An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis

NCT07052032 | Active Not Recruiting Phase 1

• 1 other identifier: CND261-101
• Study Type: interventional
• Target: 47
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (1)

CND261

EXPERIMENTAL

Biological: CND261

Interventions

CND261 BIOLOGICAL

CND261 will be dosed according to the assigned cohort

CND261

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Candid Therapeutics: lead

Study Sites (3)

Candid Clinical Site

Tbilisi, Georgia

Location

Candid Clinical Site

Chisinau, Moldova

Location

Candid Clinical Site

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 4, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); MO (1); UA (1)