A Study With CIT-013 in RA Patients

Recruiting · NCT06567470 · Interventional (participants receive a specific treatment) · Lead sponsor: Citryll BV

View the official record on ClinicalTrials.gov →

Interventions studied

CIT-013 high doseCIT-013 low doseCIT-013 medium dosePlacebo

What this trial is about

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

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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 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.

Where it is running

24 locations listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →