临床试验/NCT06967805

NCT06967805招募中2 期

A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Mediar Therapeutics94 个研究点分布在 4 个国家目标入组 164 人开始时间: 2025年5月5日最近更新: 2026年8月10日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 164
试验地点: 94
主要终点: To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

详细描述

Participants with IPF who meet the study's inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to receive MTX-463 or a matching placebo by intravenous (IV) infusion. Concomitant use of one of the approved IPF therapies, pifenidone, nintedanib, or nerandomilast, is permitted, and it is expected that about half the study population will be on one of those medications. Participants randomized to the MTX-463 arm of the study will receive an IV infusion every 4 weeks, beginning at Day 0 and ending at Week 20. The End of Treatment Visit will occur at Week 24, 4 weeks after the final infusion; and a final Safety Follow-Up Visit will occur at Week 28, 8 weeks after the final infusion. Assessments of FVC will occur at Screening, Baseline, and at all subsequent treatment visits up to and including Week 24. L-PF assessments will be performed at Baseline and Week 24. Participants will have blood drawn for safety assessment and to assess WISP1 levels at Baseline and every 4 weeks throughout the study. Blood will be drawn for serum PK analyses relative to the first and last doses of MTX-463.

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: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participants with IPF of any gender ≥ 40 years of age at time of signing the informed consent.
•Able to understand the study and provide signed, written informed consent.
•Able to read and understand the language of the informed consent and other study-related materials.
•Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening.
•If a participant is on treatment with pirfenidone, nintedanib, or nerandomilast, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study. Use of any of these 3 agents in combination with each other is not permitted.
•If a participant was on treatment with pirfenidone, nintedanib, or nerandomilast, and the agent has been discontinued, this must have occurred ≥ 30 days prior to Screening. At Screening, there must also be no plan to start either of these medications for the duration of the study. Participants newly diagnosed with IPF who, in the judgment of the treating physician, are considered in need of treatment with nintedanib, pirfenidone, or nerandomilast should not defer standard of care treatment and should be excluded from the study.
•FVC of ≥ 45 percent predicted (pp) at screening.
•DLCO of ≥ 25pp at screening.
•Willing and able to complete all protocol required study visits and procedures.
•Female participants of childbearing potential must have a negative serum pregnancy test at Screening.
•Participants with reproductive potential must agree to use and follow medically approved highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer.
•Male participants with female partners of childbearing potential must use condoms during the treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer.

排除标准

•Acute exacerbation of IPF within 6 months of Screening or during the Screening Period.
•Forced expiratory volume in 1 second (FEV1)/FVC ratio of <0.7 at Screening.
•Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted.
•Expected to receive a lung transplant within the study duration.
•Current active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening.
•Planned surgery within the study duration.
•Clinically significant pulmonary hypertension.
•Use of immunosuppressive therapy (excluding corticosteroids). If previously on such agents, they should have been discontinued for at least 5 half-lives or 90 days, whichever is longer, prior to Screening.
•Use of systemic corticosteroids (prednisone or equivalent) at a dose > 10 mg once daily within 30 days of Screening.
•Currently smoking or vaping.
•Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening.
•Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
•Currently pregnant, breast feeding, or planning to conceive for the length of the study.
•History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening.
•Any clinically significant disease or laboratory abnormality detected at Screening that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety.
•Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× upper limit of normal (ULN) at Screening.
•Presence of interstitial lung disease due to any cause other than IPF, clinically significant cardiovascular disease, or any other concurrent active medical condition determined by the Investigator to interfere with the participant's ability to complete the trial.
•Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody therapeutic.
•Any prior use of MTX-463 or other therapy targeting WISP
•Any other concurrent experimental agent or an active part of any other clinical study, unless they have stopped taking the investigational product at least 5 half-lives or 30 days before Screening, whichever is longer.

研究组 & 干预措施

MTX-463

Experimental

MTX-463

干预措施: MTX-463 (Biological)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Other)

结局指标

主要结局

To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)

时间窗: 24 Weeks

Change from Baseline to Week 24 in Forced Vital Capacity (FVC)

次要结局

To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of serious treatment emergent adverse events(28 Weeks)
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent abnormalities on clinical laboratory tests(28 Weeks)
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment discontinuations(28 Weeks)
To collect sparse pharmacokinetics (PK) of MTX-463 in participants with IPF(24 Weeks)
To assess the effect of MTX-463 on the change from Baseline in the percent predicted FVC (FVCpp)(24 Weeks)
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment related adverse events(28 Weeks)
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent adverse events(28 Weeks)
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of severe treatment emergent adverse events(28 Weeks)
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of abnormal findings on physical exam(28 Weeks)
To assess the effect of MTX-463 on the change from Baseline in the percent predicted FCV (FVCpp)(24 Weeks)

研究者

发起方

Mediar Therapeutics

申办方类型

Industry

责任方

Sponsor

研究点 (94)

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