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

2025-523265-15-00 Protocol CND261-101 Human pharmacology (Phase I) - Other Ended

End 13 Apr 2026 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol CND261-101

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 47
Countries 1
Sites 2

Seropositive Rheumatoid Arthritis

Key facts

Sponsor
Candid Therapeutics Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20], Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
completed 13 Apr 2026
Decision date (initial)
2025-12-16
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2025-523265-15-00
ClinicalTrials.gov
NCT07052032

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Seropositive Rheumatoid Arthritis

VersionLevelCodeTermSystem organ class
23.1 LLT 10040107 Seropositive rheumatoid arthritis 10028395

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Candid Therapeutics Inc.

Sponsor organisation
Candid Therapeutics Inc.
Address
11622 El Camino Real Suite 150
City
San Diego
Postcode
92130-2051
Country
United States

Scientific contact point

Organisation
Candid Therapeutics Inc.
Contact name
Clinical Operations Team

Public contact point

Organisation
Candid Therapeutics Inc.
Contact name
Clinical Operations Team

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Romania Ended 9 2
Rest of world
Moldova, Republic of, New Zealand, Australia, Ukraine, Georgia
38

Investigational sites

Romania

2 sites · Ended
Spitalul Clinic Judetean De Urgenta Cluj
Ophthalmology Building, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
3rd Floor, Wards 1, 2, 3, 4, 5, 6 and 7, Intrarea Tudor Stefan 38-40, 011658, Bucharest

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-09-05 Romania No conclusion
2025-12-09
2025-12-16