Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03920267 |
Recruitment Status :
Active, not recruiting
First Posted : April 18, 2019
Last Update Posted : April 26, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: BMS-986165 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 261 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
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. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus |
Actual Study Start Date : | March 26, 2019 |
Estimated Primary Completion Date : | November 27, 2023 |
Estimated Study Completion Date : | November 27, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: BMS-986165 Dose 1 |
Drug: BMS-986165
Specified dose on specified days
Other Name: Deucravacitinib |
Experimental: BMS-986165 Dose 2 |
Drug: BMS-986165
Specified dose on specified days
Other Name: Deucravacitinib |
Experimental: BMS-986165 Dose 3 |
Drug: BMS-986165
Specified dose on specified days
Other Name: Deucravacitinib |
- Number of participants with Adverse Events (AEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
- Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
- Number of participants with AEs leading to discontinuation [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
- Number of participants with abnormal change from baseline in laboratory measurements over time [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
- Number of participants with abnormal change from baseline in vital signs over time [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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/exclusion criteria apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920267

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03920267 |
Other Study ID Numbers: |
IM011-074 2018-003471-35 ( EudraCT Number ) |
First Posted: | April 18, 2019 Key Record Dates |
Last Update Posted: | April 26, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Systemic Lupus Erythematosus |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases BMS-986165 |
Dermatologic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |