An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis

Launched by CANDID THERAPEUTICS · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called CND261 to see if it is safe and helpful for people with seropositive rheumatoid arthritis (RA), a condition where the immune system attacks the joints causing pain and swelling. The study is currently looking for adults between 18 and 75 years old who have been diagnosed with RA that is moderate to severe and have not had enough improvement with their current treatments. Participants need to have a certain level of joint function (Class I to III) and be on stable treatments for their RA.

If you join this study, you can expect to receive CND261 while doctors watch closely to see how your body responds and to check for any side effects. The study is open to all genders but has some important rules about who can join, such as not allowing people with active infections, other serious health issues, recent major surgery, or who are pregnant or breastfeeding. The goal is to understand whether CND261 can be a safe and effective option to help people manage their RA symptoms better.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 to 75 years old
• • 2. Diagnosis of adult-onset RA
• • 3. Class I-III RA
• • 4. Moderately to severely active RA
• • 5. Inadequate treatment response as defined in the protocol
• • 6. Stable use of any concomitant therapies
• Exclusion Criteria:
• • 1. Inadequate clinical laboratory parameters at Screening
• • 2. Active infection
• • 3. Receipt of or inability to discontinue any excluded therapies
• • 4. Receipt of live vaccine within 4 weeks
• • 5. Presence of any concomitant autoimmune disease
• • 6. Active or known history of catastrophic anti-phospholipid syndrome
• • 7. APS or thrombotic event not adequately controlled by anticoagulation therapy
• • 8. History of progressive multifocal leukoencephalopathy
• • 9. Central nervous system disease
• • 10. Presence of 1 or more significant concurrent medical conditions
• • 11. Have a diagnosis or history of malignant disease within 5 years
• • 12. Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair ability to receive planned treatment or to understand informed consent
• • 13. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
• • 14. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
• • 15. Women who are pregnant or breastfeeding
• • 16. Patients who do not agree to the use of highly effective contraception as defined by the protocol