EUCTR2016-000488-17-BG进行中（未招募）1 期
A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ILTOO PHARMA
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age = 18 years
- •- Male or female
- •- Having a confirmed diagnosis of SLE assessed by the presence of at
- •least 4 of the criteria of American College of Rheumatology (ACR) list
- •or of the Systemic Lupus International Collaborating Clinics (SLICC)
- •list at least at diagnosis.
- •- Having an active SLE characterised by:
- •SELENA-SLEDAI score = 6
- •Positive for Anti-nuclear antibody (ANA), (equivalent to titre =1:160)
- •positive either for anti-dsDNA-Abs OR for anti-Sm-Abs OR for anti-Ro-Abs OR for anti-Phospholipid-Abs (anti-Cardiolipin-Abs, anti-beta-2-Glycoprotein-Abs or lupus anticoagulant) OR for any combination of these antibodies
- •- Being on stable background therapy (dose and type) before inclusion
- •including any corticotherapy at dose lower than
- •30mg/day or 0.5mg/kg/day whichever is the lowest. Corticosteroids
- •and antimalarial drug should be stable for 1 month prior to
- •first dosing, immunosuppressant must be stable for 2 months prior to
- •- Normal thyroid function (evaluated by both TSH and T4) with or without treatment
- •- Using highly effective methods of contraception during treatment, if
- •sexually active men or women, including oral, or injectable
- •hormonal contraceptives or intrauterine device or systems, vasectomised partner, bilateral tubal occlusion or fully sexual
- •abstinence.
- •- Having freely provided informed consent to participate in the study
- •preceding any study procedure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •- A known contraindication to treatment with IL-2:
- •Hypersensitivity to the active substance or to any of its
- •Ongoing infection (requiring antibiotic treatment or fever=38°C)
- •at the time of inclusion
- •Blood oxygen saturation = 90% in resting position
- •A previous organ allograft
- •- Serious organ failure:
- •Renal functional impairment (glomerular Filtration Rate <60ml/min) OR (urinary protein = 2g/24h with normal
- •albuminemia)
- •Severe central nervous system manifestations
- •Heart failure of grade 3 or greater by the NYHA classification
- •Liver failure with transaminases more than 5 times the upper
- •limit of normal 60ml/min) OR (urinary protein = 2g/24h with normal albuminemia)
- •Severe central nervous system manifestations
- •Heart failure of grade 3 or greater by the NYHA classification
- •Liver failure with transaminases more than 5 times the upper
- •limit of normal
- •- Any clinical evidence of acute or chronic infection and/or HIV infection (positive serum antibodies against HIV1/2) and/or acute or chronic hepatitis B infection (positive for HBs-Ag in serum), acute or chronic hepatitis C infection (positive for serum HCV RNA ).
- •- Patient with clinical significant pleuritis with pleural effusion and/or
- •pericarditis
- •- Patient with mesenteric vasculitis or peritonitis or recent thrombosis (less than 3 months)
- •- Patient diagnosed with type 1 diabetes and/or Crohn’s disease
- •- Use of Benlysta (belimumab) in the past 4 weeks
- •- Use of or Rituximab in the past 24 weeks (6 months) prior to
- •- Use of cyclosporine, interferon alpha and antimitotic agents in the
- •past 4 weeks
- •- Use of any prohibited drug prior to the study participation as
- •described in section 9.3 and 9.4
- •- Vaccination with live attenuated virus in the last month
- •- Necessity for application of radiographic iodinated contrast media
- •during and 2 weeks after the completion of the treatment
- •- A white blood cell count <2000/ mm 3, platelets <50 000/ mm or
- •anemia with Hb=0.8 g/dl
- •- Elevated TSH and T4
- •- Existing cancer or a history of cancer treated within the past five
- •years, except cervical carcinoma in situ or basal cell carcinoma
- •- Veins in a poor state unsuitable for venepuncture
- •- Major surgery in the previous two months or anticipated during the
- •course of the Study period
- •- In women, pregnancy or lactation
- •- Psychiatric pathology or any other chronic illness or addiction that
- •might interfere with the ability to provide informed consent or to
- •comply with the requirements of the Protocol
- •- A patient under legal protection
- •- Having received any investigational product (small molecule or
- •biologic) or commercially available biologic agent within 4 weeks or
- •5 half-lives prior to signing of the ICF, whichever is greater
研究者
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