RecruitingPhase 1NCT07052032

An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of CND261 in Patients With Seropositive Rheumatoid Arthritis

Sponsor

Candid Therapeutics

Enrollment

47 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

to 75 years old
Diagnosis of adult-onset RA
Class I-III RA
Moderately to severely active RA
Inadequate treatment response as defined in the protocol
Stable use of any concomitant therapies

Exclusion Criteria16

Inadequate clinical laboratory parameters at Screening
Active infection
Receipt of or inability to discontinue any excluded therapies
Receipt of live vaccine within 4 weeks
Presence of any concomitant autoimmune disease
Active or known history of catastrophic anti-phospholipid syndrome
APS or thrombotic event not adequately controlled by anticoagulation therapy
History of progressive multifocal leukoencephalopathy
Central nervous system disease
Presence of 1 or more significant concurrent medical conditions
Have a diagnosis or history of malignant disease within 5 years
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
History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
Women who are pregnant or breastfeeding
Patients who do not agree to the use of highly effective contraception as defined by the protocol