Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
NCT ID: NCT06201416
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2024-03-06
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SBT777101 Dose 1
Low dose SBT777101
SBT777101
Experimental treatment
SBT777101 Dose 2
Mid dose SBT777101
SBT777101
Experimental treatment
SBT777101 Dose 3
High dose SBT777101
SBT777101
Experimental treatment
Interventions
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SBT777101
Experimental treatment
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Sonoma Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Arron, MD
Role: STUDY_DIRECTOR
Sonoma Biotherapeutics, Inc.
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
UCSF Medical Center
San Francisco, California, United States
Stanford Medical Center
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Tufts University
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBT777101-01
Identifier Type: -
Identifier Source: org_study_id