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NCT06567470CompletedPhase 2

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.

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
96 (actual)
First submitted
16 Aug 2024
Start date
29 Jul 2025
Primary completion date
2 Jul 2026
Lead sponsor
Citryll BV
NCT number
NCT06567470
EU CT number
2024-517356-35-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 96
  • From 29 Jul 2025 to the primary completion date, 2 Jul 2026
  • 25 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
  • Current inflammatory joint disease other than RA (Sjogren with active disease is included).

Other

  • Contra-indication for CIT-013

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ziekenhuis Aan De Stroom
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AntwerpBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Sozialstiftung Bamberg
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BambergGermanyCompleted
Rheumatologische Schwerpunktpraxis
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Studienambulanz Rheumazentrum Ratingen GbR
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RatingenGermanyCompleted
University Of A Coruna
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A CorunaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario de la Princesa
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MadridSpainCompleted
Instituto De Investigacion Marques De Valdecilla
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SantanderSpainCompleted
Universidade De Santiago De Compostela
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Santiago De CompostelaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Amsterdam UMC Stichting
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AmsterdamNetherlandsCompleted
Frisius MC
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LeeuwardenNetherlandsCompleted
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsCompleted
Prof. Herbert Kellner
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MunichNetherlandsCompleted
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsCompleted
Maasstad Ziekenhuis Stichting
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RotterdamNetherlandsCompleted
Clinicmed Daniluk Nowak Sp. k.
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BialystokPolandActive, not recruiting
Centrum Medyczne All-Med Badania Kliniczne
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CracowPolandActive, not recruiting
Reumed Sp. z o.o.
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LublinPolandActive, not recruiting
Medyczne Centrum Hetmańska Piotr Leszczyński
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PoznanPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandActive, not recruiting
Wsd Medi Clinical Sp. z o.o.
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WarsawPolandActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.