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A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)

RecruitingPhase 1Ages 18 Years - 65 YearsAllCapstan Therapeutics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • CPTX2309
  • CPTX2309
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Where

3 sites
Nucleus Network Brisbane
Herston, Australia
Veritus Research
Bayswater, Australia
Linear Clinical Research
Nedlands, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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