A Study With CIT-013 in RA Patients (Citydream)

May 20, 2026 updated by: Citryll BV

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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        • Withdrawn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        • Withdrawn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        • Withdrawn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        • Withdrawn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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CIT-013 medium dose
6 SC injections with CIT-013 medium dose
Drug: CIT-013 medium dose
CIT-013 medium dose
Experimental: CIT-013 low dose
3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013
Drug: CIT-013 low dose
Subcutaneous injection
Experimental: CIT-013 high dose
3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose
Drug: CIT-013 high dose
Subcutaneous injection
Placebo Comparator: Placebo
3 SC injections with placebo and 3 SC injections with CIT-013 medium dose
Drug: Placebo
Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in DAS28-CRP at week 6 compared to baseline
Time Frame: week 6
Efficacy of CIT-013
week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of TEAEs as assessed by CTCAE
Time Frame: 12 weeks
Safety and tolerability of CIT-013
12 weeks
Maximum Plasma Concentration of CIT-013 before doses
Time Frame: 4, 6, 10 and 12 weeks
CIT-013 levels
4, 6, 10 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Citryll BV

Investigators

  • Study Director: Maarten Kraan, Citryll BV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CITRYLL002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe