CTRI/2024/10/075478招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,092
- 试验地点
- 21
- 主要终点
- To evaluate the efficacy of 2doses of BMS-986278, 60 mg and 120 mg BID, compared with PBO, in demonstrating improvement in absolute change in FVC from baseline at
研究概览
简要总结
Condition/Disease: PPF
Study Hypothesis :To demonstrate the efficacy and safety of BMS-986278 60 and 120 mg BID, compared with PBO, in improving lung function by testing the absolute change in FVC (mL) from
baseline at Week 52 in participants with PPF.
Study Duration: Approximately 3 years.
Study Investigational Medicinal Product Duration: Approximately 3 years.
Health Measurement/Observation:Improvement in lung function.
Study Visit Frequency: After Week 4, visits will be every 6 weeks up to Week 52, and every 12weeks from Week 52 to EOT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed Written Informed Consent, Type of Participant and Target Disease Characteristics-a) A clinical Diagnosis of ILD and greater than or equal too 10% parenchymal fibrosis within the whole lung on screening HRCT,and features consistent with progressive ILD within 24 months prior to screening, defined as any of the following: (1)Decline in relative pp FVC of greater than or equal too 10%, OR(2)Decline in relative pp FVC of greater than or equal too 5% to less than 10% and an increased extent of fibrosis on prescreening thoracic CT compared with prior imaging, OR (3)Decline in relative pp FVC of greater than or equal too 5% to less than 10% and symptoms associated with progression of ILD, OR (4)Symptoms associated with progression of ILD and an increased extent of fibrosis on prescreening thoracic CT compared with prior imaging b)pp FVC greater than or equal too 40%.
- •c)Forced expiratory volume in 1 second (FEV1)/FVC greater than or equal too 0.7 d)Single-breath, hemoglobin-corrected, pp DLCO greater than or equal too 25%.
- •e)If on pirfenidone or nintedanib, participants must have been receiving a stable dose for at least 90 days prior to screening.
- •f)If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within28 days prior to screening.
- •g)Participants with sarcoidosis and other CTD-ILDs will be allowed in Cohort
- •However, participants with rheumatoid arthritis ILD are allowed in Cohort 1 and Cohort
- •h)Investigator has considered all available pulmonary fibrosis treatment options prior to obtaining informed consent.
- •Age of Participant Participant must be greater than or equal to 21years of age at the time of signing the ICF.
排除标准
- •Medical Conditions a)Diagnosis of IPF confirmed by UIP pattern.
- •b)Emphysema Greater than or equal to 50% on HRCT assessed by a central reader, or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT c)Acute exacerbation of pulmonary fibrosis within 4 weeks prior to or during screening.
- •d)Clinically significant (in the opinion of the investigator)non-parenchymal lung disease (eg,asthma, chronic obstructive pulmonary disease, cavitary, or pleural diseases)at screening e)Participants who have: 1) Current malignancy; or 2) A previous malignancy within the past 5years prior to screening are excluded, except for those with a documented history of cured non metastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
- •Participants who have a biopsy that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory ,or other diagnostic evaluations, are also excluded.
- •f)Clinically significant respiratory tract infection (in the opinion of the investigator) (eg, active tuberculosis, infectious pneumonia) within 4 weeks prior to screening or during screening.
- •Additionally, in the case of prior SARS-CoV-2 infection, symptoms must have completely resolved and based on investigator assessment in consultation with the Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
- •g)History of stroke or transient ischemic attack within 3months prior to screening.
- •h)Exhibit symptoms of heart failure at rest.
- •i)History of lung reduction surgery or lung transplant.
- •Note:being on transplantation list is allowed.
- •j)Participant has known pulmonary arterial hypertension (PAH) that requires multi-drug therapy.
- •Note: Single drug therapy is permitted provided the participant is on a stable dose for 3 months prior to Day
- •k)Cigarette smoking (including e-cigarettes) within 3 months before Day
- •l)History of persistent or active post-micturition/defecation and anamnestic known syncope.
- •m)History of persistent or active postural orthostatic tachycardia syndrome.
- •n)Symptomatic bradycardia or second-or third-degree heart block.
- •o)Symptomatic valvular heart disease including mitral stenosis, aortic stenosis, bicuspid aortic valve.
- •p)Aortic dissection requiring surgery or intervention Other Exclusion Criteria a)Prisoners or participants who are involuntarily incarcerated.
- •(Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant.
- •Strict conditions apply and Sponsor approval is required.).
- •b)Inability to comply with restrictions as listed in Section 6.3: Lifestyle Restrictions.
- •c)Participation in another interventional clinical trial concurrent with this study.
- •d)Any gastrointestinal surgery or condition that in the opinion of the investigator would impact the absorption of IMP.
- •e)Inability to tolerate PO medication.
- •g)Recent (within 6 months of IMP administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Diagnostic Criteria for Drug and Alcohol Abuse.
- •i)Adults who are subject to a legal protection measure or who are unable to express their consent(eg, under court protection, persons not affiliated with a social security system, or protected adults.
结局指标
主要结局
To evaluate the efficacy of 2doses of BMS-986278, 60 mg and 120 mg BID, compared with PBO, in demonstrating improvement in absolute change in FVC from baseline at
时间窗: Baseline to Week 52
Week 52 in participants with PPF
时间窗: Baseline to Week 52
次要结局
- To evaluate the effect of BMS-98627860 and 120 mgBID, compared with PBO ,on disease(progression from baseline through EOT)
研究者
Shilpi Sinha
Bristol Myers Squibb India Pvt. Ltd
研究点 (21)
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