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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06025578




Registration number
NCT06025578
Ethics application status
Date submitted
30/08/2023
Date registered
6/09/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
Scientific title
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
Secondary ID [1] 0 0
2023-503699-25
Secondary ID [2] 0 0
IM027-1015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressive 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
Treatment: Drugs - BMS-986278
Treatment: Drugs - BMS-986278 Placebo

Experimental: BMS-986278 Dose 1 -

Experimental: BMS-986278 Dose 2 -

Placebo comparator: BMS-986278 Placebo -


Treatment: Drugs: BMS-986278
Specified dose on specified days

Treatment: Drugs: BMS-986278 Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants that experience spontaneous syncopal events
Timepoint [1] 0 0
At approximately 4 weeks
Primary outcome [2] 0 0
Absolute change from baseline in forced vital capacity (FVC) measured in mL
Timepoint [2] 0 0
At Week 52
Secondary outcome [1] 0 0
Number of participants who discontinued treatment due to any low BP-related Adverse Events
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Disease progression
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
Timepoint [3] 0 0
At Week 52 and up to approximately 3 years
Secondary outcome [4] 0 0
Change from baseline in L-PF dyspnea domain score
Timepoint [4] 0 0
At Week 52 and up to approximately 3 years
Secondary outcome [5] 0 0
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
Timepoint [5] 0 0
At Week 52
Secondary outcome [6] 0 0
Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first respiratory-related hospitalization, or all-cause mortality
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Time to absolute percent ppFVC decline of = 10% from baseline
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Time to first acute exacerbation of pulmonary fibrosis
Timepoint [8] 0 0
Up to approximately 3 years
Secondary outcome [9] 0 0
Time to first respiratory-related hospitalization
Timepoint [9] 0 0
Up to approximately 3 years
Secondary outcome [10] 0 0
Time to first pulmonary fibrosis-related hospitalization.
Timepoint [10] 0 0
Up to approximately 3 years
Secondary outcome [11] 0 0
Time to all-cause mortality
Timepoint [11] 0 0
Up to approximately 3 years
Secondary outcome [12] 0 0
Change from baseline in L-PF fatigue domain score
Timepoint [12] 0 0
At Week 52 and up to approximately 3 years
Secondary outcome [13] 0 0
Change from baseline in L-PF impacts module score
Timepoint [13] 0 0
At Week 52 and up to approximately 3 years
Secondary outcome [14] 0 0
Change from baseline in cough numeric rating scale (NRS)
Timepoint [14] 0 0
At Week 52 and up to approximately 3 years
Secondary outcome [15] 0 0
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
Timepoint [15] 0 0
At Week 52
Secondary outcome [16] 0 0
Change from baseline in EQ-5D-5L visual analog scale score
Timepoint [16] 0 0
At Week 52
Secondary outcome [17] 0 0
Rate of decline from baseline in FVC (mL)
Timepoint [17] 0 0
At Week 52
Secondary outcome [18] 0 0
Rate of decline in ppFVC from baseline
Timepoint [18] 0 0
At Week 52
Secondary outcome [19] 0 0
Change in ppFVC from baseline
Timepoint [19] 0 0
At Week 52
Secondary outcome [20] 0 0
Proportion of participants with absolute decline in ppFVC =10%
Timepoint [20] 0 0
At Week 52
Secondary outcome [21] 0 0
Proportion of participants with relative decline in ppFVC =10%
Timepoint [21] 0 0
At Week 52
Secondary outcome [22] 0 0
Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)
Timepoint [22] 0 0
At Week 52
Secondary outcome [23] 0 0
Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline
Timepoint [23] 0 0
At Week 52
Secondary outcome [24] 0 0
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
Timepoint [24] 0 0
At Week 52
Secondary outcome [25] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [25] 0 0
Up to 28 days after last dose
Secondary outcome [26] 0 0
Number of participants with Serious AEs (SAEs)
Timepoint [26] 0 0
Up to 28 days after last dose
Secondary outcome [27] 0 0
Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)
Timepoint [27] 0 0
Up to 28 days after last dose
Secondary outcome [28] 0 0
Number of participants with AEs related to IMP
Timepoint [28] 0 0
Up to 28 days after last dose
Secondary outcome [29] 0 0
Number of treatment-emergent deaths
Timepoint [29] 0 0
Up to 28 days after last dose
Secondary outcome [30] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [30] 0 0
Up to 28 days after last dose
Secondary outcome [31] 0 0
Number of participants with electrocardiogram (ECG) abnormalities
Timepoint [31] 0 0
Up to 28 days after last dose
Secondary outcome [32] 0 0
Number of participants with vital sign abnormalities
Timepoint [32] 0 0
Up to 28 days after last dose

Eligibility
Key inclusion criteria
Inclusion Criteria

* Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and = 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
* If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
* If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
* Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
* Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
* Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening.
* Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
* Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
* History of stroke or transient ischemic attack within 3 months prior to screening.
* Participants who exhibit symptoms of heart failure at rest.
* Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
* Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
* 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/12/2027
Actual
Sample size
Target
1092
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0467 - Darlinghurst
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Local Institution - 0090 - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0499 - Chermside
Recruitment hospital [6] 0 0
Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) - Greenslopes
Recruitment hospital [7] 0 0
Mater Misericordiae Limited - South Brisbane
Recruitment hospital [8] 0 0
Local Institution - 0275 - Adelaide
Recruitment hospital [9] 0 0
Eastern Health - Box Hill
Recruitment hospital [10] 0 0
Local Institution - 0299 - Heidelberg,VIC
Recruitment hospital [11] 0 0
Local Institution - 0059 - Melbourne
Recruitment hospital [12] 0 0
Local Institution - 0303 - Murdoch
Recruitment hospital [13] 0 0
Local Institution - 0459 - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg,VIC
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
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Arizona
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Delaware
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India
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UP
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India
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India
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UT
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India
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WB
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India
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Ahmedabad
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India
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LH
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Israel
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D
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Israel
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HA
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Israel
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M
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Israel
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TA
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Israel
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Haifa
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Israel
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RM
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TS
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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United Kingdom
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EDH
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Birmingham

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06025578