NCT07147959 PET-Based Imaging of Radiolabeled CIT-013
| NCT ID | NCT07147959 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Citryll BV |
| Condition | RA |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2026-01-15 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07147959 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying RA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07147959 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07147959 currently recruiting?
Yes, NCT07147959 is actively recruiting participants. Contact the research team at lmiddelink@citryll.com for enrollment information.
Where is the NCT07147959 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT07147959 clinical trial?
NCT07147959 is sponsored by Citryll BV. The trial plans to enroll 12 participants.