Phase 1 Rheumatoid Arthritis Trial, Recruiting NCT06201416 Sponsor: Sonoma Biotherapeutics, Inc. Condition: Rheumatoid Arthritis
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Phase 1 Rheumatoid Arthritis Trial, Recruiting

NCT06201416
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Your Body Mass Index (BMI) must be below 35 (a measure of body weight relative to height)
  • You have been diagnosed with rheumatoid arthritis (RA) that started in adulthood and is considered moderate to severe
  • Your RA is currently moderately to severely active
  • You have tried and not responded well enough to at least 2 specific types of RA medications called b/tsDMARDs (confirm with trial site)
  • You have 4 or more swollen joints at the time of screening
  • There is evidence of joint inflammation shown through a physical exam and/or an ultrasound scan
  • You have not responded well enough to, or could not tolerate, available RA treatments
  • You have been on a stable dose of your current RA medications for at least 30 days
  • You are using a highly effective form of birth control if applicable

Who may not be able to join:

  • You have had major surgery in the last 12 weeks, or are planning to have major surgery within 12 months of receiving the trial treatment
  • You have an uncontrolled serious condition affecting your heart, lungs, kidneys, liver, hormones, or digestive system
  • You have frequent infections or currently have an active infection
  • You have active tuberculosis (TB) or untreated latent (inactive/dormant) TB
  • You have a condition that weakens your immune system, either from birth or developed later in life
  • You have a history of, or currently have, any other inflammatory joint disease besides rheumatoid arthritis

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Sarah Baxter, MD, PhD, Sonoma Biotherapeutics, Inc.

Phone: 415-992-6245

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Sonoma Biotherapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
6 March 2024
Est. completion
1 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence, nature, and severity of adverse events [Safety and Tolerability]; Incidence and nature of dose-limiting toxicities (DLTs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov