A Study of SL-325 in Crohn's Disease Patients

Sponsor
Shattuck Labs, Inc.
Study ID
NCT07753850
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SL-325 — DRUG
    SL-325 administered intravenously
  • Placebo — DRUG
    Placebo administered intravenously

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
232 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SL-325 high dose
  • Experimental: SL-325 mid dose
  • Experimental: SL-325 low dose
  • Placebo Comparator: Placebo

Primary Outcome Measure

Proportion of participants who achieve endoscopic response [ Time Frame: Week 12 ]

Central Contacts

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