Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Regulate-RA
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
1 other identifier
interventional
24
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 rheumatoid-arthritis
Started Mar 2024
Longer than P75 for phase_1 rheumatoid-arthritis
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2024
CompletedFirst Posted
Study publicly available on registry
January 11, 2024
CompletedStudy Start
First participant enrolled
March 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
April 20, 2026
April 1, 2026
2.7 years
January 1, 2024
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Day of treatment to end of follow-up period (48 weeks)
Incidence and nature of dose-limiting toxicities (DLTs)
Death, CRS, ICANS, vital organ toxicity, hematological toxicity
Day of treatment to end of DLT evaluation period (28 days)
Study Arms (3)
SBT777101 Dose 1
EXPERIMENTALLow dose SBT777101
SBT777101 Dose 2
EXPERIMENTALMid dose SBT777101
SBT777101 Dose 3
EXPERIMENTALHigh dose SBT777101
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) \<35 kg/m\^2, inclusive
- Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
- Moderate-to-severe active disease
- Clinical and/or ultrasound evidence of synovitis
- Prior inadequate response to or unable to tolerate available RA therapies
- Stable doses of RA medications for at least 30 days
- Use of highly effective methods of contraception
You may not qualify if:
- Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
- Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
- Recurrent infections or active infection
- Active or untreated latent tuberculosis
- Primary or secondary immunodeficiency
- History of or current inflammatory joint disease other than RA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Stanford Medical Center
Stanford, California, 94305, United States
University of Colorado
Aurora, Colorado, 80045, United States
Northwestern University
Chicago, Illinois, 60611, United States
Tufts University
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sarah Baxter, MD, PhD
Sonoma Biotherapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2024
First Posted
January 11, 2024
Study Start
March 6, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share