E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10025140 |
E.1.2 | Term | Lupus nephritis |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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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 efficacy of nipocalimab vs. placebo in participants with active lupus nephritis (LN) |
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E.2.2 | Secondary objectives of the trial |
-To evaluate the safety and tolerability of nipocalimab in participants with active LN -To evaluate the pharmacokinetics (PK) and immunogenicity of nipocalimab in participants with active LN |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male or female, 18 to 75 years of age (inclusive) at the time of consent -Meets classification for SLE by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria. -Kidney biopsy documentation of ISN/RPS proliferative nephritis: Class III-IV (with or without concomitant Class V) within the last 6 months prior to screening or performed during screening. -UPCR ≥1.0 mg/mg assessed on 2 first morning urine void specimens during screening. -Must have received MMF or MPA for at least 8 weeks at the time of randomization, and currently receiving MMF at a dose of ≤3g/day or MPA at dose of ≤2.2 g/day with stable dose for at least 4 weeks prior to first administration of study intervention. -Currently receiving prednisone equivalent dose of 1 mg/kg/day or ≤60 mg/day whichever is lower, or less. Must be receiving prednisone equivalent of 10 mg/day or more at screening and randomization. Treated for ≥6 weeks with stable dosing ≥ 2 weeks prior to first administration of study intervention. |
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E.4 | Principal exclusion criteria |
-Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active LN. -Anticipated to require dialysis within 6 months. -Comorbidities (other than LN, eg, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months. -Has any unstable or progressive manifestation of SLE -Isolated Class V LN (ie, without coexistent/majority Class III or IV nephritis). -Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to RA, PsA, RA/lupus overlap, psoriasis, Crohn’s disease, or active Lyme disease. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants achieving complete renal response (CRR) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Proportion of participants achieving CRR 2. Proportion of participants achieving at least 50% decrease in proteinuria from baseline 3. Proportion of participants achieving at least 50% decrease in proteinuria from baseline 4. Proportion of participants achieving a sustained reduction in steroid dose ≤10 mg/day of prednisone or equivalent 5. Proportion of participants with treatment-emergent adverse events (AEs). 6. Proportion of participants with treatment-emergent serious adverse events (SAEs). 7. Serum nipocalimab concentrations over time 8. Incidence and titers of antibodies to nipocalimab |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Week 24 2. Week 24 3. Week 52 4. Week 52 5. Throughout the study 6. Throughout the study 7. Throughout the study 8. Throughout the study |
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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 | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarkers and Immunogenicity Assessments |
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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 | No |
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.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 | No |
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 |
Colombia |
Hong Kong |
Israel |
Japan |
Korea, Republic of |
Panama |
Russian Federation |
South Africa |
Taiwan |
Ukraine |
United States |
France |
Germany |
Italy |
Portugal |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 13 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 13 |