Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03920267
• Date of registration: 27/03/2019
• Prospective Registration: No
• Primary sponsor: Bristol-Myers Squibb
• Public title: Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
• Scientific title: A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
• Date of first enrolment: March 26, 2019
• Target sample size: 261
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03920267
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Brazil, Canada, Colombia, Germany, Hungary, Israel, Japan, Korea, Republic of, Mexico, Poland, Romania, Russian Federation, Spain, Taiwan, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: BMS-986165

Primary Outcome(s)

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)]

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)]

Secondary ID(s)

2018-003471-35

IM011-074

Source(s) of Monetary Support

Please refer to primary and secondary sponsors