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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04308681




Registration number
NCT04308681
Ethics application status
Date submitted
12/03/2020
Date registered
16/03/2020
Date last updated
24/10/2023

Titles & IDs
Public title
A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
Scientific 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
Secondary ID [1] 0 0
2019-003992-21
Secondary ID [2] 0 0
IM027-040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BMS-986278 Placebo
Treatment: Drugs - BMS-986278

Experimental: IPF Dose 1 + Post Treatment Follow-up or OTE - IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)

Experimental: IPF Dose 2 + Post Treatment Follow-up or OTE -

Placebo Comparator: IPF Placebo + Post Treatment Follow-up or OTE -

Experimental: PF-ILD Dose 1 + Post Treatment Follow-up or OTE - PF-ILD (Progressive Fibrotic Interstitial Lung Disease)

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

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


Other interventions: BMS-986278 Placebo
Specified Dose on Specified Days

Treatment: Drugs: BMS-986278
Specified Dose on Specified Days
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants
Timepoint [1] 0 0
Up to week 26
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 26 weeks
Secondary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 26 weeks
Secondary outcome [3] 0 0
Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment
Timepoint [3] 0 0
Up to 26 weeks
Secondary outcome [4] 0 0
Incidence of Treatment-Emergent Deaths
Timepoint [4] 0 0
Up to 26 weeks
Secondary outcome [5] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [5] 0 0
Up to 26 weeks
Secondary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [6] 0 0
Up to 26 weeks
Secondary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [7] 0 0
Up to 26 weeks
Secondary outcome [8] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Timepoint [8] 0 0
Up to 26 weeks
Secondary outcome [9] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Timepoint [9] 0 0
Up to 26 weeks
Secondary outcome [10] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Timepoint [10] 0 0
Up to 26 weeks
Secondary outcome [11] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Timepoint [11] 0 0
Up to 26 weeks
Secondary outcome [12] 0 0
Incidence of clinically significant changes in vital signs: Body temperature
Timepoint [12] 0 0
Up to 26 weeks
Secondary outcome [13] 0 0
Incidence of clinically significant changes in vital signs: Respiratory rate
Timepoint [13] 0 0
Up to 26 weeks
Secondary outcome [14] 0 0
Incidence of clinically significant changes in vital signs: Blood pressure
Timepoint [14] 0 0
Up to 26 weeks
Secondary outcome [15] 0 0
Incidence of clinically significant changes in vital signs: Heart rate
Timepoint [15] 0 0
Up to 26 weeks
Secondary outcome [16] 0 0
Incidence of clinically significant changes in physical examination findings
Timepoint [16] 0 0
Up to 26 weeks
Secondary outcome [17] 0 0
Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants
Timepoint [17] 0 0
Up to 26 weeks
Secondary outcome [18] 0 0
Proportion of participants with = 10% absolute decline in ppFVC (%)
Timepoint [18] 0 0
At weeks 4, 8, 12, 16, 20, and 26
Secondary outcome [19] 0 0
Proportion of participants with > 0% change in ppFVC
Timepoint [19] 0 0
At weeks 4, 8, 12, 16, 20, and 26
Secondary outcome [20] 0 0
Time to first acute exacerbation
Timepoint [20] 0 0
Up to 26 weeks
Secondary outcome [21] 0 0
Time to first = 10% absolute decline in ppFVC (%)
Timepoint [21] 0 0
Up to 26 weeks
Secondary outcome [22] 0 0
Absolute change in FVC (mL) from baseline to Week 26
Timepoint [22] 0 0
Up to 26 weeks
Secondary outcome [23] 0 0
Absolute change in ppFVC (%) from baseline to Week 26
Timepoint [23] 0 0
Up to 26 weeks
Secondary outcome [24] 0 0
Absolute change in single-breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26
Timepoint [24] 0 0
Up to 26 weeks
Secondary outcome [25] 0 0
Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26
Timepoint [25] 0 0
Up to 26 weeks
Secondary outcome [26] 0 0
Change in walking endurance/distance from baseline at Week 26 as measured using the 6-Minute Walk Test (6MWT)
Timepoint [26] 0 0
Up to 26 weeks
Secondary outcome [27] 0 0
Proportion of participants with acute exacerbations of lung fibrosis
Timepoint [27] 0 0
Up to 26 weeks
Secondary outcome [28] 0 0
Maximum observed concentration (Cmax) of BMS-986278
Timepoint [28] 0 0
Day 1 and Week 4
Secondary outcome [29] 0 0
Time of maximum observed concentration (Tmax) of BMS-986278
Timepoint [29] 0 0
Day 1 and Week 4
Secondary outcome [30] 0 0
Area under the plasma concentration-time curve form time 0 to 8 hours post dose of BMS-986278 (AUC(0-8))
Timepoint [30] 0 0
Day 1 and Week 4
Secondary outcome [31] 0 0
Trough observed plasma concentration (Ctrough) of BMS-986278
Timepoint [31] 0 0
Week 4 and Week 12

Eligibility
Key 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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2023
Sample size
Target
Accrual to date
Final
399
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0045 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0025 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0026 - Brisbane
Recruitment hospital [4] 0 0
Local Institution - 0046 - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - 0022 - Adelaide
Recruitment hospital [6] 0 0
Local Institution - 0023 - Heidelberg
Recruitment hospital [7] 0 0
Local Institution - 0021 - Murdoch
Recruitment hospital [8] 0 0
Local Institution - 0044 - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4032 - Brisbane
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Distrito Federal
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa FE
Country [18] 0 0
Argentina
State/province [18] 0 0
Tucuman
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos AIres
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Mendoza
Country [22] 0 0
Belgium
State/province [22] 0 0
Brussels
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Belgium
State/province [24] 0 0
Liège
Country [25] 0 0
Brazil
State/province [25] 0 0
RIO Grande DO SUL
Country [26] 0 0
Brazil
State/province [26] 0 0
SAO Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Chile
State/province [31] 0 0
Maule
Country [32] 0 0
Chile
State/province [32] 0 0
Valparaiso
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Hubei
Country [35] 0 0
China
State/province [35] 0 0
Shanghai
Country [36] 0 0
France
State/province [36] 0 0
Bobigny
Country [37] 0 0
France
State/province [37] 0 0
Bron
Country [38] 0 0
France
State/province [38] 0 0
Dijon
Country [39] 0 0
France
State/province [39] 0 0
Marseille
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Rennes
Country [42] 0 0
France
State/province [42] 0 0
Toulouse
Country [43] 0 0
Germany
State/province [43] 0 0
Niedersachsen
Country [44] 0 0
Germany
State/province [44] 0 0
Essen
Country [45] 0 0
Germany
State/province [45] 0 0
Freiburg
Country [46] 0 0
Germany
State/province [46] 0 0
Grosshansdorf
Country [47] 0 0
Germany
State/province [47] 0 0
Heidelberg
Country [48] 0 0
Germany
State/province [48] 0 0
Munich
Country [49] 0 0
Germany
State/province [49] 0 0
Stuttgart
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
State/province [52] 0 0
Petah Tikva
Country [53] 0 0
Israel
State/province [53] 0 0
Ramat Gan
Country [54] 0 0
Israel
State/province [54] 0 0
Tel Aviv
Country [55] 0 0
Italy
State/province [55] 0 0
Catania
Country [56] 0 0
Italy
State/province [56] 0 0
Modena
Country [57] 0 0
Italy
State/province [57] 0 0
Monza
Country [58] 0 0
Italy
State/province [58] 0 0
Roma
Country [59] 0 0
Japan
State/province [59] 0 0
Aichi
Country [60] 0 0
Japan
State/province [60] 0 0
Fukushima
Country [61] 0 0
Japan
State/province [61] 0 0
Hokkaido
Country [62] 0 0
Japan
State/province [62] 0 0
Hyogo
Country [63] 0 0
Japan
State/province [63] 0 0
Kanagawa
Country [64] 0 0
Japan
State/province [64] 0 0
Osaka
Country [65] 0 0
Japan
State/province [65] 0 0
Shimane
Country [66] 0 0
Japan
State/province [66] 0 0
Shizuoka
Country [67] 0 0
Japan
State/province [67] 0 0
Tokyo
Country [68] 0 0
Japan
State/province [68] 0 0
Kumamoto
Country [69] 0 0
Japan
State/province [69] 0 0
Nagasaki
Country [70] 0 0
Japan
State/province [70] 0 0
Saitama
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Seoul
Country [72] 0 0
Mexico
State/province [72] 0 0
Distrito Federal
Country [73] 0 0
Mexico
State/province [73] 0 0
Nuevo Leon
Country [74] 0 0
Mexico
State/province [74] 0 0
Nuevo LEON
Country [75] 0 0
Mexico
State/province [75] 0 0
Oaxaca
Country [76] 0 0
Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
State/province [77] 0 0
L'Hospitalet de Llobregat
Country [78] 0 0
Spain
State/province [78] 0 0
Madrid
Country [79] 0 0
Spain
State/province [79] 0 0
Marbella Málaga
Country [80] 0 0
Spain
State/province [80] 0 0
Pozuelo de Alarcon
Country [81] 0 0
Spain
State/province [81] 0 0
Santander
Country [82] 0 0
Taiwan
State/province [82] 0 0
Kaohsiung
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Cambridge
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Edinburgh
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04308681
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04308681