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: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-000488-17-AT
- Lead Sponsor
- ILTOO PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
- 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)
AND
> 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 inclusion.
- Normal thyroid function (evaluated by both TSH and T4) with or without treatment
- Normal thyroid function (evaluated by both TSH and T4) with or without treatment
- Using highly effective methods of contraception during the duration of the study, including oral, or injectable hormonal contraceptives or intrauterine device or systems, vasectomised partner, bilateral tubal occlusion, combined with condom
- 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 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
- 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 disease 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), and/or 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 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 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
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