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)

Phase 1

• Conditions: Systematic Lupus Erythematosus; MedDRA version: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-000488-17-BG
• Lead Sponsor: ILTOO PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-13
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- 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
- 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

Exclusion Criteria

- 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 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
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