Actively Recruiting
A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
Led by Capstan Therapeutics · Updated on 2026-04-01
64
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
CONDITIONS
Official Title
A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants who are healthy as determined by medical history, physical exam, and lab tests during screening
- Willing and able to follow the study visit schedule and protocol requirements
- For rheumatoid arthritis participants: clinical diagnosis meeting 2010 ACR/EULAR criteria, presence of rheumatoid factor or ACPA above normal, and moderate active disease with at least 6 swollen and 6 tender joints or 3 joints with active synovitis on MRI
- For systemic lupus erythematosus participants: clinical diagnosis meeting 2019 EULAR/ACR criteria, positive ANA≥1:80, and presence of anti-dsDNA or anti-Smith autoantibodies above normal
You will not qualify if you...
- Evidence of organ dysfunction or significant abnormality in physical exam, vital signs, or lab tests beyond healthy norms
- Use of any investigational device or drug within 30 days or 5 half-lives prior to first CPTX2309 dose
- For rheumatoid arthritis participants: diagnosis of Felty's syndrome
- For systemic lupus erythematosus participants: active neuropsychiatric SLE within 6 months prior to screening (lupus headache allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nucleus Network Brisbane
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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