A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD- 2)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 169
- 主要终点
- Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
研究概览
简要总结
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.
The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for major depressive disorder
- •Are on stable standard of care medication for major depressive disorder
- •Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
- •self-inject study intervention
- •store and use the provided blinded study intervention, as directed
- •maintain electronic and paper study diaries, as applicable, and
- •complete the required questionnaires
排除标准
- •Have a lifetime history or current diagnosis of the following:
- •schizophrenia spectrum or other psychotic disorder
- •bipolar disorder
- •borderline personality disorder, or
- •any eating disorder
- •Have type 1 diabetes mellitus, or a history of:
- •ketoacidosis, or
- •hyperosmolar state or coma.
- •Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- •Are actively suicidal or deemed a significant risk for suicide
- •Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening
研究组 & 干预措施
Brenipatide Dose 2
Brenipatide administered SC + SoC.
干预措施: Brenipatide (Drug)
Brenipatide Dose 3
Brenipatide administered SC + SoC.
干预措施: Brenipatide (Drug)
Placebo
Placebo administered SC + SoC.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
时间窗: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months
次要结局
- Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥ 25.0 kg/m^2(Baseline, up to at least 6 months)
- Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Baseline, up to at least 6 months)
- Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score(Baseline, up to at least 6 months)
- Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form(Baseline, up to at least 6 months)
- Change from Baseline in Patient Global Impression of Severity (PGI-S)(Baseline, up to at least 6 months)
- Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score(Baseline, up to at least 6 months)
- Change from Baseline in Patient Rated Symptom and Disease Severity(Baseline, up to at least 6 months)
- Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score(Baseline, up to at least 6 months)
- Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m² and on an Atypical Antipsychotic(Baseline, up to at least 6 months)
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline, up to at least 6 months)
- Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA(Baseline up to at least 6 months)