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Not yet recruitingNCT07934017Updated Nov 12, 2026

A Study of SL-325 in Participants With Hidradenitis Suppurativa

A Phase 2 interventional study of SL-325 and Placebo in Hidradenitis Suppurativa (HS), sponsored by Shattuck Labs, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Shattuck Labs, Inc. · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with Hidradenitis Suppurativa.

The study consists of a screening period of up to 5 weeks, a 16-week primary treatment period, 36-week extension period, and a follow-up period of up to 12 weeks.

02

Conditions studied

  • Hidradenitis Suppurativa (HS)

Keywords

  • Hidradenitis Suppurativa
03

In context

Hidradenitis Suppurativa

285 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's planned enrollment of 150 is above the median of 45 across 200 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Shattuck Labs, Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A clinical diagnosis of HS at Screening as assessed by the Investigator.
  • Signs and symptoms of HS for ≥6 months prior to Screening.
  • ≥5 total AN count.
  • HS lesions present in ≥2 distinct anatomical areas.
  • ≥1 anatomic area of HS involvement characterized as Hurley Stage II or III.
  • Draining tunnel count of ≤20.
  • Inadequate response or recurrence of disease activity after an appropriate course of systemic antibiotics for the treatment of HS OR intolerance or to systemic antibiotics for the treatment of HS.

Exclusion criteria

Exclusion Criteria:

  • Evidence of other active skin disease or condition that could, in the Investigator's opinion, interfere with the evaluation of HS.
  • Prior exposure to any anti-DR3 or anti-TL1A agent or agent with an anti-DR3 or anti-TL1A component.
  • Active tuberculosis (TB) or inadequately treated latent tuberculosis infection (LTBI)
Terms in these criteria, in plain language(1)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    SL-325 high dose

    Drug: SL-325

  • Experimental
    SL-325 low dose

    Drug: SL-325

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSL-325

    SL-325 administered intravenously

  • DrugPlacebo

    Placebo administered intravenously

06

What researchers measure

Primary outcomes

  1. Proportion of participants achieving HiSCR50

    The proportion of participants achieving HiSCR50, defined as a ≥50% reduction in total AN count, with no increase in abscess count and no increase in draining tunnel count, relative to baseline.

    Time frame: Week 16

Secondary outcomes

  1. Proportion of participants achieving HiSCR75

    The proportion of participants achieving HiSCR75, defined as a ≥75% reduction in the total AN count, with no increase in abscess count and no increase in draining tunnel count, relative to baseline.

    Time frame: Week 16

  2. Incidence and severity of treatment-emergent adverse events

    Incidence and severity of treatment-emergent adverse events (TEAEs)

    Time frame: Week 16

  3. 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 16

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Feb 2028, 13 months later.

Of 44 industry-sponsored phase 2 interventional studies under Hidradenitis Suppurativa, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 20. This study's planned 13 months is below that.

Counting every sponsor, half of 54 studies reached it within 15 months; a quarter within 11 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Jan 2027
Primary completionEst.
Feb 2028
CompletionEst.
Dec 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07934017
Lead sponsor
Shattuck Labs, Inc.
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Jan 2027 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Shattuck Medical Director
Contact
clinicaltrials@shattucklabs.com
919-864-2700

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: 3-(2-(4-quinolin-3-yl)benzyl-1-oxoisoindolin-6-yl)-N-hydroxy-acrylamide

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Shattuck Labs, Inc.

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