Rheumatoid ArthritisPhase 2CitydreamNCT06567470
A Study With CIT-013 in RA Patients
A Phase 2 study testing CIT-013 low dose, CIT-013 high dose and CIT-013 medium dose in people with Rheumatoid Arthritis, run by Citryll BV at 20 sites in 5 countries.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CIT-013 low dose, CIT-013 high dose and CIT-013 medium dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 29 Jul 2025to 11 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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 week for etanercept;
- ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
Show all 10Show fewer
- ≥ 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.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Poland6 sites
PL-01
Bialystok
PL-07
Krakow
PL-03
Lublin
PL-02
Poznan
PL-05
Torun
PL-04
Warsaw
Spain6 sites
ES-02
A Coruña
ES-04
Barcelona
ES-05
Barcelona
ES-06
Madrid
ES-01
Santander
ES-03
Santiago de Compostela
About this study
Official title: 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- CIT-013 low dose, CIT-013 high dose, Placebo, CIT-013 medium dose
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIT-013 low doseDrug
Subcutaneous injection
CIT-013 high doseDrug
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
CIT-013 medium doseDrug
CIT-013 medium dose
| Study group | Role | What they receive |
|---|---|---|
| CIT-013 low dose | Experimental | 3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013 Receives: Drug: CIT-013 low dose |
| CIT-013 high dose | Experimental | 3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose Receives: Drug: CIT-013 high dose |
| Placebo | Placebo comparator | 3 SC injections with placebo and 3 SC injections with CIT-013 medium dose Receives: Drug: Placebo |
| CIT-013 medium dose | Experimental | 6 SC injections with CIT-013 medium dose Receives: Drug: CIT-013 medium dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in DAS28-CRP at week 6 compared to baseline
Efficacy of CIT-013
Measured: week 6
Secondary outcomes (2)
Incidence of TEAEs as assessed by CTCAE
Safety and tolerability of CIT-013
Measured: 12 weeks
Maximum Plasma Concentration of CIT-013 before doses
CIT-013 levels
Measured: 4, 6, 10 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start29 Jul 2025
- Primary completion2 Jul 2026
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Citryll BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maarten Kraan, Study director, Citryll BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567470
- Sponsor's protocol ID
- CITRYLL002
- Acronym
- Citydream
- Status last verified
- Nov 2025
- First submitted
- 16 Aug 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06567470
- Acronym / sponsor ID
- Citydream / CITRYLL002
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Citryll BVIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CIT-013 low dose | Experimental | Drug: CIT-013 low dose3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013 |
| CIT-013 high dose | Experimental | Drug: CIT-013 high dose3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose |
| Placebo | Placebo comparator | Drug: Placebo3 SC injections with placebo and 3 SC injections with CIT-013 medium dose |
| CIT-013 medium dose | Experimental | Drug: CIT-013 medium dose6 SC injections with CIT-013 medium dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
- Treated with ≥ 3 bDMARD or tsDMARD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIT-013 low doseSubcutaneous injection | Drug | CIT-013 low dose |
| CIT-013 high doseSubcutaneous injection | Drug | CIT-013 high dose |
| PlaceboSubcutaneous injection | Drug | Placebo |
| CIT-013 medium doseCIT-013 medium dose | Drug | CIT-013 medium dose |
Primary outcome
The change in DAS28-CRP at week 6 compared to baseline
Time frame: week 6
Efficacy of CIT-013
2 secondary outcomes
Incidence of TEAEs as assessed by CTCAE
Time frame: 12 weeks
Maximum Plasma Concentration of CIT-013 before doses
Time frame: 4, 6, 10 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Kraan study director
Citryll BV
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CIT-013 low dose, CIT-013 high dose and CIT-013 medium dose in people with Rheumatoid Arthritis, run by Citryll BV at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Poland, Spain, Germany, Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in DAS28-CRP at week 6 compared to baseline (time frame: week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.