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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Citryll BV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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