RecruitingPhase 2NCT06567470

A Study With CIT-013 in RA Patients

A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.


Sponsor

Citryll BV

Enrollment

88 participants

Start Date

Jul 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an investigational drug called CIT-013 in people with rheumatoid arthritis (RA), a condition where the immune system attacks the joints, causing pain and swelling. The study wants to find out if CIT-013 can reduce joint inflammation in people who are already taking standard RA medications. **You may be eligible if:** - You are between 18 and 85 years old - You have been diagnosed with rheumatoid arthritis for at least 3 months - You have active disease with swollen and tender joints and elevated inflammation markers (CRP) - You have been on a stable dose of a conventional RA medication for at least 3 months **You may NOT be eligible if:** - Your RA is so severe that you need to start a biological drug (like a TNF inhibitor) right away - You have another active inflammatory joint disease (other than RA) - You have recently used a biological or targeted RA drug without an adequate washout period - There is a contraindication to CIT-013 for you specifically Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCIT-013 low dose

Subcutaneous injection

DRUGCIT-013 high dose

Subcutaneous injection

DRUGPlacebo

Subcutaneous injection

DRUGCIT-013 medium dose

CIT-013 medium dose


Locations(24)

BE-02

Antwerp, Belgium

Site BE-01

Leuven, Belgium

DE-04

Bamberg, Germany

DE-05

Berlin, Germany

DE-01

München, Germany

DE-02

München, Germany

DE-03

Ratingen, Germany

NL-02

Amsterdam, Netherlands

NL-05

Leeuwarden, Netherlands

NL-04

Leiden, Netherlands

NL-03

Nijmegen, Netherlands

NL-01

Rotterdam, Netherlands

PL-01

Bialystok, Poland

PL-07

Krakow, Poland

PL-03

Lublin, Poland

PL-02

Poznan, Poland

PL-05

Torun, Poland

PL-04

Warsaw, Poland

ES-02

A Coruña, Spain

ES-04

Barcelona, Spain

ES-05

Barcelona, Spain

ES-06

Madrid, Spain

ES-01

Santander, Spain

ES-03

Santiago de Compostela, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06567470


Related Trials