2024-517356-35-00招募中2 期
A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.
Citryll B.V.24 个研究点 分布在 5 个国家目标入组 77 人开始时间: 2025年7月11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
- 77
- 试验地点
- 24
- 主要终点
- The primary endpoint is the mean change in DAS28-CRP, from baseline to day 43, of CIT-013 the 50 mg CIT-013 and 100 mg CIT-013 arms pooled, compared to placebo.
研究概览
简要总结
The primary objective of this trial is to evaluate the efficacy of CIT-013 in patients with moderately active RA.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening (diagnosis based on medical records).
- •≥ 18 years of age.
- •Disease Activity Score ≥ 3.2 AND ≥ 3 Swollen Joints AND ≥ 3 Tender Joints, AND CRP/ESR ≥ upper limit of normal (ULN).
- •Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.
- •Agree to use adequate contraception during the trial for women of childbearing potential (WOCBP), and for 31 weeks after the last dose of IP, and must have a negative pregnancy test prior to entry into the trial. Whether female participants are of childbearing potential needs to be evaluated according to the criteria in Annex
- •Contraceptive Guidance.
- •Female participants must agree to refrain from donating ova during the trial and for at least 31 weeks after the last dose of IP.
- •Agree to use adequate contraception and refrain from donating sperm during the trial, and for 18 weeks after the last dose of IP, for male participants.
- •Body mass index is between 18 and 35 kg/m2, inclusive.
- •Willing and able to give written informed consent.
排除标准
- •Current inflammatory joint disease other than RA.
- •Use of bDMARD or tsDMARD prior to the first dose of IP, unless the washout period for bDMARDs or tsDMARD prior to the first dose of IP is at least: e) ≥ 2 weeks for etanercept; f) ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; g) ≥ 6 months for rituximab; h) ≥ 1 week of a targeted synthetic DMARD (tsDMARD).
- •Prior use of >3 biological DMARD (bDMARD) or tsDMARD treatments.
- •Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
- •History of malignancy with exception of non-melanoma skin cancer that has been excised and cured.
- •Active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus infection, as tested and confirmed during screening
- •Pregnant or lactating or planning to get pregnant during the duration of the trial.
- •Evidence of active tuberculosis (TB) or being at high risk for TB, assessed according to local site procedures.
- •History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis, as reported by participants.
- •High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
- •Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening or expected to be in need of this during the active part of the trial.
- •History of severe allergies, non-allergic drug reactions, or multiple drug allergies.
- •Known hypersensitivity to any of the inactive ingredients of the trial treatment.
- •Any other multi-system autoimmune disease.
- •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 condition which, in the Investigator’s opinion will interfere with completion of the trial.
- •Participant has taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this trial.
- •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
The primary endpoint is the mean change in DAS28-CRP, from baseline to day 43, of CIT-013 the 50 mg CIT-013 and 100 mg CIT-013 arms pooled, compared to placebo.
The primary endpoint is the mean change in DAS28-CRP, from baseline to day 43, of CIT-013 the 50 mg CIT-013 and 100 mg CIT-013 arms pooled, compared to placebo.
次要结局
- Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings.
- 2.1. Mean change in DAS28-CRP, from baseline to day 43, per arm of the originally assigned treatment. 2.2. Mean change in DAS28-CRP, from baseline to day 85, per arm of the originally assigned treatment.
- 3.1. Proportion of ACR20, ACR50, ACR707 responders, from baseline to day 43, per arm of the originally assigned treatment. 3.2. Proportion of ACR20, ACR50, ACR70 responders, from baseline to day 85, per arm of the originally assigned treatment.
- 3.3. Proportion of participants reaching low disease activity, defined as DAS28-CRP equal or less than 3.2, from baseline to day 43 and day 85, per arm of the originally assigned treatment. 3.4. Proportion of participants reaching disease remission, defined as DAS28-CRP less than 2.6, from baseline to day 43 and day 85, per arm of the originally assigned treatment.
- 3.5. Mean change in Simplified Disease Activity Index for RA (SDAI) and Clinical Disease Activity Index (CDAI) scores, from baseline to day 43, per arm of the originally assigned treatment. 3.6. Mean change in SDAI and CDAI scores, from baseline to day 85, per arm of the originally assigned treatment.
- 4.1. Mean change in Health Assessment Questionnaire Disability Index (HAQDI), from baseline to day 43, per arm of the originally assigned treatment. 4.2. Mean change in HAQDI scores, from baseline to day 85, per arm of the originally assigned treatment.
- 5.1. Pharmacokinetic (PK) levels throughout the trial, per arm of the originally assigned treatment.
研究者
Maarten Kraan
Scientific
Citryll B.V.
研究点 (24)
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