Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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.

A Study With CIT-013 in RA Patients (NCT06567470) is a Phase 2 interventional studying Rheumatoid Arthritis, sponsored by Citryll Bv. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Rheumatoid Arthritis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 88 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Rheumatoid Arthritis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 waiting period after previous treatment 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

CIT-013 low dose

Subcutaneous injection

DRUG

CIT-013 high dose

Subcutaneous injection

DRUG

Placebo

Subcutaneous injection

DRUG

CIT-013 medium dose

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06567470), the sponsor (Citryll Bv), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06567470 clinical trial studying?

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 ever… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06567470?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06567470?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06567470. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06567470. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.