2025-522189-60-00招募中2 期
Cityview: PET-Based Imaging to Evaluate the Distribution of Radiolabeled CIT-013 in Patients with Inflammatory Mediated Immune Disease
Citryll B.V.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年10月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The primary objective of this trial is to evaluate the distribution of radiolabeled CIT-013 in patients with IMIDs.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
- •(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).
- •(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.
- •(RA in remission specific) DAS28-CRP score ≤ 2.6 AND no Swollen Joints or Tender Joints at screening.
- •(HS specific) HS of ≥ 6 months duration (diagnosis based on medical records).
- •(HS specific) International Hidradenitis Suppurativa Severity Score System (IHS4) score of ≥ 7 AND at least 1 draining tunnel at screening.
- •Female (of non-childbearing potential) or male between 60-85 years of age (inclusive).
排除标准
- •Known history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
- •Active HBV, HCV, or HIV infection, as tested and confirmed during screening.
- •Evidence of active TB or being at high risk for TB, assessed according to local site procedures.
- •Male participants with a pregnant partner.
- •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.
- •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).
- •Any other multi-system autoimmune disease.
- •Any other condition which, in the Investigator’s opinion, will interfere with the trial.
- •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.
- •A recent (within 2 years) history of drug and/or alcohol abuse.
- •Prior treatment with CIT-
- •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.
结局指标
主要结局
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.
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.
次要结局
- Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings and ADAs.
- Pharmacokinetic (PK) levels throughout the trial, per cohort.
研究者
Maarten Kraan
Scientific
Citryll B.V.
研究点 (1)
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