E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus (SLE) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10025135 |
E.1.2 | Term | Lupus erythematosus (incl subtypes) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men and women > 18 and < 70 years of age. 2. Women must be of non-childbearing potential, or if of childbearing potential (as determined by the investigator) must be using an effective method of birth control for 30 days prior to first administration of study drug and must agree to continue such precautions for the duration of the study. 3. Capable of understanding and complying with the protocol and be available for the duration of the study 4. Signed written informed consent form prior to initiation of any study related procedures 5. Established diagnosis of Systemic Lupus Erythematosus (SLE) defined by ACR Classification Revised Criteria (1997). The diagnosis is fulfilled provided that at least 4 criteria are met 6. A SLEDAI-2K score of at least 6 points and no "A" score on the BILAG scale 7. Positive test for antinuclear antibodies (ANA) 8. If using oral corticosteroids: • The weekly cumulative dose must not exceed 80mg of prednisone equivalent or 72 mg budesonide; • the weekly dose must be stable over the 4 weeks preceding study start 9. If using antimalarials, methotrexate, leflunomide, mycophenolate mofetil, or azathioprine: • the start-date must be at least 3 months prior to study start and • the daily dose must be stable over the 4 weeks preceding the study start 10. If not currently using corticosteroids, antimalarials, methotrexate, mycophenolate mofetyl, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to study start. For leflunomide, the stop date must be at least 8 weeks before study start, unless an adequate cholestyramine wash-out has been completed 11. If using angiotensin converting enzyme inhibitors or angiotensin receptor antagonists must be stable for at least 4 weeks prior to baseline assessment
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E.4 | Principal 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), cyclophosphamide, or cyclosporine A within 3 months of Baseline. 5. Treatment with biologic agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 12 months of study start. 6. Subjects having received B-cell depleting agents such as rituximab who have not yet normalized their B-cell count 7. Planned immunization with a live vaccine within 3 months prior to study treatment start and 3 months after treatment cessation 8. 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). 9. Clinically significant abnormalities on chest X-Ray or electrocardiogram that are not related to SLE, as defined by the Principal Investigator 10. 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, 11. Current drug and alcohol abuse as evidenced by medical history at Screening 12. Psychiatric, addictive, or any other disorder that compromises the ability to give truly informed written consent for participation in this study 13. Subjects with a history of severe allergic reactions to or hypersensitivity to any component of the drug or placebo 14. Has undergone or is undergoing treatment with another investigational drug within 6 months prior to entry in this study 15.Cyclophosphamide is not allowed within 12 months prior to study start and throughout the study
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |