Pulmonary Fibrosis Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis
| Verified date | October 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.
| Status | Completed |
| Enrollment | 399 |
| Est. completion date | September 22, 2023 |
| Est. primary completion date | August 4, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | Inclusion Criteria: For the idiopathic pulmonary fibrosis (IPF) Cohort - Diagnosis of IPF within 7 years of screening - Female and males = 40 years of age For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort - Evidence of progressive ILD within the 24 months before screening - Female and male = 21 years of age. Exclusion Criteria: - Women of childbearing potential (WOCBP) - Active Smokers - Current malignancy or previous malignancy up to 5 years prior to screening - History of allergy to BMS-986278 or related compounds Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0048 | Buenos Aires | |
| Argentina | Local Institution - 0049 | Buenos Aires | Distrito Federal |
| Argentina | Local Institution - 0115 | Buenos AIres | |
| Argentina | Local Institution - 0122 | Mendoza | |
| Argentina | Local Institution - 0103 | Rosario | Santa FE |
| Argentina | Local Institution - 0097 | San Miguel de Tucuman | Tucuman |
| Australia | Local Institution - 0022 | Adelaide | South Australia |
| Australia | Local Institution - 0026 | Brisbane | Queensland |
| Australia | Local Institution - 0045 | Camperdown | New South Wales |
| Australia | Local Institution - 0046 | Greenslopes | Queensland |
| Australia | Local Institution - 0023 | Heidelberg | Victoria |
| Australia | Local Institution - 0021 | Murdoch | Western Australia |
| Australia | Local Institution - 0044 | Nedlands | Western Australia |
| Australia | Local Institution - 0025 | Westmead | New South Wales |
| Belgium | Local Institution - 0074 | Brussels | |
| Belgium | Local Institution - 0065 | Leuven | |
| Belgium | Local Institution - 0051 | Liège | |
| Brazil | Local Institution | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution - 0076 | Sao Paulo | |
| Brazil | Local Institution | São Paulo | SAO Paulo |
| Brazil | Local Institution | São Paulo | SAO Paulo |
| Canada | Local Institution - 0094 | Montréal | Quebec |
| Canada | Local Institution - 0127 | Quebec | |
| Canada | Local Institution - 0144 | Sherbrooke | Quebec |
| Canada | Local Institution - 0134 | Toronto | Ontario |
| Canada | Local Institution | Vancouver | British Columbia |
| Canada | Local Institution - 0141 | Vancouver | British Columbia |
| Chile | Local Institution - 0108 | Curicó | Maule |
| Chile | Local Institution - 0038 | Quillota | Valparaiso |
| Chile | Local Institution - 0054 | Talca | Maule |
| China | Local Institution - 0183 | Beijing | Beijing |
| China | Local Institution - 0187 | Beijing | Beijing |
| China | Local Institution - 0189 | Shanghai | Shanghai |
| China | Local Institution - 0188 | Wuhan | Hubei |
| France | Local Institution - 0120 | Bobigny | |
| France | Local Institution - 0066 | Bron | |
| France | Local Institution - 0136 | Dijon | |
| France | Local Institution - 0162 | Marseille | |
| France | Hopital Europeen Georges Pompidou | Paris | |
| France | Local Institution - 0143 | Paris | |
| France | Local Institution - 0067 | Rennes | |
| France | Local Institution - 0132 | Toulouse | |
| Germany | Local Institution - 0107 | Essen | |
| Germany | Local Institution | Freiburg | |
| Germany | Local Institution - 0093 | Grosshansdorf | |
| Germany | Local Institution - 0111 | Hannover | Niedersachsen |
| Germany | Local Institution - 0110 | Heidelberg | |
| Germany | Local Institution - 0121 | Munich | |
| Germany | Local Institution - 0119 | Stuttgart | |
| Israel | Local Institution - 0113 | Haifa | |
| Israel | Local Institution - 0149 | Jerusalem | |
| Israel | Local Institution - 0114 | Petah Tikva | |
| Israel | Local Institution | Ramat Gan | |
| Israel | Local Institution - 0145 | Tel Aviv | |
| Italy | Local Institution - 0073 | Catania | |
| Italy | Local Institution - 0077 | Modena | |
| Italy | Local Institution - 0089 | Monza | |
| Italy | Local Institution - 0072 | Roma | |
| Japan | Local Institution - 0080 | Bunkyo-ku | Tokyo |
| Japan | Local Institution - 0064 | Hamamatasu | Shizuoka |
| Japan | Local Institution - 0128 | Izumo | Shimane |
| Japan | Local Institution - 0095 | Kobe | Hyogo |
| Japan | Local Institution - 0169 | Kobe | Hyogo |
| Japan | Local Institution - 0106 | Koriyama | Fukushima |
| Japan | Local Institution - 0117 | Kumamoto | |
| Japan | Local Institution - 0153 | Minato-ku | Tokyo |
| Japan | Local Institution - 0146 | Nagasaki | |
| Japan | Local Institution - 0170 | Saitama | |
| Japan | Local Institution - 0112 | Sakai | Osaka |
| Japan | Local Institution - 0180 | Sapporo | Hokkaido |
| Japan | Local Institution - 0155 | Seto | Aichi |
| Japan | Local Institution - 0177 | Shinjyuku-ku | Tokyo |
| Japan | Local Institution - 0173 | Tokyo | |
| Japan | Local Institution - 0071 | Yokohama | Kanagawa |
| Korea, Republic of | Local Institution | Seoul | |
| Korea, Republic of | Local Institution - 0086 | Seoul | |
| Korea, Republic of | Local Institution - 0087 | Seoul | |
| Mexico | Local Institution | Mexico | Distrito Federal |
| Mexico | Local Institution - 0081 | Monterrey | Nuevo LEON |
| Mexico | Local Institution - 0109 | Monterrey, N.l. | Nuevo Leon |
| Mexico | Local Institution - 0156 | Oaxaca de Juarez | Oaxaca |
| Mexico | Local Institution - 0083 | San Nicolas de los Garza | Nuevo LEON |
| Spain | Local Institution | Barcelona | |
| Spain | Local Institution - 0116 | Barcelona | |
| Spain | Local Institution - 0140 | L'Hospitalet de Llobregat | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution - 0137 | Madrid | |
| Spain | Local Institution | Marbella Málaga | |
| Spain | Local Institution - 0039 | Pozuelo de Alarcon | |
| Spain | Local Institution - 0147 | Santander | |
| Taiwan | Local Institution - 0176 | Kaohsiung | |
| Taiwan | Local Institution - 0174 | Taipei | |
| Taiwan | Local Institution - 0175 | Taipei | |
| United Kingdom | Local Institution - 0050 | Cambridge | |
| United Kingdom | Local Institution - 0163 | Edinburgh | |
| United Kingdom | Local Institution | London | |
| United Kingdom | Local Institution - 0041 | London | |
| United Kingdom | Local Institution - 0092 | London | |
| United States | Local Institution - 0078 | Atlanta | Georgia |
| United States | University of Colorado Anschutz Medical Campus-Department of Medicine | Aurora | Colorado |
| United States | Local Institution - 0154 | Baltimore | Maryland |
| United States | Local Institution - 0032 | Birmingham | Alabama |
| United States | Local Institution - 0003 | Boston | Massachusetts |
| United States | Local Institution - 0096 | Charlottesville | Virginia |
| United States | Local Institution - 0030 | Chesterfield | Missouri |
| United States | Local Institution - 0029 | Cincinnati | Ohio |
| United States | Local Institution - 0164 | Columbus | Ohio |
| United States | Local Institution - 0006 | Denver | Colorado |
| United States | Local Institution | Falls Church | Virginia |
| United States | Local Institution - 0035 | Gainesville | Florida |
| United States | Local Institution | Hershey | Pennsylvania |
| United States | Local Institution - 0031 | Kansas City | Kansas |
| United States | Local Institution - 0028 | Los Angeles | California |
| United States | Local Institution | Nashville | Tennessee |
| United States | Local Institution - 0171 | New Haven | Connecticut |
| United States | Central Florida Pulmonary Group-Research | Orlando | Florida |
| United States | Local Institution | Phoenix | Arizona |
| United States | Local Institution - 0036 | Saint Louis | Missouri |
| United States | Local Institution - 0043 | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants | Up to week 26 | ||
| Secondary | Incidence of Adverse Events (AEs) | Up to 26 weeks | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Up to 26 weeks | ||
| Secondary | Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment | Up to 26 weeks | ||
| Secondary | Incidence of Treatment-Emergent Deaths | Up to 26 weeks | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 26 weeks | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 26 weeks | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 26 weeks | ||
| Secondary | Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 26 weeks | |
| Secondary | Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization | Up to 26 weeks | |
| Secondary | Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 26 weeks | |
| Secondary | Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to 26 weeks | |
| Secondary | Incidence of clinically significant changes in vital signs: Body temperature | Up to 26 weeks | ||
| Secondary | Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 26 weeks | ||
| Secondary | Incidence of clinically significant changes in vital signs: Blood pressure | Up to 26 weeks | ||
| Secondary | Incidence of clinically significant changes in vital signs: Heart rate | Up to 26 weeks | ||
| Secondary | Incidence of clinically significant changes in physical examination findings | Up to 26 weeks | ||
| Secondary | Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants | Up to 26 weeks | ||
| Secondary | Proportion of participants with = 10% absolute decline in ppFVC (%) | At weeks 4, 8, 12, 16, 20, and 26 | ||
| Secondary | Proportion of participants with > 0% change in ppFVC | At weeks 4, 8, 12, 16, 20, and 26 | ||
| Secondary | Time to first acute exacerbation | Up to 26 weeks | ||
| Secondary | Time to first = 10% absolute decline in ppFVC (%) | Up to 26 weeks | ||
| Secondary | Absolute change in FVC (mL) from baseline to Week 26 | Up to 26 weeks | ||
| Secondary | Absolute change in ppFVC (%) from baseline to Week 26 | Up to 26 weeks | ||
| Secondary | Absolute change in single-breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26 | Up to 26 weeks | ||
| Secondary | Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26 | Up to 26 weeks | ||
| Secondary | Change in walking endurance/distance from baseline at Week 26 as measured using the 6-Minute Walk Test (6MWT) | Up to 26 weeks | ||
| Secondary | Proportion of participants with acute exacerbations of lung fibrosis | Up to 26 weeks | ||
| Secondary | Maximum observed concentration (Cmax) of BMS-986278 | Day 1 and Week 4 | ||
| Secondary | Time of maximum observed concentration (Tmax) of BMS-986278 | Day 1 and Week 4 | ||
| Secondary | Area under the plasma concentration-time curve form time 0 to 8 hours post dose of BMS-986278 (AUC(0-8)) | Day 1 and Week 4 | ||
| Secondary | Trough observed plasma concentration (Ctrough) of BMS-986278 | Week 4 and Week 12 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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