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NCT Number: NCT07147959

PET-Based Imaging of Radiolabeled CIT-013

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.

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Key information

Conditions

RA

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NL-01

Nijmegen, Netherlands

Location status: Recruiting

Location contact

PI NL-01

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

[89Zr]Zr-CIT

Drug

radiolabelled CIT-013

Primary outcomes

  1. 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

Secondary outcomes

  1. safety and tolerability of CIT-013 in patients with IMIDs.

    Time frame: Day 29

    Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings and ADAs.

Study contacts

Contact information is provided by the study sponsor or research team.

Leonie Middelink

CONTACT

[email protected]

+31613328444

Sponsors and collaborators

Lead sponsor

Citryll BV

Industry

Registry information

Official study title

PET-Based Imaging to Evaluate the Distribution of Radiolabeled CIT-013 in Patients With Inflammatory Mediated Immune Disease

Acronym: Cityview

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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