The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with moderate to severely active Crohn's disease. The study consists of a screening period of up to 6 weeks, a 12-week induction period, 38-week maintenance period, 52-week long-term extension period, and a 10-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
232
Proportion of participants who achieve endoscopic response
The proportion of participants who achieve endoscopic response, as defined by a ≥50% decrease in Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline.
Time frame: Week 12
Proportion of participants who achieve clinical remission
The proportion of participants who achieve clinical remission, as defined by a Crohn's Disease Activity Index \[CDAI\] score \< 150.
Time frame: Week 12
Incidence and severity of treatment-emergent adverse events
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Week 12
Number of participants who discontinue study intervention due to an TEAE
Treatment-emergent adverse events (TEAEs) leading to discontinuation of study intervention
Time frame: Week 12
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