An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis

NCT ID: NCT07052032

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2027-06-01

Brief Summary

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

Detailed Description

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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

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CND261

Group Type EXPERIMENTAL

CND261

Intervention Type BIOLOGICAL

CND261 will be dosed according to the assigned cohort

Interventions

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CND261

CND261 will be dosed according to the assigned cohort

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Candid Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Candid Clinical Site

Tbilisi, , Georgia

Site Status RECRUITING

Candid Clinical Site

Chisinau, , Moldova

Site Status RECRUITING

Candid Clinical Site

Auckland, , New Zealand

Site Status RECRUITING

Candid Clinical Site

Bucharest, , Romania

Site Status RECRUITING

Candid Clinical Site

Cluj-Napoca, , Romania

Site Status RECRUITING

Candid Clinical Site

Kyiv, , Ukraine

Site Status RECRUITING

Countries

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Georgia Moldova New Zealand Romania Ukraine

Central Contacts

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Clinical Operations

Role: CONTACT

858-247-0550

Facility Contacts

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Clinical Operations

Role: primary

8582470550

Clinical Operations

Role: primary

8582470550

Clinical Operations

Role: primary

8582470550

Clinical Operations

Role: primary

858-427-0550

Clinical Operations

Role: primary

858-247-0550

Clinical Operations

Role: primary

8584270550

Other Identifiers

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CND261-101

Identifier Type: -

Identifier Source: org_study_id

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