SBT777101 for Hidradenitis Suppurativa

(Regulate-HS Trial)

Recruiting at 5 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

Trial Summary

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.

What data supports the effectiveness of the drug SBT777101 for treating Hidradenitis Suppurativa?

Research on similar treatments, like IL-17 inhibitors, shows promise in treating Hidradenitis Suppurativa, with drugs like brodalumab showing a 100% response rate in a small group of patients. This suggests that targeting similar pathways could be effective for SBT777101. ^{1 2 3 4 5}

How does the drug SBT777101 differ from other treatments for hidradenitis suppurativa?

The drug SBT777101 is unique because it may target specific pathways involved in hidradenitis suppurativa, potentially offering a new approach compared to existing treatments like IL-17 inhibitors, which have shown effectiveness in some patients but not all. This could be particularly beneficial for patients who do not respond well to current therapies. ^{1 6 7 8 9}

What is the purpose of this trial?

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.

Research Team

Joseph Arron, MD PhD

Principal Investigator

Sonoma Biotherapeutics, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa: New insights into disease mechanisms and an evolving treatment landscape. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Promising Therapeutic Targets in Hidradenitis Suppurativa: A Critical Evaluation of Mechanistic and Clinical Relevance. [2021]

4. England 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Medical management of hidradenitis suppurativa. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Hidradenitis Suppurativa: A Perspective on Genetic Factors Involved in the Disease. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Management of patients with hidradenitis suppurativa having underlying genetic variation: a systematic review and a call for precision medicine. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The genetic aspects of hidradenitis suppurativa. [2023]