with assessment of AD
- •Treatment with a live (attenuated) immunization within 12 weeks prior to screening.
- •Men and women (of reproductive potential) unwilling to use highly effective birth control and women who are pregnant or breastfeeding.
- •Any malignancies or history of malignancies within 5 years prior to randomization (except for basal cell or squamous epithelial carcinomas of the skin that have been successfully treated with no evidence of metastatic disease for 3 years or cervical carcinoma in situ that has been successfully treated, with no evidence of recurrence within the 3 years prior to randomization).
- •Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening.
- •Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
- •Concurrent participation in any other investigational clinical study.
研究组 & 干预措施
Arm C2
Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
Arm C
Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period
干预措施: Rezpegaldesleukin (Drug)
Arm A
Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period
干预措施: Rezpegaldesleukin (Drug)
Arm A2
Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period
干预措施: Placebo (Drug)
Arm A1
Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
Arm C2
Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period
干预措施: Placebo (Drug)
Arm D
Placebo every 2 weeks during the induction period
干预措施: Placebo (Drug)
Arm D1
Placebo every 4 weeks during the maintenance period
干预措施: Placebo (Drug)
Escape Therapy (open-label)
Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
Arm B2
Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
Arm B
Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period
干预措施: Placebo (Drug)
Arm B2
Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period
干预措施: Placebo (Drug)
Arm A2
Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
Arm B1
Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
Arm B
Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period
干预措施: Rezpegaldesleukin (Drug)
Arm C1
Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
结局指标
主要结局
Mean percent change in EASI from baseline at Week 16
Mean percent change in EASI from baseline at Week 16
次要结局
- Proportion of patients from baseline at Week 16 achieving • vIGA AD of 0 or 1 and at least a 2-point reduction. • EASI-75 • EASI 90 • EASI-50 • ≥ 4-point improvement from baseline in Itch NRS in the subset of patients with ≥ 4-point Itch NRS at baseline. • SCORAD-75 • SCORAD-50
- Mean change from baseline over the period between Week 0 and Week 104 in • EASI • SCORAD • BSA involvement
- Mean percent change from baseline over the period between Week 0 and Week 104 in • EASI • SCORAD • BSA involvement
- In addition, all of the above efficacy assessments will be further evaluated at other time points during induction therapy, maintenance therapy, and follow-up - Rezpegaldesleukin plasma concentrations at various time points assessed throughout the study. - Incidence of • Serious adverse events (SAEs) • Treatment-emergent adverse events (TEAEs)