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A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

Primary Purpose

Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986278 Placebo
BMS-986278
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Idiopathic pulmonary fibrosis, Progressive Fibrotic Interstitial Lung Disease, Idiopathic interstitial pneumonia, Fibrotic interstitial pneumonia, Fibrotic interstitial lung disease, Fibrosing interstitial lung disease, Interstitial lung disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0032
  • Local Institution
  • Local Institution - 0028
  • Local Institution - 0043
  • University of Colorado Anschutz Medical Campus-Department of Medicine
  • Local Institution - 0006
  • Local Institution - 0171
  • Local Institution - 0035
  • Central Florida Pulmonary Group-Research
  • Local Institution - 0078
  • Local Institution - 0031
  • Local Institution - 0154
  • Local Institution - 0003
  • Local Institution - 0030
  • Local Institution - 0036
  • Local Institution - 0029
  • Local Institution - 0164
  • Local Institution
  • Local Institution
  • Local Institution - 0096
  • Local Institution
  • Local Institution - 0049
  • Local Institution - 0103
  • Local Institution - 0097
  • Local Institution - 0115
  • Local Institution - 0048
  • Local Institution - 0122
  • Local Institution - 0045
  • Local Institution - 0025
  • Local Institution - 0026
  • Local Institution - 0046
  • Local Institution - 0022
  • Local Institution - 0023
  • Local Institution - 0021
  • Local Institution - 0044
  • Local Institution - 0074
  • Local Institution - 0065
  • Local Institution - 0051
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0076
  • Local Institution - 0141
  • Local Institution
  • Local Institution - 0134
  • Local Institution - 0094
  • Local Institution - 0144
  • Local Institution - 0127
  • Local Institution - 0108
  • Local Institution - 0054
  • Local Institution - 0038
  • Local Institution - 0187
  • Local Institution - 0183
  • Local Institution - 0188
  • Local Institution - 0189
  • Local Institution - 0120
  • Local Institution - 0066
  • Local Institution - 0136
  • Local Institution - 0162
  • Hopital Europeen Georges Pompidou
  • Local Institution - 0143
  • Local Institution - 0067
  • Local Institution - 0132
  • Local Institution - 0111
  • Local Institution - 0107
  • Local Institution
  • Local Institution - 0093
  • Local Institution - 0110
  • Local Institution - 0121
  • Local Institution - 0119
  • Local Institution - 0113
  • Local Institution - 0149
  • Local Institution - 0114
  • Local Institution
  • Local Institution - 0145
  • Local Institution - 0073
  • Local Institution - 0077
  • Local Institution - 0089
  • Local Institution - 0072
  • Local Institution - 0155
  • Local Institution - 0106
  • Local Institution - 0180
  • Local Institution - 0095
  • Local Institution - 0169
  • Local Institution - 0071
  • Local Institution - 0112
  • Local Institution - 0128
  • Local Institution - 0064
  • Local Institution - 0080
  • Local Institution - 0153
  • Local Institution - 0177
  • Local Institution - 0117
  • Local Institution - 0146
  • Local Institution - 0170
  • Local Institution - 0173
  • Local Institution - 0087
  • Local Institution - 0086
  • Local Institution
  • Local Institution
  • Local Institution - 0109
  • Local Institution - 0081
  • Local Institution - 0083
  • Local Institution - 0156
  • Local Institution
  • Local Institution - 0116
  • Local Institution - 0140
  • Local Institution
  • Local Institution - 0137
  • Local Institution
  • Local Institution - 0039
  • Local Institution - 0147
  • Local Institution - 0176
  • Local Institution - 0174
  • Local Institution - 0175
  • Local Institution - 0050
  • Local Institution - 0163
  • Local Institution - 0041
  • Local Institution - 0092
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

IPF Dose 1 + Post Treatment Follow-up or OTE

IPF Dose 2 + Post Treatment Follow-up or OTE

IPF Placebo + Post Treatment Follow-up or OTE

PF-ILD Dose 1 + Post Treatment Follow-up or OTE

PF-ILD Dose 2 + Post Treatment Follow-up or OTE

PF-ILD Placebo + Post Treatment Follow-up or OTE

Arm Description

IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)

PF-ILD (Progressive Fibrotic Interstitial Lung Disease)

Outcomes

Primary Outcome Measures

Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants

Secondary Outcome Measures

Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment
Incidence of Treatment-Emergent Deaths
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
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
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
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
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Respiratory rate
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Heart rate
Incidence of clinically significant changes in physical examination findings
Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants
Proportion of participants with ≥ 10% absolute decline in ppFVC (%)
Proportion of participants with > 0% change in ppFVC
Time to first acute exacerbation
Time to first ≥ 10% absolute decline in ppFVC (%)
Absolute change in FVC (mL) from baseline to Week 26
Absolute change in ppFVC (%) from baseline to Week 26
Absolute change in single-breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26
Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26
Change in walking endurance/distance from baseline at Week 26 as measured using the 6-Minute Walk Test (6MWT)
Proportion of participants with acute exacerbations of lung fibrosis
Maximum observed concentration (Cmax) of BMS-986278
Time of maximum observed concentration (Tmax) of BMS-986278
Area under the plasma concentration-time curve form time 0 to 8 hours post dose of BMS-986278 (AUC(0-8))
Trough observed plasma concentration (Ctrough) of BMS-986278

Full Information

First Posted
March 12, 2020
Last Updated
October 19, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04308681
Brief Title
A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
September 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis
Keywords
Idiopathic pulmonary fibrosis, Progressive Fibrotic Interstitial Lung Disease, Idiopathic interstitial pneumonia, Fibrotic interstitial pneumonia, Fibrotic interstitial lung disease, Fibrosing interstitial lung disease, Interstitial lung disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
399 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPF Dose 1 + Post Treatment Follow-up or OTE
Arm Type
Experimental
Arm Description
IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
Arm Title
IPF Dose 2 + Post Treatment Follow-up or OTE
Arm Type
Experimental
Arm Title
IPF Placebo + Post Treatment Follow-up or OTE
Arm Type
Placebo Comparator
Arm Title
PF-ILD Dose 1 + Post Treatment Follow-up or OTE
Arm Type
Experimental
Arm Description
PF-ILD (Progressive Fibrotic Interstitial Lung Disease)
Arm Title
PF-ILD Dose 2 + Post Treatment Follow-up or OTE
Arm Type
Experimental
Arm Title
PF-ILD Placebo + Post Treatment Follow-up or OTE
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
BMS-986278 Placebo
Intervention Description
Specified Dose on Specified Days
Intervention Type
Drug
Intervention Name(s)
BMS-986278
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants
Time Frame
Up to week 26
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 26 weeks
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to 26 weeks
Title
Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment
Time Frame
Up to 26 weeks
Title
Incidence of Treatment-Emergent Deaths
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Description
PR interval: The time from the onset of the P wave to the start of the QRS complex
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Description
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Description
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Description
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame
Up to 26 weeks
Title
Incidence of clinically significant changes in physical examination findings
Time Frame
Up to 26 weeks
Title
Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants
Time Frame
Up to 26 weeks
Title
Proportion of participants with ≥ 10% absolute decline in ppFVC (%)
Time Frame
At weeks 4, 8, 12, 16, 20, and 26
Title
Proportion of participants with > 0% change in ppFVC
Time Frame
At weeks 4, 8, 12, 16, 20, and 26
Title
Time to first acute exacerbation
Time Frame
Up to 26 weeks
Title
Time to first ≥ 10% absolute decline in ppFVC (%)
Time Frame
Up to 26 weeks
Title
Absolute change in FVC (mL) from baseline to Week 26
Time Frame
Up to 26 weeks
Title
Absolute change in ppFVC (%) from baseline to Week 26
Time Frame
Up to 26 weeks
Title
Absolute change in single-breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26
Time Frame
Up to 26 weeks
Title
Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26
Time Frame
Up to 26 weeks
Title
Change in walking endurance/distance from baseline at Week 26 as measured using the 6-Minute Walk Test (6MWT)
Time Frame
Up to 26 weeks
Title
Proportion of participants with acute exacerbations of lung fibrosis
Time Frame
Up to 26 weeks
Title
Maximum observed concentration (Cmax) of BMS-986278
Time Frame
Day 1 and Week 4
Title
Time of maximum observed concentration (Tmax) of BMS-986278
Time Frame
Day 1 and Week 4
Title
Area under the plasma concentration-time curve form time 0 to 8 hours post dose of BMS-986278 (AUC(0-8))
Time Frame
Day 1 and Week 4
Title
Trough observed plasma concentration (Ctrough) of BMS-986278
Time Frame
Week 4 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0032
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Local Institution
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Local Institution - 0028
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Local Institution - 0043
City
Stanford
State/Province
California
ZIP/Postal Code
94305-528
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus-Department of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0006
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Local Institution - 0171
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution - 0035
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Central Florida Pulmonary Group-Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Local Institution - 0078
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Local Institution - 0031
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Local Institution - 0154
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Local Institution - 0003
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Local Institution - 0030
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Local Institution - 0036
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 0029
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Local Institution - 0164
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Local Institution
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Local Institution - 0096
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Local Institution
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Local Institution - 0049
City
Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Local Institution - 0103
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
S2000DTC
Country
Argentina
Facility Name
Local Institution - 0097
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IAR
Country
Argentina
Facility Name
Local Institution - 0115
City
Buenos AIres
ZIP/Postal Code
1056
Country
Argentina
Facility Name
Local Institution - 0048
City
Buenos Aires
ZIP/Postal Code
1638
Country
Argentina
Facility Name
Local Institution - 0122
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Local Institution - 0045
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution - 0025
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 0026
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Local Institution - 0046
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution - 0022
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 0023
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0021
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 0044
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0074
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 0065
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0051
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Local Institution
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Local Institution
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
04520-013
Country
Brazil
Facility Name
Local Institution - 0076
City
Sao Paulo
ZIP/Postal Code
01323020
Country
Brazil
Facility Name
Local Institution - 0141
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Local Institution - 0134
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Local Institution - 0094
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Local Institution - 0144
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Local Institution - 0127
City
Quebec
ZIP/Postal Code
G1V 2G5
Country
Canada
Facility Name
Local Institution - 0108
City
Curicó
State/Province
Maule
ZIP/Postal Code
3341643
Country
Chile
Facility Name
Local Institution - 0054
City
Talca
State/Province
Maule
ZIP/Postal Code
0
Country
Chile
Facility Name
Local Institution - 0038
City
Quillota
State/Province
Valparaiso
ZIP/Postal Code
0
Country
Chile
Facility Name
Local Institution - 0187
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Local Institution - 0183
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Local Institution - 0188
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Local Institution - 0189
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution - 0120
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Local Institution - 0066
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Local Institution - 0136
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Local Institution - 0162
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Local Institution - 0143
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Local Institution - 0067
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution - 0132
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0111
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30459
Country
Germany
Facility Name
Local Institution - 0107
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Local Institution
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution - 0093
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution - 0110
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Local Institution - 0121
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Local Institution - 0119
City
Stuttgart
ZIP/Postal Code
70736
Country
Germany
Facility Name
Local Institution - 0113
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Local Institution - 0149
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Local Institution - 0114
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Local Institution
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Local Institution - 0145
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Local Institution - 0073
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Local Institution - 0077
City
Modena
ZIP/Postal Code
41125
Country
Italy
Facility Name
Local Institution - 0089
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Local Institution - 0072
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution - 0155
City
Seto
State/Province
Aichi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Local Institution - 0106
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-0197
Country
Japan
Facility Name
Local Institution - 0180
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Local Institution - 0095
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution - 0169
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
653-0013
Country
Japan
Facility Name
Local Institution - 0071
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Local Institution - 0112
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Local Institution - 0128
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-0021
Country
Japan
Facility Name
Local Institution - 0064
City
Hamamatasu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Local Institution - 0080
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8510
Country
Japan
Facility Name
Local Institution - 0153
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
Facility Name
Local Institution - 0177
City
Shinjyuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Local Institution - 0117
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Local Institution - 0146
City
Nagasaki
ZIP/Postal Code
852-8102
Country
Japan
Facility Name
Local Institution - 0170
City
Saitama
ZIP/Postal Code
330-8553
Country
Japan
Facility Name
Local Institution - 0173
City
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Local Institution - 0087
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0086
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
06355
Country
Korea, Republic of
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Local Institution - 0109
City
Monterrey, N.l.
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution - 0081
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Local Institution - 0083
City
San Nicolas de los Garza
State/Province
Nuevo LEON
ZIP/Postal Code
66465
Country
Mexico
Facility Name
Local Institution - 0156
City
Oaxaca de Juarez
State/Province
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0116
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 0140
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 0137
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Marbella Málaga
ZIP/Postal Code
29603
Country
Spain
Facility Name
Local Institution - 0039
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Local Institution - 0147
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0176
City
Kaohsiung
ZIP/Postal Code
0
Country
Taiwan
Facility Name
Local Institution - 0174
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution - 0175
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution - 0050
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
Local Institution - 0163
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Local Institution - 0041
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Local Institution - 0092
City
London
ZIP/Postal Code
SW3 6HP
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
WC1E 6JF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34969771
Citation
Corte TJ, Lancaster L, Swigris JJ, Maher TM, Goldin JG, Palmer SM, Suda T, Ogura T, Minnich A, Zhan X, Tirucherai GS, Elpers B, Xiao H, Watanabe H, Smith RA, Charles ED, Fischer A. Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrotic interstitial lung disease (PF-ILD). BMJ Open Respir Res. 2021 Dec;8(1):e001026. doi: 10.1136/bmjresp-2021-001026.
Results Reference
derived
PubMed Identifier
34709814
Citation
Cheng PTW, Kaltenbach RF 3rd, Zhang H, Shi J, Tao S, Li J, Kennedy LJ, Walker SJ, Shi Y, Wang Y, Dhanusu S, Reddigunta R, Kumaravel S, Jusuf S, Smith D, Krishnananthan S, Li J, Wang T, Heiry R, Sum CS, Kalinowski SS, Hung CP, Chu CH, Azzara AV, Ziegler M, Burns L, Zinker BA, Boehm S, Taylor J, Sapuppo J, Mosure K, Everlof G, Guarino V, Zhang L, Yang Y, Ruan Q, Xu C, Apedo A, Traeger SC, Cvijic ME, Lentz KA, Tirucherai G, Sivaraman L, Robl J, Ellsworth BA, Rosen G, Gordon DA, Soars MG, Gill M, Murphy BJ. Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA1) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases. J Med Chem. 2021 Nov 11;64(21):15549-15581. doi: 10.1021/acs.jmedchem.1c01256. Epub 2021 Oct 28.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

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