An Investigational Study to Evaluate the Safety and Effec... | NCT03943147

NCT03943147

ID	Type	Description	Link
2018-004142-42	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-986165 Dose 1	Experimental	Specified Dose on Specified Days	Drug: BMS-986165 Drug: Mycophenolate Mofetil
BMS-986165 Dose 2	Experimental	Specified Dose on Specified Days	Drug: BMS-986165 Drug: Mycophenolate Mofetil
Placebo for BMS-986165	Placebo Comparator	Specified Dose on Specified Days	Drug: Placebo Drug: Mycophenolate Mofetil
Mycophenolate Mofetil (MMF)	Experimental	Specified Dose on Specified Days	Drug: Mycophenolate Mofetil

Name	Type	Description	Arm Group Labels	Other Names
BMS-986165	Drug	Specified dose on specified days	BMS-986165 Dose 1 BMS-986165 Dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)	An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.	From baseline up to 52 weeks after first dose in Part B
The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)	The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.	From baseline up to 52 weeks after first dose in Part B
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)	The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.	From baseline up to 52 weeks after first dose in Part B
The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)	The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

Secondary Outcomes

Measure	Description	Time Frame
The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)	The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-3300	United States
The Nephrology Group

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
FDA Safety Alerts and Recalls

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Open Label MMF	All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks. Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids. The following suggested target doses of MMF should be reached by the time of randomization: 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent 3.0 g/day for participants self-described as Black, African American, or of African descent 2.0 g/day for all others

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 6, 2020

Arm/Group Information

ID	Title	Description
BG000	Open Label MMF	All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks. Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids. The following suggested target doses of MMF should be reached by the time of randomization: 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent 3.0 g/day for participants self-described as Black, African American, or of African descent 2.0 g/day for all others
BG001	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00010 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

All randomized participants in Part B

Posted

Count of Participants

Participants

From baseline up to 52 weeks after first dose in Part B

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG0001

Title

Denominators

Categories

Title	Measurements
	OG0001

Primary

The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)

The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

All randomized participants in Part B

Posted

Count of Participants

Participants

From baseline up to 52 weeks after first dose in Part B

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Primary

The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)

The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

All randomized participants in Part B

Posted

Number

Percent change from baseline

From baseline up to 52 weeks after first dose in Part B

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Primary

The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)

The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

All randomized participants in Part B

Posted

Count of Participants

Participants

From baseline up to 52 weeks after first dose in Part B

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Primary

Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)

The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.

All randomized participants in Part B

Posted

Number

Percent change from baseline

Week 24

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Secondary

The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)

The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.

All randomized participants in Part B

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Secondary

The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)

All randomized participants in Part B

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Secondary

The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)

The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.

All randomized participants in Part B

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Secondary

The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)

All randomized participants in Part B

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Secondary

The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B)

All randomized participants in Part B

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Secondary

The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B)

All randomized participants in Part B

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Open Label MMF	All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks. Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids. The following suggested target doses of MMF should be reached by the time of randomization: 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent 3.0 g/day for participants self-described as Black, African American, or of African descent 2.0 g/day for all others	0	16	1	16	7	16
EG001	Open Label MMF + BMS-986165	After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.	0	1	1	1	1	1

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected1 at risk
Blood pressure increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
International normalised ratio increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected1 at risk
Prothrombin time prolonged	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected1 at risk
Weight increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected1 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected1 at risk

Certain Agreements

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D008180	Lupus Erythematosus, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C000628674	deucravacitinib
D009173	Mycophenolic Acid

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids