臨床研究等提出・公開システム

An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis

Long-term Safety and Efficacy of Deucravacitinib in Participants with Crohn's Disease or Ulcerative Colitis (IM011-077)

67

A total of 67 subjects were enrolled, of which 65 subjects (24 subjects in CD group and 41 subjects in UC group) were treated, and 2 subjects were not treated. No subject was excluded from treatment due to COVID-19. The majority of subjects were male 38 (56.7%), white 59 (88.1%) and < 65 years 59 (88.1%) with a mean age of 42.2 (SD: 15.24) years and a median age of 39.0(range: 20, 74). Mean baseline BMI was 25.90 Kg/m 2 (range: 16.1, 52.3) . Most of the subjects (64.2%), were from the geographic region of Europe, followed by North America (22.4%). The baseline characteristics were representative of the diseases studied. The mean duration of the disease since diagnosis for CD group was 11 years, while UC group was 10 years.

This study was conducted at 73 sites in 26 countries (Australia, Belgium,Brazil, Canada, China,Czech Republic, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation,Spain, Switzerland, Taiwan, United Kingdom,and USA). The study was initiated on 07-May-2021 (FSFV) and completed on 29-Aug-2023 (LSLV) and the database lock occurred on 01-Nov-2023.The planned study duration was 288 weeks, but the current study concluded at 120 weeks because no patient reached week 288 due to the study termination. The sponsor made a business decision to terminate the study as the parent studies failed to meet their primary endpoint; the decision is unrelated to safety.

The safety summary analysis is defined as starting from the date of the first dose of the study treatment and extending up to 30 days after the last dose of the study treatment. 37/65(56.9%) subjects reported with TEAEs. Among these, 18(75.0%) subjects reported TEAEs in the CD group, and the other 19(46.3%) in the UC group. Out of the 37 subjects (56.9%) who reported TEAEs, 7 subjects (10.8%) had TEAEs reported by the investigator as related to the study drug. Among these, 3 (12.5%) subjects were in the CD group (PTs: skin lesion inflammation, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, mouth ulceration, blood creatine phosphokinase increased, immunoglobulins abnormal, neutrophil count decreased)and 4 (9.8%) in the UC group (PTs: tonsilitis, mouth ulceration, acne, infected aural fistula, papule, viral infection). The most frequently reported TEAEs were in the infectious disease SOC followed by gastrointestinal disorders SOC. Two (3.1%) subjects had TEAEs that led to study drug discontinuation (PTs: small intestinal obstruction, urinary tract infection, and colitis ulcerative). No TEAE reported as drug-related led to study drug discontinuation. TEAEs leading to discontinuation were reported in the SOC of gastrointestinal disorders in both groups (CD and UC) followed by SOC of infections and infestations in the CD group. 4/65(6.2%) subjects reported SAEs. Among these, 2 (8.3%) subjects reported SAEs in the CD group (PTs: small intestinal obstruction, urinary tract infection, pneumonia, sepsis), and the other 2 (4.9%) in the UC group (PTs: colitis ulcerative, procedural pneumothorax, cardiac failure chronic, and general physical health deterioration). Additionally, two SAEs were reported during follow-up period in the CD group (systemic inflammatory response syndrome and intestinal obstruction). None of the reported events were related to the study drug. No deaths were reported during the study.

Not applicable since this study is not designed to evaluate efficacy

Subjects entered this open label extension study from their parent studies where they were treated with DEUC 6 mg BID for a minimum of 52 weeks and in the current study during the week 0 to week 288, subjects were treated with DEUC 6 mg BID and showed an acceptable safety profile and was generally well-tolerated in subjects with moderate to severe CD and moderate to severe UC. Overall, no new relevant safety information was identified. The AE profile observed in this study is consistent with the established

Feb. 14, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031210637

Walid Elsharkawi

Bristol-Myers Squibb

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

mg-jp-clinical_trial@bms.com

Walid Elsharkawi

Bristol-Myers Squibb

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

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Complete

Mar. 02, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Previously completed OLE treatment in 1 of the parent CD or UC studies

Any disease or medical condition that, in the opinion of the investigator, would make the participant unsuitable for this study, would interfere with the interpretation of participant safety or study results, or is considered unsuitable by the investigator for any other reason.

Both

Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis

BMS-986165(Deucravacitinib) 6 mg BID

To assess the safety and tolerability of long-term use of BMS-986165(Deucravacitinib)

To assess the effect of long-term use of BMS-986165(Deucravacitinib)

+81-3-3813-6111

Nov. 22, 2021

US/Spain/Germany/Italy/UK/Poland/Czech Republic/Russia/Hungary/Mexico/Taiwan/China/Belgium/Australia/Canada/Denmark/Romania/ South Korea/Ireland/Portugal/France/Switzerland/Israel/Brazil/Netherlands