SBT777101 for Rheumatoid Arthritis

(Regulate-RA Trial)

Recruiting at 7 trial locations

Overseen By Sabrina Fox-Bosetti, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sonoma Biotherapeutics, Inc.

Must be taking: RA medications

Disqualifiers: Uncontrolled disease, Infections, Immunodeficiency, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

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 rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown.

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of their rheumatoid arthritis medications for at least 30 days before joining, so you won't need to stop taking your current medications.

How does the drug SBT777101 differ from other rheumatoid arthritis treatments?

The drug SBT777101 is unique because it may target different pathways or mechanisms compared to existing treatments like TNF inhibitors and other biologic agents. While specific details about SBT777101 are not provided, it could offer a novel approach for patients who do not respond well to current therapies. ^{1 2 3 4 5}

Who Is on the Research Team?

Joseph Arron, MD

Principal Investigator

Sonoma Biotherapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe rheumatoid arthritis who haven't responded well to existing treatments. Participants must have a BMI under 35, at least one joint suitable for biopsy, and evidence of inflammation. They should be on stable RA medication doses for 30 days and use effective contraception. Excluded are those with recent major surgery, uncontrolled diseases in various organs, frequent infections or active tuberculosis, and other inflammatory joint diseases.

Inclusion Criteria

My condition is currently moderate to severe.

I have not responded well to or couldn't tolerate existing RA treatments.

Body mass index (BMI) <35 kg/m^2, inclusive

Exclusion Criteria

I do not have uncontrolled heart, lung, kidney, liver, hormone, or stomach/intestine diseases.

I frequently get infections or currently have an infection.

I have or had an inflammatory joint disease that is not rheumatoid arthritis.

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

DLT Evaluation

Participants are monitored for dose-limiting toxicities and other adverse effects

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SBT777101

Trial Overview The study tests SBT777101's safety and effects as a single dose in humans with rheumatoid arthritis. It starts at low doses which increase once earlier levels are proven safe. This is the first time this treatment is being tested in people.

How Is the Trial Designed?

Group I: SBT777101 Dose 3 Experimental Treatment 1 Intervention

High dose SBT777101

Group II: SBT777101 Dose 2 Experimental Treatment 1 Intervention

Mid dose SBT777101

Group III: SBT777101 Dose 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

Rheumatoid arthritis (RA) treatment options have expanded significantly with the introduction of various biological agents, including TNF antagonists and other targeted therapies, which have shown efficacy in clinical trials.

Recent studies have explored new therapeutic targets, such as IL-6 and intracellular kinases, indicating ongoing advancements in RA treatment and the importance of understanding their mechanisms for safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging therapeutics for rheumatoid arthritis. Bingham, CO.[2008]

The introduction of TNF-α inhibitors has revolutionized the treatment of rheumatoid arthritis (RA), leading to the development of numerous new biologic agents that target different aspects of the immune system.

This review highlights both approved immune modulators and those in development, detailing their mechanisms of action and providing updates on their efficacy and safety, indicating a wide range of effective treatment options for RA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune modulation of rheumatoid arthritis. Pappas, DA., Geraldino-Pardilla, L., Bathon, JM.[2022]

Patients with rheumatoid arthritis (RA) who experience high disease activity at diagnosis or have a prolonged time from diagnosis to treatment are at greater risk of developing 'difficult-to-treat' (D2T) RA, highlighting the importance of early intervention.

Current literature indicates that while some clinical factors like obesity and psychological conditions may influence D2T RA, more research is needed to better define and manage this condition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Difficult-to-Treat Rheumatoid Arthritis: Definition, Clinical Presentation, and Management. Conran, C., Kolfenbach, J., Kuhn, K., et al.[2023]

Biological therapies for rheumatoid arthritis show significant variability in effectiveness and side effects among patients, highlighting the need for personalized medicine to tailor treatments to individual responses.

Current research aims to identify predictors of treatment response and adverse effects, which could lead to better matching of patients with therapies and potentially lower treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for personalised medicine for rheumatoid arthritis. Isaacs, JD., Ferraccioli, G.[2015]

Anti-TNF biologics have significantly changed the treatment landscape for rheumatoid arthritis, but many patients still experience inadequate disease control, highlighting the need for personalized treatment approaches.

A variety of new biologic disease-modifying anti-rheumatic drugs are becoming available, which may help tailor therapies to individual patients and improve overall management of rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-tumor necrosis factor-based biologic therapies for rheumatoid arthritis: present, future, and insights into pathogenesis. Paula, FS., Alves, JD.[2021]

Citations

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

Emerging therapeutics for rheumatoid arthritis. [2008]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Immune modulation of rheumatoid arthritis. [2022]

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

A Review of Difficult-to-Treat Rheumatoid Arthritis: Definition, Clinical Presentation, and Management. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The need for personalised medicine for rheumatoid arthritis. [2015]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Non-tumor necrosis factor-based biologic therapies for rheumatoid arthritis: present, future, and insights into pathogenesis. [2021]