Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus
Brief summary
The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).
Interventions
DRUGBMS-986165
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants who successfully complete the protocol-required treatment period of the Phase 2 SLE study (NCT03252587) will be offered the opportunity to continue this study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product \[IP\] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.
Exclusion criteria
* Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason * Evidence of active tuberculosis (TB) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events | From Day 1 until 30 days after last dose (up to approximately 42 months) | A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes. |
| Number of Participants With Abnormalities in Vital Signs | From Day 1 until 30 days after last dose (up to approximately 42 months) | Vital signs heart rate (HR) (beats/min), systolic blood pressure (SBP) (mmHG), and diastolic blood pressure (DBP) (mmHg). |
| Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities | From Day 1 until 30 days after last dose (up to approximately 42 months) | Blood samples were collected to assess laboratory parameters. Grade 3 = Severe laboratory abnormality Grade 4 = Life-threatening or very severe laboratory abnormality |
Countries
Argentina, Brazil, Canada, Colombia, Hungary, Japan, Mexico, Poland, Romania, Russia, South Korea, Spain, Taiwan, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Participant flow
Pre-assignment details
Qualified participants who completed the study IM011-021 (NCT03252587) were randomized in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.6 years STANDARD_DEVIATION 12.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 12 Participants |
| Race/Ethnicity, Customized Asian | 37 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Others | 7 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 164 Participants |
| Sex: Female, Male Female | 235 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 73 | 1 / 67 | 0 / 21 | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 43 / 58 | 53 / 73 | 51 / 67 | 16 / 21 | 16 / 21 | 16 / 21 |
| serious Total, serious adverse events | 13 / 58 | 9 / 73 | 11 / 67 | 4 / 21 | 0 / 21 | 3 / 21 |
Outcome results
None listed