Clinical Trials in the Netherlands / NCT06567470
Recruiting Phase 2

A Study With CIT-013 in RA Patients

NCT06567470 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Phase
Phase 2
Started
2025-07-29
Last updated
2026-05-22

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

CIT-013 low dose →CIT-013 high dose →PlaceboCIT-013 medium dose →

CIT-013 low dose: Subcutaneous injection

CIT-013 high dose: Subcutaneous injection

Placebo: Subcutaneous injection

CIT-013 medium dose: CIT-013 medium dose

Study 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 CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA.

Participants will:

Take receive CIT-013 or placebo every other week for 6 weeks and 50 mg CIT-013 for 6 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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. ≥ 1 week for etanercept; 2. ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; 3. ≥ 6 months year for rituximab; 4. ≥ 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.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
BE-02 Antwerp Belgium Withdrawn
Site BE-01 Leuven Belgium Recruiting
DE-04 Bamberg Germany Recruiting
DE-05 Berlin Germany Recruiting
DE-01 München Germany Recruiting
DE-02 München Germany Recruiting
DE-03 Ratingen Germany Withdrawn
NL-02 Amsterdam Netherlands Withdrawn
NL-05 Leeuwarden Netherlands Recruiting
NL-04 Leiden Netherlands Withdrawn
NL-03 Nijmegen Netherlands Not Yet Recruiting
NL-01 Rotterdam Netherlands Recruiting
PL-01 Bialystok Poland Recruiting
PL-07 Krakow Poland Recruiting
PL-03 Lublin Poland Recruiting
PL-02 Poznan Poland Recruiting
PL-05 Torun Poland Recruiting
PL-04 Warsaw Poland Recruiting
ES-02 A Coruña Spain Recruiting
ES-04 Barcelona Spain Recruiting
ES-05 Barcelona Spain Recruiting
ES-06 Madrid Spain Recruiting
ES-01 Santander Spain Recruiting
ES-03 Santiago de Compostela Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06567470 on ClinicalTrials.gov ↗ ← All trials in the Netherlands