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

JRCT ID: jRCT2031210637

Registered date:02/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis
• Date of first enrollment: 22/03/2022
• Target sample size: 15
• Countries of recruitment: US,Japan,Spain,Japan,Germany,Japan,Italy,Japan,UK,Japan,Poland,Japan,Czech Republic,Japan,Russia,Japan,Hungary,Japan,Mexico,Japan,Taiwan,Japan,China,Japan,Belgium,Japan,Australia,Japan,Canada,Japan,Denmark,Japan,Romania,Japan,South Korea,Japan,Ireland,Japan,Portugal,Japan,France,Japan,Switzerland,Japan,Israel,Japan,Brazil,Japan,Netherlands,Japan
• Study type: Interventional
• Intervention(s): BMS-986165(Deucravacitinib) 6 mg BID

Outcome(s)

• Primary Outcome: To assess the safety and tolerability of long-term use of BMS-986165(Deucravacitinib)
• Secondary Outcome: To assess the effect of long-term use of BMS-986165(Deucravacitinib)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Previously completed OLE treatment in 1 of the parent CD or UC studies
• Exclude criteria: 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.

Related Information

• Primary Sponsor: Walid Elsharkawi
• Secondary ID(s): NCT04877990