PET-Based Imaging of Radiolabeled CIT-013
ConditionRA
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-85
SponsorCitryll BV
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
[89Zr]Zr-CIT
Drugradiolabelled CIT-013
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: [89Zr]Zr-CIT-013Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
24 hoursSecondary 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.
Time frame
Day 29 Source ClinicalTrials.gov