Crohn's DiseasePhase 2RECEPTIVE-CD1NCT07753850
A Study of SL-325 in Crohn's Disease Patients
A Phase 2 study testing SL-325 in people with Crohn's Disease, run by Shattuck Labs, Inc. at 20 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- SL-325
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 20 sitesUnited States
- Study dates
- 21 Oct 2026to Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Crohn's disease confirmed by endoscopy and histopathology ≥ 3 months prior to Screening
- Moderately to severely active CD as defined by CDAI of ≥ 220 and ≤ 450
- SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assessed by central review
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following Crohn's disease treatments: corticosteroids, immunomodulators, or an approved anti-tumor necrosis factor (TNF), anti-integrin, anti-interleukin (IL)-12/23, anti-interleukin (IL)-23p19, or Janus kinase inhibitor (JAK)
Who cannot join
- Diagnosis of UC, indeterminate colitis, or any other gastrointestinal condition that could undermine the diagnosis of CD
- CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- Presence or suspicion of any of the following CD complications: intra-abdominal or perianal abscess; symptomatic stricture or colonic stenosis not passable in ileocolonoscopy, fistula, except for perianal fistula; active toxic megacolon or fulminant colitis; short bowel syndrome
- Surgical bowel resection within 3 months before Screening, ≥ 3 bowel resections, or previous ileo-colonic resection of > 2 segments
- Diagnosis of primary sclerosing cholangitis
- Has a stoma, ileostomy, or colostomy.
Show all 9Show fewer
- Has prior or current gastrointestinal dysplasia, other than a completely removed low-grade dysplastic lesion.
- Has active tuberculosis (TB) or inadequately treated latent tuberculosis (LTBI)
- Prior exposure to any anti-DR3 or anti-TL1A agent or agent with an anti-DR3 or anti-TL1A component
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Not yet recruiting
Clinical Trial Site
Boston, Massachusetts, 02115
- Not yet recruiting
Clinical Trial Site
Cincinnati, Ohio, 45219
- Not yet recruiting
Clinical Trial Site
Columbus, Ohio, 43213
- Not yet recruiting
Clinical Trial Site
Glen Burnie, Maryland, 21061
- Not yet recruiting
Clinical Trial Site
Houma, Louisiana, 70360
- Not yet recruiting
Clinical Trial Site
Inverness, Florida, 34452
- Not yet recruiting
Clinical Trial Site
Kansas City, Kansas, 66160
- Recruiting
Clinical Trial Site
Kissimmee, Florida, 34741
- Not yet recruiting
Clinical Trial Site
Liberty, Missouri, 64068
- Not yet recruiting
Clinical Trial Site
Little Rock, Arkansas, 72205
- Not yet recruiting
Clinical Trial Site
Marrero, Louisiana, 70072
- Not yet recruiting
Clinical Trial Site
Maspeth, New York, 11378
- Not yet recruiting
Clinical Trial Site
Naples, Florida, 34102
- Not yet recruiting
Clinical Trial Site
Nashville, Tennessee, 37211
- Not yet recruiting
Clinical Trial Site
Orlando, Florida, 32803
- Not yet recruiting
Clinical Trial Site
Oxnard, California, 93030
- Not yet recruiting
Clinical Trial Site
St Louis, Missouri, 63110
- Not yet recruiting
Clinical Trial Site
Tampa, Florida, 33607
- Not yet recruiting
Clinical Trial Site
Temple City, California, 91780
- Not yet recruiting
Clinical Trial Site
West Hills, California, 91307
About this study
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
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.
- Conditions
- Crohn's Disease
- Being tested
- SL-325, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL-325Drug
SL-325 administered intravenously
PlaceboDrug
Placebo administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| SL-325 high dose | Experimental | Not described Receives: Drug: SL-325 |
| SL-325 mid dose | Experimental | Not described Receives: Drug: SL-325 |
| SL-325 low dose | Experimental | Not described Receives: Drug: SL-325 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (3)
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.
Measured: Week 12
Incidence and severity of treatment-emergent adverse events
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Week 12
Number of participants who discontinue study intervention due to an TEAE
Treatment-emergent adverse events (TEAEs) leading to discontinuation of study intervention
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start21 Oct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shattuck Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753850
- Sponsor's protocol ID
- SL-325-201
- Acronym
- RECEPTIVE-CD1
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07753850
- Acronym / sponsor ID
- RECEPTIVE-CD1 / SL-325-201
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Shattuck Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SL-325 high dose | Experimental | Drug: SL-325 |
| SL-325 mid dose | Experimental | Drug: SL-325 |
| SL-325 low dose | Experimental | Drug: SL-325 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of Crohn's disease confirmed by endoscopy and histopathology ≥ 3 months prior to Screening
- Moderately to severely active CD as defined by CDAI of ≥ 220 and ≤ 450
- SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assessed by central review
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following Crohn's disease treatments: corticosteroids, immunomodulators, or an approved anti-tumor necrosis factor (TNF), anti-integrin, anti-interleukin (IL)-12/23, anti-interleukin (IL)-23p19, or Janus kinase inhibitor (JAK)
Key exclusion criteria (9 listed)
- Diagnosis of UC, indeterminate colitis, or any other gastrointestinal condition that could undermine the diagnosis of CD
- CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- Presence or suspicion of any of the following CD complications: intra-abdominal or perianal abscess; symptomatic stricture or colonic stenosis not passable in ileocolonoscopy, fistula, except for perianal fistula; active toxic megacolon or fulminant colitis; short bowel syndrome
- Surgical bowel resection within 3 months before Screening, ≥ 3 bowel resections, or previous ileo-colonic resection of > 2 segments
- Diagnosis of primary sclerosing cholangitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SL-325SL-325 administered intravenously | Drug | SL-325 high dose, SL-325 low dose, SL-325 mid dose |
| PlaceboPlacebo administered intravenously | Drug | Placebo |
Primary outcome
Proportion of participants who achieve endoscopic response
Time frame: Week 12
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.
3 secondary outcomes
Proportion of participants who achieve clinical remission
Time frame: Week 12
Incidence and severity of treatment-emergent adverse events
Time frame: Week 12
Number of participants who discontinue study intervention due to an TEAE
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SL-325 in people with Crohn's Disease, run by Shattuck Labs, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shattuck Medical Director (919-864-2700, clinicaltrials@shattucklabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieve endoscopic response (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.