An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: CND261

• Registration Number: NCT07052032
• Lead Sponsor: Candid Therapeutics

Brief Summary

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

Detailed Description

This is 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. The study consists of 2 parts: a dose-escalation part and an open-label expansion. Patients will be followed until Week 52.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-16
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Primary Completion: 2027-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CND261	CND261	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment-emergent adverse events through end of study	Baseline to Month 12
Changes from baseline in vital signs through end of study	Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval	Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval	Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval	Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study	Baseline to Month 12

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) concentration-time profiles for CND261	Baseline to Month 12
PK parameters for CND261: maximum concentration	Baseline to Month 12
PK parameters for CND261: time of maximum concentration	Baseline to Month 12
PK parameters for CND261: area under the concentration-time curve	Baseline to Month 12
PK parameters for CND261: clearance	Baseline to Month 12
PK parameters for CND261: volume of distribution	Baseline to Month 12
PK parameters for CND261: half-life	Baseline to Month 12

Trial Locations

Locations (1)

Candid Clinical Site; 🇲🇩 Chisinau, Moldova, Republic of