RAPhase 2CityviewNCT07147959
PET-Based Imaging of Radiolabeled CIT-013
A Phase 2 study testing [89Zr]Zr-CIT in people with RA, run by Citryll BV at 1 site in Netherlands.
Trial summary
Inflammatory mediated immune diseases (IMIDs), such as rheumatoid arthritis (RA) and hidradenitis suppurativa (HS), are characterized by chronic inflammation resulting from an aberrant immune response. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- RA
- What is being tested?
- [89Zr]Zr-CIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jan 2026to 15 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female (of non-childbearing potential) or male between 60-85 years of age (both inclusive).
- For male participants with female partners of child-bearing potential, an adequate form of contraception must be adhered to, and men must refrain from donating sperm, prior to entry into the trial and for a further 6 months after IP administration.
- Willing and able to provide written, informed consent.
Who cannot join
- Diagnosed with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 6 months prior to screening (diagnosis based on medical records).
- Participants in Cohort A (active RA) must furthermore meet the following criteria:
- Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) (DAS28-CRP) ≥ 4.2 AND ≥ 1 Swollen Joint AND ≥ 1 Tender Joint prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET-Based Imaging to Evaluate the Distribution of Radiolabeled CIT-013 in Patients With Inflammatory Mediated Immune Disease
Inflammatory mediated immune diseases (IMIDs), such as rheumatoid arthritis (RA) and hidradenitis suppurativa (HS), are characterized by chronic inflammation resulting from an aberrant immune response. Recent studies have identified neutrophil extracellular traps (NETs) as key contributors to the pathology of these diseases. CIT-013 is a novel humanized monoclonal antibody designed to inhibit NET release and enhance phagocytosis, offering a new potential therapeutic strategy for RA and HS. Previous clinical trials have demonstrated that CIT-013 is well tolerated in both healthy volunteers and patients with RA, with evidence of reduced NET formation and positive effects in active RA cases. Since NET-related inflammation primarily occurs in local tissues, understanding CIT-013's distribution beyond blood measurements is crucial for evaluating its therapeutic potential. This trial therefore uses radiolabeled CIT-013 and Positron Emission Tomography-Computed Tomography (PET-CT) imaging, along with lymph node biopsies, to evaluate the distribution of CIT-013 and target engagement in patients with IMIDs.
- Conditions
- RA
- Being tested
- [89Zr]Zr-CIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[89Zr]Zr-CITDrug
radiolabelled CIT-013
| Study group | Role | What they receive |
|---|---|---|
| [89Zr]Zr-CIT-013 | Experimental | Not described Receives: Drug: [89Zr]Zr-CIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of radiolabeled CIT-013 in patients with IMIDs
Whole body PET-CT imaging 24 hours (D2) after IP administration. In addition to visual assessment, uptake of [89Zr]-DFO-CIT013 will be quantified per organ(-system). In vivo distribution profiles will be evaluated per cohort to determine ranges of uptake per organ(-system) and between cohorts to compare uptake in different IMIDs
Measured: 24 hours
Secondary outcomes (1)
safety and tolerability of CIT-013 in patients with IMIDs.
Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings and ADAs.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start15 Jan 2026
- Primary completion15 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Citryll BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147959
- Sponsor's protocol ID
- CITRYLL004
- Acronym
- Cityview
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- PET-Based Imaging to Evaluate the Distribution of Radiolabeled CIT-013 in Patients With Inflammatory Mediated Immune Disease
- ClinicalTrials.gov ID
- NCT07147959
- Acronym / sponsor ID
- Cityview / CITRYLL004
- Conditions
- RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Citryll BVIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 29 Aug 2025 (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.
Inflammatory mediated immune diseases (IMIDs), such as rheumatoid arthritis (RA) and hidradenitis suppurativa (HS), are characterized by chronic inflammation resulting from an aberrant immune response. Recent studies have identified neutrophil extracellular traps (NETs) as key contributors to the pathology of these diseases. CIT-013 is a novel humanized monoclonal antibody designed to inhibit NET release and enhance phagocytosis, offering a new potential therapeutic strategy for RA and HS. Previous clinical trials have demonstrated that CIT-013 is well tolerated in both healthy volunteers and patients with RA, with evidence of reduced NET formation and positive effects in active RA cases. Since NET-related inflammation primarily occurs in local tissues, understanding CIT-013's distribution beyond blood measurements is crucial for evaluating its therapeutic potential. This trial therefore uses radiolabeled CIT-013 and Positron Emission Tomography-Computed Tomography (PET-CT) imaging, along with lymph node biopsies, to evaluate the distribution of CIT-013 and target engagement in patients with IMIDs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [89Zr]Zr-CIT-013 | Experimental | Drug: [89Zr]Zr-CIT |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female (of non-childbearing potential) or male between 60-85 years of age (both inclusive).
- For male participants with female partners of child-bearing potential, an adequate form of contraception must be adhered to, and men must refrain from donating sperm, prior to entry into the trial and for a further 6 months after IP administration.
- Willing and able to provide written, informed consent.
Key exclusion criteria (3 listed)
- Diagnosed with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 6 months prior to screening (diagnosis based on medical records).
- Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) (DAS28-CRP) ≥ 4.2 AND ≥ 1 Swollen Joint AND ≥ 1 Tender Joint prior to screening.
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 |
|---|---|---|
| [89Zr]Zr-CITradiolabelled CIT-013 | Drug | [89Zr]Zr-CIT-013 |
Primary outcome
Distribution of radiolabeled CIT-013 in patients with IMIDs
Time frame: 24 hours
Whole body PET-CT imaging 24 hours (D2) after IP administration. In addition to visual assessment, uptake of [89Zr]-DFO-CIT013 will be quantified per organ(-system). In vivo distribution profiles will be evaluated per cohort to determine ranges of uptake per organ(-system) and between cohorts to compare uptake in different IMIDs
1 secondary outcome
safety and tolerability of CIT-013 in patients with IMIDs.
Time frame: Day 29
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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [89Zr]Zr-CIT in people with RA, run by Citryll BV at 1 site in Netherlands.
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 3 inclusion and 3 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 1 site in Netherlands. 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. 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?
Distribution of radiolabeled CIT-013 in patients with IMIDs (time frame: 24 hours). 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.