NCT06785012已完成2 期
A Randomized, Double-blind, Multicenter, Placebo-controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-89495120 as Monotherapy in Adult Participants With Major Depressive Disorder (MDD)
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
- 105
- 试验地点
- 44
- 主要终点
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 5
研究概览
简要总结
The purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary psychiatric diagnosis of recurrent major depressive disorder, without psychotic features, based on clinical assessment using diagnostic and statistical manual of mental disorders (DSM)-5 criteria and confirmed with the mini international neuropsychiatric interview (MINI)
- •Participant had to have at least one previous major depressive disorder (MDD) episode prior to their current episode
- •Were first diagnosed with depression before the age of 55
- •Are in a current episode of depression: Episode length must be at least 2 months but not longer than 24 months
- •Have taken 0, 1, or 2 treatments for depression in your current episode
- •Body mass index (BMI) within the range 18 to 35 kilograms per square meter (kg/m^2) at screening
排除标准
- •Treatment with vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), deep brain stimulation (DBS), or ketamine/esketamine within the current or past major depressive episodes
- •Current or past DSM-5 diagnosis of bipolar disorder, psychotic disorders, borderline personality disorder, antisocial personality disorder, or current obsessive-compulsive disorder
- •Post-traumatic stress disorder within the past three years of screening
- •Dementia, any dementing disease, intellectual disability, or neurocognitive disorder
- •History of Alcohol and Substance use disorders within 6 months of screening, with the exclusion of nicotine, caffeine, and mild cannabis use disorder, according to the MINI and Clinical Assessment
- •Known allergies, hypersensitivity, or intolerance to JNJ-89495120 or its excipients
研究组 & 干预措施
Arm 2: JNJ-89495120 Dose A and Dose B
Experimental
Participants will receive JNJ-89495120 dose A in Period 1 followed by JNJ-89495120 dose B in Period 2 during the DB treatment phase of the study.
干预措施: JNJ-89495120 (Drug)
Arm 3: Placebo Group
Placebo Comparator
Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study.
干预措施: Placebo (Drug)
Arm 1: JNJ-89495120 Dose A
Experimental
Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study.
干预措施: JNJ-89495120 (Drug)
结局指标
主要结局
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 5
时间窗: Baseline up to Day 5
The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
次要结局
- Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scale Score to Day 5(Baseline up to Day 5)
- Change from Baseline in MADRS Total Score to Day 2(Baseline up to Day 2)
- Change from Baseline in Clinician Global Impression-Severity (CGI-S) Scale Score to Days 2 and 5(Baseline up to Day 2 and Day 5)
- Change from Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score to Day 5(Baseline up to Day 5)
- Number of Participants with Adverse Events (AEs)(Up to approximately 18 weeks)
- Number of Participants with Abnormalities in Vital Signs Parameters(Up to approximately 18 weeks)
- Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities(Up to approximately 18 weeks)
- Number of Participants With Abnormalities in Laboratory Parameters(Up to approximately 18 weeks)
- Number of Participants Reporting Changes in Weight/Body Mass Index (BMI)(Up to approximately 18 weeks)
- Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score(Up to approximately 18 weeks)
- Change from Baseline in Cognitive Functioning Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)(From Baseline up to 4 weeks)
- Change from Baseline in Cognitive Functioning Measured by the Digit Symbol Substitution Test (DSST)(From Baseline up to 4 weeks)
- Plasma Concentrations of JNJ-89495120(Pre-dose (0 hours), and Post-dose on Days 1, 5 and 13)
研究者
研究点 (44)
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相关资讯
J&J's M1 Antagonist PIPE-307 Misses Primary Endpoint in Phase 2 MDD Trial, Second Setback for the Molecule- The Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in major depressive disorder failed to meet its primary MADRS efficacy endpoint at Day 5 versus placebo.
- The M1 receptor antagonist was well tolerated with no new safety signals, and Johnson & Johnson is still analyzing prespecified exploratory endpoint data.
- The miss is the second Phase 2 failure for the molecule, following the VISTA trial in relapsing-remitting multiple sclerosis in 2025.
- Analysts removed the asset from financial models, shifting Contineum's valuation focus to its wholly owned LPA1 antagonist PIPE-791 for idiopathic pulmonary fibrosis.11 days agoContineum's JNJ-5120/PIPE-307 Misses Primary Endpoint in Phase 2 MOONLIGHT-1 Depression Trial- The Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 did not meet its primary efficacy endpoint in adults with major depressive disorder, Contineum Therapeutics reported.
- The trial assessed improvement from baseline in MADRS total score at Day 5 versus placebo; the M1 receptor inhibitor was well-tolerated with no new safety signals.
- Johnson & Johnson, which develops the drug under a global license agreement, is analyzing prespecified exploratory endpoints to assess clinical relevance and next steps.
- Contineum separately affirmed its Phase 2 PROPEL-IPF trial of PIPE-791, now with more than 55 sites across eight countries, and a cash runway through mid-2029.last monthContineum Therapeutics Advances PIPE-791 Phase 2 Trial for Idiopathic Pulmonary Fibrosis with Differentiated LPA1 Receptor Targeting- Contineum Therapeutics has initiated patient dosing in PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for idiopathic pulmonary fibrosis, targeting 324 patients over 26 weeks with a primary endpoint of forced vital capacity change.
- PIPE-791 demonstrates potential differentiation from Bristol Myers Squibb's competing LPA1 antagonist through achieving approximately 90% receptor occupancy at 1 mg daily dosing and showing no hypotension signal to date.
- The company maintains financial runway through mid-2029 following a $93 million public offering, while also advancing PIPE-307 in partnership with Johnson & Johnson for major depressive disorder treatment.
- Topline data from an exploratory PIPE-791 Phase 1b chronic pain trial is expected in Q2 2026, potentially supporting quality-of-life benefits in pulmonary fibrosis populations.6 months ago