An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

Summary

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

Timeline

Start

2017-09-21

Primary completion

2021-06-29

Completion

2021-10-28

Outcome

Met primary endpoint

paper all primary and secondary endpoints were met with the deucravacitinib 3 mg two times per day dose. PMID 40451616 ↗

registry analysis (superiority test); Placebo vs BMS-986165 3 mg; p = 0.0006; Odds Ratio (OR) 2.8 (95% CI 1.5 to 5.1); Regression, Logistic NCT03252587 ↗

Publications

• Mosca M, Arnaud L, Askanase A, Hobar C, Becker B, Singhal S, Banerjee S, Pomponi S, Choi J, Strand V. Deucravacitinib, an oral, selective, allosteric, tyrosine kinase 2 inhibitor, in patients with active SLE: efficacy on patient-reported outcomes in a phase II randomised trial. Lupus Sci Med. 2025 Jun 1;12(1):e001517. doi: 10.1136/lupus-2025-001517.
• Morand E, Pike M, Merrill JT, van Vollenhoven R, Werth VP, Hobar C, Delev N, Shah V, Sharkey B, Wegman T, Catlett I, Banerjee S, Singhal S. Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):242-252. doi: 10.1002/art.42391. Epub 2022 Nov 11.
• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CRAVACITINIB	Small molecule	3 mg	Oral
Subject	CRAVACITINIB	Small molecule	6 mg	Oral
Subject	CRAVACITINIB	Small molecule	12 mg	Oral

Indications