A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)
- Conditions
- Systematic Lupus ErythematosusMedDRA version: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-000488-17-FR
- Lead Sponsor
- ILTOO PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- 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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method