Status:
NOT_YET_RECRUITING
PET-Based Imaging of Radiolabeled CIT-013
Lead Sponsor:
Citryll BV
Conditions:
RA
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07147959
Start Date
December 1 2025
End Date
December 1 2026
Last Update
November 25 2025
Active Locations (1)
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1
NL-01
Nijmegen, Netherlands