A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 231
- 主要终点
- Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
研究概览
简要总结
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.
ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide.
Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.
- •Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2 and < 90 mL/min/1.73 m^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening.
排除标准
- •Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.
- •Any exclusionary medical diseases, disorders, or conditions as described in the protocol.
研究组 & 干预措施
ABBV-CLS-628 Dose A
Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
干预措施: ABBV-CLS-628 (Drug)
ABBV-CLS-628 Dose B
Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
干预措施: ABBV-CLS-628 (Drug)
ABBV-CLS-628 Dose C
Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
干预措施: ABBV-CLS-628 (Drug)
Placebo
Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
时间窗: Week 96
TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 118 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline(Week 96)
- Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)(Week 48)
- Absolute Change in eGFR From Baseline(Week 48)
- Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR(Up to Week 96)