Actively Recruiting
PET-Based Imaging of Radiolabeled CIT-013
Led by Citryll BV · Updated on 2026-01-30
12
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PET-Based Imaging of Radiolabeled CIT-013
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female (of non-childbearing potential) or male between 60 and 85 years of age (both inclusive)
- Male participants with female partners of child-bearing potential must use adequate contraception and avoid sperm donation during the trial and for 6 months after investigational product administration
- Willing and able to provide written, informed consent
You will not qualify if you...
- Diagnosed with rheumatoid arthritis according to the 2010 ACR and EULAR classification criteria 6 months or more before screening
- Participants in Cohort A (active RA) must have a Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) of 4.2 or higher with at least 1 swollen joint and 1 tender joint before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NL-01
Nijmegen, Netherlands
Actively Recruiting
Research Team
L
Leonie Middelink
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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