A Phase 2 interventional study of SL-325 and Placebo in Crohn's Disease, sponsored by Shattuck Labs, Inc.. Recruiting at 20 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Shattuck Labs, Inc. · Phase 2, Interventional, and Treatment
Among 660 studies in Crohn Disease with a site in United States — 123 open to participants now, 164 under way, 35 of them phase 3. Crohn Disease · United States.
Among the 660 studies in Crohn Disease with a site in United States, this one is the 117th largest by planned enrollment of the 528 interventional ones, is one of 35 that started in 2026, is one of 141 in phase 2, reaches primary completion later than 104 of the 162 other live ones, and was the 655th registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 232 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →123 of the 660 studies in Crohn Disease with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →660 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 35 started in 2026.
Median enrollment 60 across the 528 interventional studies, 168 across the 128 observational. Of the 452 that completed or were terminated, 205 (45%) have results posted.
310 of 660 have an industry lead sponsor. The 10 most frequent:
Shattuck Labs, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Shattuck Labs, Inc. has 1 study filed under Crohn Disease — fewer than ten, so there is no comparison to draw.
59 of the studies in Crohn Disease with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06063967Phase 3AbbVieA Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. | 2027-03 |
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT05660746Phase 3Children's Hospital Medical Center, CincinnatiPrecise Infliximab Exposure and Pharmacodynamic Control | 2027-03-31 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT06227910Phase 3TakedaA Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease | 2027-06-08 |
Among the 660 studies in Crohn Disease with a site in United States, from their registry updates:
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 Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SL-325
Drug: SL-325
Drug: SL-325
Drug: Placebo
SL-325 administered intravenously
Placebo administered intravenously
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
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. Proposals will be reviewed based on scientific need, conflicts of interest, and regulatory approval status.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.
Of 55 industry-sponsored phase 2 interventional studies under Crohn Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 45. This study's planned 21 months is below that.
Counting every sponsor, half of 82 studies reached it within 34 months; a quarter within 23 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Shattuck Labs, Inc.