臨床研究等提出・公開システム

A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus

Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus (IM011-074)

Hobar Coby

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Hobar Coby

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

completed

Sept. 17, 2019

Interventional

Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment

treatment purpose

2

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.

'-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)

Both

Systemic Lupus Erythematosus

investigational material(s)
Generic name etc : Deucravacitinib
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material :
control material(s)
Generic name etc : placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :

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)]

Not provided

+81-3-3541-5151

July. 11, 2019