CPTX2309 for Rheumatoid Arthritis or Systemic Lupus Erythematosus
A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
Capstan Therapeutics · Industry
Who this trial is looking for
This trial is looking for healthy adults and adults with moderate to severe rheumatoid arthritis or systemic lupus erythematosus. Participants will receive a medication called CPTX2309 and help researchers learn about its safety and tolerability.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult aged 18 or older.
I am healthy or have moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
I can follow the study visit schedule.
I have a clinical diagnosis of rheumatoid arthritis or systemic lupus erythematosus.
I have been diagnosed with rheumatoid arthritis and have active disease.
I have been diagnosed with systemic lupus erythematosus and have specific autoantibodies.
You may not be able to join if
I have significant organ dysfunction.
I have been using any investigational drug or device within the last 30 days.
I have Felty's syndrome.
I have active neuropsychiatric SLE or symptoms in the past 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period.
* Participant is willing and able to adhere to the study visit schedule …
Inclusion Criteria:
* Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period.
* Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
RA Only:
* Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA
* Presence of rheumatoid factor or ACPA above the ULN
* Confirmation of at least moderate active disease at screening with the presence of at least 6 swollen and 6 tender joints at screening using the 68 (tender)/66 (swollen) joint count OR the presence of at least 3 joints with active synovitis via MRI assessment.
SLE Only:
* Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria for SLE
* Positive ANA\>=1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double standard DNA (dsDNA) or anti-Smith (Sm).
Exclusion Criteria:
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
* Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309.
RA Only:
\- Participants diagnosed with Felty's syndrome
SLE Only:
* Active neuropsychiatric SLE, as defined by the CNS portion of SLEDAI at Screening, or signs of symptoms of neuropsychiatric SLE within 6 months prior to Screening (lupus headache permissible)
* Note: Other protocol-defined inclusion/exclusion criteria apply
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