Trial Outcomes & Findings for Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure (NCT NCT04318093)

Last Updated: 2022-08-04

Results Overview

Clinically Relevant Hypotension is defined as occurrence of any of the following: * Supine Systolic Blood Pressure (SBP) \<85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension * Supine SBP \<90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

From first dose to 30 days following first dose

Results posted on

2022-08-04

Participant Flow

25 participants were randomized and treated.

Participant milestones

Participant milestones
Measure	Placebo Placebo matching BMS-986259	BMS-986259 3 mg BMS-986259 administered subcutaneously QD for 14 days
Overall Study STARTED	13	12
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matching BMS-986259	BMS-986259 3 mg BMS-986259 administered subcutaneously QD for 14 days
Overall Study Adverse Event	2	2
Overall Study Participant withdrew consent	1	0
Overall Study Other reasons	0	1

Baseline Characteristics

Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=13 Participants Placebo matching BMS-986259	BMS-986259 3 mg n=12 Participants BMS-986259 administered subcutaneously QD for 14 days	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	65.1 Years STANDARD_DEVIATION 12.18 • n=5 Participants	63.1 Years STANDARD_DEVIATION 15.65 • n=7 Participants	64.1 Years STANDARD_DEVIATION 13.69 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days following first dose

Population: All treated participants

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Placebo matching BMS-986259	BMS-986259 3 mg n=12 Participants BMS-986259 administered subcutaneously QD for 14 days
Percentage of Participants Experiencing Clinically Relevant Hypotension	15.4 Percent of participants	16.7 Percent of participants

SECONDARY outcome

Timeframe: Day 1 and Day 5 of study treatment

Population: All participants receiving study drug with available measurements

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo matching BMS-986259	BMS-986259 3 mg BMS-986259 administered subcutaneously QD for 14 days
Maximum Observed Serum Concentration (Cmax) Day 1	105 ng/mL Geometric Coefficient of Variation 49	—
Maximum Observed Serum Concentration (Cmax) Day 5	268 ng/mL Geometric Coefficient of Variation 31	—

SECONDARY outcome

Timeframe: Day 1 and Day 5 of study treatment

Population: All participants receiving study drug with available measurements

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo matching BMS-986259	BMS-986259 3 mg BMS-986259 administered subcutaneously QD for 14 days
Time of Maximum Observed Serum Concentration (Tmax) Day 1	11.0 Hours Interval 7.0 to 23.3	—
Time of Maximum Observed Serum Concentration (Tmax) Day 5	7.97 Hours Interval 5.0 to 24.0	—

SECONDARY outcome

Timeframe: Day 1 and Day 5 of study treatment

Population: All participants receiving study drug with available measurements

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo matching BMS-986259	BMS-986259 3 mg BMS-986259 administered subcutaneously QD for 14 days
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) Day 1	1778 h*ng/mL Geometric Coefficient of Variation 40	—
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) Day 5	5156 h*ng/mL Geometric Coefficient of Variation 36	—

SECONDARY outcome

Timeframe: Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)

Population: All participants receiving study drug with available measurements

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Placebo matching BMS-986259	BMS-986259 3 mg BMS-986259 administered subcutaneously QD for 14 days
Trough Concentration (Ctrough) Day 2	79.9 ng/mL Geometric Coefficient of Variation 36.0	—
Trough Concentration (Ctrough) Day 3	145 ng/mL Geometric Coefficient of Variation 32.3	—
Trough Concentration (Ctrough) Day 4	181 ng/mL Geometric Coefficient of Variation 28.9	—
Trough Concentration (Ctrough) Day 5	185 ng/mL Geometric Coefficient of Variation 32.4	—
Trough Concentration (Ctrough) Day 6	210 ng/mL Geometric Coefficient of Variation 27.3	—
Trough Concentration (Ctrough) Day 7	260 ng/mL Geometric Coefficient of Variation 41.3	—
Trough Concentration (Ctrough) Day 8	226 ng/mL Geometric Coefficient of Variation 69.4	—
Trough Concentration (Ctrough) Day 9	252 ng/mL Geometric Coefficient of Variation 48.1	—
Trough Concentration (Ctrough) Day 10	259 ng/mL Geometric Coefficient of Variation 49.7	—
Trough Concentration (Ctrough) Day 12	229 ng/mL Geometric Coefficient of Variation 22.9	—
Trough Concentration (Ctrough) Day 13	248 ng/mL Geometric Coefficient of Variation 50.5	—
Trough Concentration (Ctrough) Day 14	246 ng/mL Geometric Coefficient of Variation 7.53	—

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 3 other events

Deaths: 2 deaths

BMS986259 3 mg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=13 participants at risk Placebo matching BMS-986259	BMS986259 3 mg n=12 participants at risk BMS-986259 administered subcutaneously QD for 14 days
Cardiac disorders Cardiac failure	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Cardiac disorders Cardiac failure chronic	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Cardiac disorders Cardiogenic shock	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Cardiac disorders Ventricular tachycardia	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Infections and infestations COVID-19	0.00% 0/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Infections and infestations COVID-19 pneumonia	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.

Other adverse events

Other adverse events
Measure	Placebo n=13 participants at risk Placebo matching BMS-986259	BMS986259 3 mg n=12 participants at risk BMS-986259 administered subcutaneously QD for 14 days
Blood and lymphatic system disorders Haemoconcentration	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Cardiac disorders Sinus tachycardia	0.00% 0/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Infections and infestations Pneumonia	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Investigations Blood creatinine increased	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Nervous system disorders Dizziness	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Vascular disorders Hypotension	7.7% 1/13 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.	25.0% 3/12 • All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER