[89ZR]ZR-DFO-CIT-013 for Inflammatory mediated immune diseases

Inclusion criteria

• {"criterion_text":"- 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.\n- Willing and able to provide written, informed consent.\n- (RA specific) 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).\n- (active RA specific) Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) (DAS28-CRP) ≥ 4.2 AND ≥ 1 Swollen Joint AND ≥ 1 Tender Joint at screening.\n- (RA in remission specific) DAS28-CRP score ≤ 2.6 AND no Swollen Joints or Tender Joints at screening.\n- (HS specific) HS of ≥ 6 months duration (diagnosis based on medical records).\n- (HS specific) International Hidradenitis Suppurativa Severity Score System (IHS4) score of ≥ 7 AND at least 1 draining tunnel at screening.\n- Female (of non-childbearing potential) or male between 60-85 years of age (inclusive)."}

Exclusion criteria

• {"criterion_text":"- Known history of severe allergies, non-allergic drug reactions, or multiple drug allergies.\n- Active HBV, HCV, or HIV infection, as tested and confirmed during screening.\n- Evidence of active TB or being at high risk for TB, assessed according to local site procedures.\n- Male participants with a pregnant partner.\n- Known hypersensitivity to any of the ingredients (L-histidine, Histidine-HCl monohydrate, Sucrose, Polysorbate) of the IP, including the radioactive tracer, or to drugs of similar chemical structure or pharmacological profile.\n- Significant clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, at discretion of the Investigator (or designee).\n- Any other multi-system autoimmune disease.\n- Any other condition which, in the Investigator’s opinion, will interfere with the trial.\n- Female participants of childbearing potential (including females that are pregnant or breastfeeding). Follicle-stimulating hormone (FSH) levels < 50 IU/L are exclusionary, unless there is a confirmed other reason for non-childbearing potential (e.g., complete hysterectomy), at discretion of the Investigator.\n- A recent (within 2 years) history of drug and/or alcohol abuse.\n- Prior treatment with CIT-013.\n- Being an employee of the Investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee or the Investigator."}

Primary endpoints

• {"endpoint_text":"- This objective is measured by whole body PET-CT imaging 24 hours (D2) after IP administration. In addition to visual assessment, uptake of [89Zr]-DFO-CIT-013 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.","definition_or_measurement_approach":"Measured by whole body PET-CT imaging 24 hours (day 2) after IP administration; visual assessment plus quantitative measurement of uptake of [89Zr]-DFO-CIT-013 per organ/system; evaluation of distribution profiles per cohort and comparison between cohorts."}

Secondary endpoints

• {"endpoint_text":"- Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings and ADAs.\n- Pharmacokinetic (PK) levels throughout the trial, per cohort.","definition_or_measurement_approach":"TEAEs: frequency and severity collected throughout trial period including clinically relevant findings and anti-drug antibodies (ADAs). PK: measurement of pharmacokinetic levels per cohort across the trial."}

Methods

• Recruitment arrangements documented in 'K1_Recruitment arrangements' and related recruitment materials (country-specific: Netherlands).
• Website recruitment text (K2_NL-NL Recruitment material Website text NL-01 TC) — online channel targeting patients in the Netherlands.
• Link2Trials recruitment material (K2_NL-NL Recruitment material Link2Trials NL) — use of the Link2Trials online platform to reach potential participants.

Netherlands

Earliest CTIS Part Ii Submission Date

23-10-2025

Latest Decision Or Authorization Date

03-04-2026

Processing Time Days

162

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Citryll B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands