Status:
RECRUITING
A Study With CIT-013 in RA Patients
Lead Sponsor:
Citryll BV
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are: Does CI...
Eligibility Criteria
Inclusion
- Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening
- Aged 18-85
- DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization
- Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.
Exclusion
- High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
- Contra-indication for CIT-013
- Current inflammatory joint disease other than RA (Sjogren with active disease is included).
- The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least:
- ≥ 1 week for etanercept;
- ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
- ≥ 6 months year for rituximab;
- ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment).
- Treated with ≥ 3 bDMARD or tsDMARD
- Injectable corticosteroids or treatment with \> 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
Key Trial Info
Start Date :
July 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06567470
Start Date
July 29 2025
End Date
July 1 2027
Last Update
December 1 2025
Active Locations (23)
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1
BE-02
Antwerp, Belgium
2
Site BE-01
Leuven, Belgium
3
DE-04
Bamberg, Germany
4
DE-05
Berlin, Germany