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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07052032




Registration number
NCT07052032
Ethics application status
Date submitted
18/06/2025
Date registered
4/07/2025
Date last updated
27/08/2025

Titles & IDs
Public title
An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis
Scientific title
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
Secondary ID [1] 0 0
CND261-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CND261

Experimental: CND261 -


Treatment: Other: CND261
CND261 will be dosed according to the assigned cohort
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events through end of study
Timepoint [1] 0 0
Baseline to Month 12
Primary outcome [2] 0 0
Changes from baseline in vital signs through end of study
Timepoint [2] 0 0
Baseline to Month 12
Primary outcome [3] 0 0
Changes from baseline in ECG parameters through end of study: PR interval
Timepoint [3] 0 0
Baseline to Month 12
Primary outcome [4] 0 0
Changes from baseline in ECG parameters through end of study: QRS interval
Timepoint [4] 0 0
Baseline to Month 12
Primary outcome [5] 0 0
Changes from baseline in ECG parameters through end of study: QTcF interval
Timepoint [5] 0 0
Baseline to Month 12
Primary outcome [6] 0 0
Changes from baseline in safety laboratory assessments through end of study
Timepoint [6] 0 0
Baseline to Month 12
Secondary outcome [1] 0 0
Pharmacokinetic (PK) concentration-time profiles for CND261
Timepoint [1] 0 0
Baseline to Month 12
Secondary outcome [2] 0 0
PK parameters for CND261: maximum concentration
Timepoint [2] 0 0
Baseline to Month 12
Secondary outcome [3] 0 0
PK parameters for CND261: time of maximum concentration
Timepoint [3] 0 0
Baseline to Month 12
Secondary outcome [4] 0 0
PK parameters for CND261: area under the concentration-time curve
Timepoint [4] 0 0
Baseline to Month 12
Secondary outcome [5] 0 0
PK parameters for CND261: clearance
Timepoint [5] 0 0
Baseline to Month 12
Secondary outcome [6] 0 0
PK parameters for CND261: volume of distribution
Timepoint [6] 0 0
Baseline to Month 12
Secondary outcome [7] 0 0
PK parameters for CND261: half-life
Timepoint [7] 0 0
Baseline to Month 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
47
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Moldova
State/province [1] 0 0
Chisinau
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
Ukraine
State/province [3] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Candid Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
858-247-0550
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07052032