Lupus Eritematoso Sistémico (LES)
Conditions
Interventions
Product Code: IPP-201101
Pharmaceutical Form: Powder for injection*
Pharmaceutical form of the placebo: Powder for injection*
Route of administration of the placebo: Subcutaneous use
Sponsors
IMMUPHARMA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women ? 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female subjects of childbearing potential unless using a reliable contraception method and women who are pregnant or lactating 2. Treatment with dosage of prednisone equivalent > 80 mg /week (or > 72 mg of budesonide). 3. Treatment with intravenous pulse steroids within 4 weeks of Baseline. 4. Intravenous immunoglobulins (IgG), tacrolimus, or cyclosporine A within 3 months of Baseline. 5. Cyclophosphamide is not allowed within 12 months prior to study start and throughout the study 6. Treatment with biologic agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 12 months of study start. 7. Subjects having received B-cell depleting agents such as rituximab who have not yet normalized their B-cell count 8 Planned immunization with a live vaccine within 3 months prior to study treatment start and 3 months after treatment cessation 9. Previous or current history of malignancy (except subjects with a remote history (e.g greater than 5 years previously) of basal cell carcinoma, cervical carcinoma in situ). 10. Clinically significant abnormalities on chest X-Ray or electrocardiogram that are not related to SLE, as defined by the Principal Investigator 11. Any concomitant medical condition unrelated to SLE, which in the opinion of the Principal Investigator, may interfere with the safety or the evaluation of the study, including: • Chronic heart failure, previous myocardial infarction, chest pain within the last 3 months with changes in ECG and/or increased cardiac enzymes, • Ongoing active infection requiring antibiotic therapy, • Severe infection, such as hepatitis or pneumonia in the past three months. Ongoing active infection requiring antibiotic therapy, Less severe infections in the past 3 months are permitted at the discretion of the Principal Investigator • Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive • Chronic liver failure, • Uncontrolled diabetes mellitus, 12. Current drug and alcohol abuse as evidenced by medical history at Screening 13. Psychiatric, addictive, or any other disorder that compromises the ability to give truly informed written consent for participation in this study 14. Subjects with a history of severe allergic reactions to or hypersensitivity to any component of the drug or placebo 15. Has undergone or is undergoing treatment with another investigational drug within 6 months prior to entry in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of subcutaneous (sc) IPP201101 on the signs and symptoms of disease activity in subjects with active SLE, over a 12-week treatment period, compared to placebo ;Secondary Objective: • To investigate the effect of IPP-201101 on biological markers of disease activity • To investigate the effect of IPP201101 on the incidence of disease flares • To investigate the effect of IPP201101 on the occurrence of SLE-induced organ damage • To investigate the effect of IPP201101 on the health related quality of life (HRQoL) • To assess the durability of the therapeutic affects, over a 12-week follow up period • To identify the optimal dosing regimen of IPP201101, in order to determine the dosing regimen of Phase III clinical studies • To evaluate the safety and tolerability of sc IPP201101 in subjects with active SLE receiving standard therapy, compared to placebo ;Primary end point(s): Proportion of subjects achieving a combined clinical response at week 12. A combined clinical response is defined as: A reduction from baseline in the SLEDAI-2000 score of at least 4 points; no worsening in Physician’s Global Assessment (PGA) (with worsening defined as an increase in PGA of more than 0.30 points from baseline); no new British Isles Lupus Assessment Group (BILAG) A organ domain score and no more than 1 new BILAG B organ domain score from baseline. | — |
Countries
Bulgaria, Spain
Outcome results
None listed