Clinical Trials Register

Summary
EudraCT Number:	2019-003992-21
Sponsor's Protocol Code Number:	IM027-040
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-05-27
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2019-003992-21

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.3.2

Name or abbreviated title of the trial where available

Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis

A.4.1

Sponsor's protocol code number

IM027-040

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1241-6174

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	Head of the GSM-CT
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance, Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BMS-986278
D.3.2	Product code	BMS-986278
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LPA1
D.3.9.2	Current sponsor code	BMS-986278
D.3.9.3	Other descriptive name	BMS-986278
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BMS-986278
D.3.2	Product code	BMS-986278
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LPA1
D.3.9.2	Current sponsor code	BMS-986278
D.3.9.3	Other descriptive name	BMS-986278
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pulmonary Fibrosis

E.1.1.1

Medical condition in easily understood language

Pulmonary Fibrosis

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10037383
E.1.2	Term	Pulmonary fibrosis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10021240
E.1.2	Term	Idiopathic pulmonary fibrosis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

_To evaluate the rate of change in percent predicted forced vital capacity (ppFVC)

E.2.2

Secondary objectives of the trial

_To evaluate the safety and tolerability of BMS-986278
_To evaluate the rate of change in ppFVC;
_To evaluate the effect of treatment with BMS-986278 on clinical assessments;
_To characterize the PK of BMS-986278 in IPF participants.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

_Intensive PK Substudy:
An intensive PK substudy will be conducted in approximately 25% of IPF participants in each dose group, for which serial PK samples, ECGs, and BP and HR measurements will be collected (see details in Table 6 of the protocol).
In addition to assessing concentrations of BMS-986278 and the BMT-323719 metabolite, additional PK samples will be collected predose and will be used to analyze for concentrations of pirfenidone or nintedanib by validated assays in participants that receive these medications.
Key PK parameters to be assessed in the intensive PK sampling study include: Cmax, Tmax, AUC(0-8), Ctrough.
Individual participant PK parameter values will be derived by noncompartmental methods by a validated PK analysis program.
Concentration data from this study may be combined with data from the Phase 1 studies in healthy subjects to further characterize the PK of BMS-986278 using population PK analysis.
The relationship between measures of exposure and endpoints for efficacy and safety may also be explored using model-based exposure-response analysis. Results of these analyses will be reported separately.

E.3

Principal inclusion criteria

For the idiopathic pulmonary fibrosis (IPF) Cohort:
- Diagnosis of IPF within 7 years
- 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.

E.4

Principal exclusion criteria

_Women who are of childbearing potential
_Active Smokers
_Patients with current malignancy
_ History of allergy to BMS-986278 or related compounds

E.5 End points

E.5.1

Primary end point(s)

_Rate of change in ppFVC (%) from baseline to Week 26 in IPF participants.

E.5.1.1

Timepoint(s) of evaluation of this end point

_W26

E.5.2

Secondary end point(s)

_AEs, SAEs, AEs leading to early discontinuation of study treatment, Treatment-emergent deaths, Clinical laboratory findings and ECGs, Vital signs, Physical exam findings up to 26 weeks;
_Rate of change in ppFVC (%) from baseline to Week 26 in PF-ILD participants;
_Proportion of participants with ≥ 10% absolute decline in ppFVC (%) at Weeks 4, 8, 12, 16, 20 and 26;
- Proportion of participants with > 0% change in ppFVC at Weeks 4, 8, 12, 16, 20, and 26
− Time to first acute exacerbation
_Time to first ≥ 10% absolute decline in ppFVC (%) up to 26 weeks;
_Absolute change in FVC (mL) from baseline to Week 26;
_Absolute change in ppFVC (%) from baseline to Week 26;
_Absolute change in 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 6MWT;
_Proportion of participants with acute exacerbations (evidence of which will be captured in the eCRF) of lung fibrosis up to Week 26;
_Cmax, Tmax, and AUC(0-8) on Day 1 and Week 4 and Ctrough on Week 4 and Week 12 of intensive PK substudy

E.5.2.1

Timepoint(s) of evaluation of this end point

_all through the duration of the study;
_W26;
_Weeks 4, 8, 12, 16, and 26 or W26;
_day 1 or W4 or W12

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Brazil

Canada

Chile

Israel

Japan

Korea, Republic of

Mexico

Taiwan

United States

France

Spain

Germany

Italy

Belgium

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The last day of the main study will occur when the last participant has completed the follow-up visit (28 ± 7 days after the Week 26 visit). Participants will be considered to have completed the main study if they complete 26 weeks of evaluation.

The last participant visit of the OTE is defined as the last visit or scheduled procedure for the last participant, whichever occurs last. This last participant visit will be the last visit for the entire study.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

270

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

108

F.4.2.2

In the whole clinical trial

360

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-08-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-09-22

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