Rheumatoid ArthritisPhase 1NCT07052032
An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis
A Phase 1 study testing CND261 in people with Rheumatoid Arthritis, run by Candid Therapeutics at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CND261
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jun 2025to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CND261
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CND261Biological
CND261 will be dosed according to the assigned cohort
| Study group | Role | What they receive |
|---|---|---|
| CND261 | Experimental | Not described Receives: Biological: CND261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events through end of study
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Measured: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study
Measured: Baseline to Month 12
Secondary outcomes (7)
Pharmacokinetic (PK) concentration-time profiles for CND261
Measured: Baseline to Month 12
PK parameters for CND261: maximum concentration
Measured: Baseline to Month 12
PK parameters for CND261: time of maximum concentration
Measured: Baseline to Month 12
PK parameters for CND261: area under the concentration-time curve
Measured: Baseline to Month 12
PK parameters for CND261: clearance
Measured: Baseline to Month 12
PK parameters for CND261: volume of distribution
Measured: Baseline to Month 12
PK parameters for CND261: half-life
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start16 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052032
- Sponsor's protocol ID
- CND261-101
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07052032
- Acronym / sponsor ID
- CND261-101
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Candid TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CND261 | Experimental | Biological: CND261 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CND261CND261 will be dosed according to the assigned cohort | Biological | CND261 |
Primary outcome
Incidence and severity of treatment-emergent adverse events through end of study
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study
Time frame: Baseline to Month 12
7 secondary outcomes
Pharmacokinetic (PK) concentration-time profiles for CND261
Time frame: Baseline to Month 12
PK parameters for CND261: maximum concentration
Time frame: Baseline to Month 12
PK parameters for CND261: time of maximum concentration
Time frame: Baseline to Month 12
PK parameters for CND261: area under the concentration-time curve
Time frame: Baseline to Month 12
PK parameters for CND261: clearance
Time frame: Baseline to Month 12
PK parameters for CND261: volume of distribution
Time frame: Baseline to Month 12
PK parameters for CND261: half-life
Time frame: Baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CND261 in people with Rheumatoid Arthritis, run by Candid Therapeutics at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Moldova, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events through end of study (time frame: Baseline to Month 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.