NCT06917742 A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
| NCT ID | NCT06917742 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Capstan Therapeutics |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-04-09 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2025-04-09 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06917742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06917742 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06917742 currently recruiting?
Yes, NCT06917742 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT06917742 trial being conducted?
This trial is being conducted at Herston, Australia, Bayswater, Australia, Nedlands, Australia.
Who is sponsoring the NCT06917742 clinical trial?
NCT06917742 is sponsored by Capstan Therapeutics. The trial plans to enroll 64 participants.