EUCTR2016-000488-17-FR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 lupus 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 lupus characterised by:
- •SELENA-SLEDAI score = 6
- •Positive for Anti-nuclear antibody (ANA) antibody titer (=1:80)
- •Positive for anti-dsDNA antibody
- •With low levels (below the laboratory normal range) of C3 or C4 complement fractions OR a SELENA-SLEDAI score = 8
- •- Stable background therapy (dose and type) for at least 4 weeks before inclusion including oral corticotherapy at dose =7.5mg/day
- •- Both sexually active men and women must use highly effective methods of contraception during treatment including oral, or injectable contraceptives or intrauterine device or systems.
- •- 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 12
- •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 excipients
- •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
- •- Any clinical evidence of active chronic infection, HIV infection (positive serum antibodies against HIV1/2), active or chronic hepatitis B infection (positive for HBs-Ag in serum), active or chronic hepatitis C infection (positive for serum antibodies against HCV).
- •- Patient with clinical significant pleuritis with pleural effusion and/or pericarditis
- •- 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 inclusion
- •- Use of cyclosporine, interferon alpha and antimitotic agents in the past 4 weeks
- •- Use of any prohibited drug prior to the study participation as
- •Rituxan (rituximab )
- •- 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 <2 000/mm3, platelets <50 000/mm3, anemia with Hb=0.8 g/dl
- •- Elevated TSH and T4
- •- Existing cancer or a history of cancer treated within the past five years and in remission, 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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