SBT777101 for Hidradenitis Suppurativa

(Regulate-HS Trial)

Recruiting at 6 trial locations

Overseen By Jason Do

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sonoma Biotherapeutics, Inc.

Must be taking: Systemic therapy, Biologic drug

Disqualifiers: Autoimmune disease, Complex HS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effects of a new treatment, SBT777101, for individuals with hidradenitis suppurativa, a skin condition that causes painful lumps and sores. The study will test different dose levels to observe the body's response. Suitable candidates include those with moderate to severe cases who have had the condition for a while and have not found sufficient relief from other treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that your medications for hidradenitis suppurativa be stable for at least 5 weeks before starting the study drug. This means you should not change your current medications during that time.

Is there any evidence suggesting that SBT777101 is likely to be safe for humans?

Research is testing SBT777101 for safety in people with hidradenitis suppurativa, a skin condition. Earlier studies with rheumatoid arthritis patients showed positive safety results for SBT777101, indicating that patients handled the treatment without major issues.

In the current trial, researchers administer SBT777101 in varying doses, starting low and gradually increasing, but only if the lower doses prove safe. This approach helps ensure participant safety. As one of the first human tests of SBT777101, the main goal is to confirm its safety before advancing to more detailed studies.

Prospective participants should know that safety is being carefully monitored. However, as this is an early-stage study, not all potential side effects may be known yet. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hidradenitis suppurativa?

Unlike the standard treatments for Hidradenitis Suppurativa, which typically include antibiotics, anti-inflammatory drugs, or biologics like adalimumab, SBT777101 offers a novel approach. Researchers are excited about SBT777101 because it introduces a new active ingredient specifically designed to target the underlying processes of the disease. This treatment is available in varying doses, allowing for tailored therapy that could optimize effectiveness and minimize side effects. The potential of SBT777101 to provide a more precise and personalized treatment option is what makes it stand out from existing therapies.

What evidence suggests that SBT777101 might be an effective treatment for hidradenitis suppurativa?

Research has shown that treatments targeting IL-17, a protein involved in inflammation, can help with hidradenitis suppurativa (HS). Some existing IL-17 blockers, such as secukinumab and brodalumab, have produced promising results, with about 57.1% of patients responding well. SBT777101, a new treatment being tested in this trial for HS, is thought to work similarly by targeting this inflammation process. Although direct data on SBT777101 remains limited, its development is based on the success of other IL-17 blockers. The goal is for SBT777101 to reduce inflammation and symptoms in people with HS. ^{3 6 7 8 9}

Who Is on the Research Team?

Joseph Arron, MD PhD

Principal Investigator

Sonoma Biotherapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with Hidradenitis Suppurativa, a skin condition characterized by painful lumps under the skin. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

Must agree to use highly effective method of contraception for at least 1 year post SBT777101 administration

Body mass index (BMI) must be ≤50 kg/m2

Total draining tunnel (dT) count must be ≤20

Exclusion Criteria

I currently have an infection or often get infections.

I have a condition that weakens my immune system.

My condition is a severe form of hidradenitis suppurativa.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of SBT777101 to evaluate safety and effects

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after receiving the single dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SBT777101

Trial Overview The study is testing SBT777101, a new treatment given as a single dose to people with Hidradenitis Suppurativa. The trial will start at lower doses and increase only if those are shown to be safe.

How Is the Trial Designed?

Group I: SBT777101 Dose Level 3 Experimental Treatment 1 Intervention

High dose SBT777101

Group II: SBT777101 Dose Level 2 Experimental Treatment 1 Intervention

Mid dose SBT777101

Group III: SBT777101 Dose Level 1 Experimental Treatment 1 Intervention

Low dose SBT777101

Who Is Running the Clinical Trial?

Sonoma Biotherapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

90+

Published Research Related to This Trial

A systematic review of 9 clinical trials involving various treatments for hidradenitis suppurativa highlighted the lack of a universally effective therapy, indicating the complexity of managing this chronic inflammatory disease.

The review included therapies such as antibiotics, hormonal treatments, and biologics, but emphasized the challenges in comparing their effectiveness due to variability in treatment outcomes and the need for better validation of outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical management of hidradenitis suppurativa. Orenstein, LA., Micheletti, RG.[2018]

Patients with hidradenitis suppurativa (HS) who have genetic variants may not be adequately represented in current treatment guidelines, which primarily focus on classic HS cases.

These genetically driven forms of HS may respond poorly to standard therapies, highlighting the need for updated guidelines that consider the unique needs of this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of patients with hidradenitis suppurativa having underlying genetic variation: a systematic review and a call for precision medicine. Mintoff, D., Pace, NP., Borg, I.[2023]

IL-17 inhibitors, particularly secukinumab and brodalumab, show promising efficacy in treating hidradenitis suppurativa (HS), with response rates of 57.1% and 100% respectively among 128 patients studied.

These treatments can be effective for patients who do not respond to other therapies, highlighting the need for standardized outcome measures to improve future research and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. Kashetsky, N., Mufti, A., Alabdulrazzaq, S., et al.[2022]

A study using whole transcriptome profiling identified key regulatory pathways involved in hidradenitis suppurativa (HS), including glucocorticoid receptor and IL17A signaling, which may drive the disease's mechanisms.

Sixteen specific genes were found to characterize HS at a molecular level, and proteins associated with immune response were strongly expressed in affected skin areas, suggesting that HS involves significant immune-related processes affecting skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa. Zouboulis, CC., Nogueira da Costa, A., Makrantonaki, E., et al.[2021]

Hidradenitis Suppurativa (HS) is a complex skin disease influenced by various factors, including genetic, immunologic, and environmental elements, with three recognized forms: sporadic, familial, and syndromic.

Recent genetic studies, including Sanger sequencing and Next Generation Sequencing, have identified several genetic variants linked to HS, which may help in understanding the disease's causes and developing new treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis Suppurativa: A Perspective on Genetic Factors Involved in the Disease. Moltrasio, C., Tricarico, PM., Romagnuolo, M., et al.[2022]

Hidradenitis suppurativa (HS) is a chronic inflammatory disease affecting 1-2% of the population, characterized by painful nodules and abscesses, primarily in areas like the armpits and groin, leading to significant tissue damage over time.

Currently, adalimumab is the only FDA-approved biologic for HS, showing a clinical response in about 50% of patients, while new treatments targeting IL-17 and JAK/STAT pathways are being explored in clinical trials, highlighting the urgent need for better diagnostic and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa: New insights into disease mechanisms and an evolving treatment landscape. Krueger, JG., Frew, J., Jemec, GBE., et al.[2023]

A systematic review of 5310 articles led to the analysis of 171 studies, resulting in evidence-based recommendations for managing hidradenitis suppurativa (HS), emphasizing the use of topical clindamycin for mild cases and biologic therapy like adalimumab for more severe cases after conventional treatments fail.

The review established that local surgical excision is recommended for mild-to-moderate HS, while more extensive disease may require wide excision, highlighting the need for tailored treatment approaches based on disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. Zouboulis, CC., Bechara, FG., Dickinson-Blok, JL., et al.[2020]

Hidradenitis suppurativa (HS) has a significant genetic component, with about one-third of cases having a positive family history, particularly in those with early onset, indicating a strong heritability factor.

The disease is classified into various categories based on genetic factors, with familial HS showing autosomal dominant inheritance and recent discoveries linking multiple gene mutations to its pathogenesis, suggesting HS is a polygenic, multifactorial autoinflammatory condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The genetic aspects of hidradenitis suppurativa. Balić, A., Marinović, B., Bukvić Mokos, Z.[2023]

This systematic review highlights new therapeutic targets for hidradenitis suppurativa (HS), focusing on cytokines like IL-1, IL-23, and IL-17, as well as Jak inhibition, based on observational data and ongoing placebo-controlled studies.

There are concerns about high placebo response rates and the reliability of clinical scoring in some studies, indicating a need for more detailed inflammatory profiling to better understand HS and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Promising Therapeutic Targets in Hidradenitis Suppurativa: A Critical Evaluation of Mechanistic and Clinical Relevance. Frew, JW., Marzano, AV., Wolk, K., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-1-hidradenitis-suppurativa-4-2024-3b60b

SBT777101 for Hidradenitis Suppurativa (Regulate-HS Trial) IL-17 inhibitors, particularly secukinumab and brodalumab, show promising efficacy in treating hidradenitis suppurativa (HS), with response rates of 57.1% and ...

2. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/sbt-777101-sonoma-biotherapeutics-hidradenitis-suppurativa-likelihood-of-approval/

SBT-777101 by Sonoma Biotherapeutics for Hidradenitis ... SBT-777101 is under clinical development by Sonoma Biotherapeutics and currently in Phase I for Hidradenitis Suppurativa.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06547

Study of Single Doses of SBT777101 in Subjects With ... This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa.

4. globenewswire.com globenewswire.com/news-release/2025/10/23/3172338/0/en/Hidradenitis-Suppurativa-Clinical-Trial-Analysis-Key-Insights-into-Rich-Pipeline-Featuring-24-Companies-and-26-Therapies-DelveInsight.html

Hidradenitis Suppurativa Clinical Trial Analysis: Key The study will evaluate tibulizumab over a 28-week period, comprising a 16-week primary efficacy assessment and a 12-week safety follow-up, with ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=e059157e-8056-4828-bd0e-5ec39a1a7306

SBT-77-7101 / Sonoma Biotherap Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa ... Data from Novel Treg Cell Therapy at Symposium on Hidradenitis Suppurativa ...

6. sonomabio.com sonomabio.com/2025/10/sonoma-biotherapeutics-announces-positive-interim-safety-and-efficacy-data-from-phase-1-regulate-ra-study-of-sbt-77-7101-in-refractory-rheumatoid-arthritis/

Sonoma Biotherapeutics SBT-77-7101 is currently being evaluated in Phase 1 clinical trials for patients with rheumatoid arthritis (RA) and hidradenitis suppurativa.

7. ctv.veeva.com ctv.veeva.com/study/study-of-single-doses-of-sbt777101-in-subjects-with-hidradenitis-suppurativa

Study of Single Doses of SBT777101 in Subjects With ... This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa.

8. sigma.larvol.com sigma.larvol.com/ott.php?e1=948396&sourcepg=TZ

Online Trial Tracker Oct 2025 - Oct 2025 : Interim safety data for rheumatoid arthritis ... NCT06361836: Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/condition/941/hidradenitis-suppurativa

Hidradenitis Suppurativa Clinical Research Trials Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa. The study evaluates the safety and effects of a novel regulatory CARTreg cell ...