RECEPTIVE-CD1NCT07753850

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

StatusRecruiting

PhasePhase 2

SponsorShattuck Labs, Inc.

Primary completionJul 2028 (estimated)

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

Minor Nov 9, 2026 Start date changed from estimate of Oct 21, 2026 to Nov 9, 2026
- Site details revised at 2 of 20 sites
Notable Oct 30, 2026 Recruitment opened Show 4 more changesShow less
- Eligibility criteria expanded, about 13 words
- Trial sites expanded: 0 → 20 locations
- Start date: Oct 2026 to Oct 21, 2026
- Secondary endpoints: details revised at 1 of 3 entries
Minor Aug 10, 2026 Study title shortened, about 2 wordsv2
Aug 4, 2026 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Proportion of participants who achieve endoscopic response

Timeframe: Week 12

Secondary (3)

Proportion of participants who achieve clinical remission

Incidence and severity of treatment-emergent adverse events

Number of participants who discontinue study intervention due to an TEAE

Arms and interventions

SL-325 high doseExperimental

SL-325 mid doseExperimental

SL-325 low doseExperimental

PlaceboPlacebo comparator

Drugs: SL-325, Placebo

Sites

20 sites in 1 country

About this trial

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.

Trial details

Enrollment: 232 participants (estimated)
Started: Nov 9, 2026
Study completion: Jun 2030 (estimated)
Eligibility: 18 to 80, all sexes, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Crohn Disease, Crohn's Disease
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SL-325 in Participants With Moderately to Severely Active Crohn's Disease
First posted: Aug 10, 2026
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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