Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001537-13-FR

Enrollment

120

Registered

2020-12-23

Start date

2021-03-25

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Ravulizumab Product Code: ALXN1210 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RAVULIZUMAB CAS Number: 1803171-55-2 Current Sponsor code: ALXN1210 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Common to both disease cohorts: - 18 - 75 years of age - Proteinuria = 1 (g/d or g/g) - Vaccinated against meningococcal infection - Vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae For LN cohort: - Diagnosis of active focal or diffuse proliferative LN Class III or IV - Clinical active LN, requiring/receiving immunosuppression induction treatment For IgAN cohort: - Diagnosis of primary IgAN - Compliance with stable and optimal dose of RAS inhibitor treatment for = 3 months For a full list of inclusion criteria please refer to the clinical study protocol, section 5.1. 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 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: Common to both disease cohorts: - Estimated GFR 20 mg for > 14 consecutive days or any other immunosuppression within 6 months For a full list of exclusion criteria please refer to the clinical study protocol, section 5.2.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of ravulizumab compared with placebo in adult participants with LN and IgAN;Secondary Objective: Safety and tolerability of ravulizumab and additional efficacy measures;Primary end point(s): Percentage change in proteinuria ;Timepoint(s) of evaluation of this end point: Baseline and Week 26	—

Secondary

Measure	Time frame
Secondary end point(s): Common to both disease cohorts: - Percentage change in proteinuria - Change from baseline in eGFR For LN: - Percentage of participants meeting the criteria for Complete Renal Response - Percentage of participants meeting the criteria for Partial Renal Response - Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g - Percentage of participants achieving corticosteroid taper to 7.5 mg/day - Percentage of participants with Renal Flare - Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare For IgAN: - Percentage of participants meeting the criteria for Partial Remission ;Timepoint(s) of evaluation of this end point: Throughout, Week 26 and/or Week 50	—

Measure

Time frame

Secondary end point(s): Common to both disease cohorts: - Percentage change in proteinuria - Change from baseline in eGFR For LN: - Percentage of participants meeting the criteria for Complete Renal Response - Percentage of participants meeting the criteria for Partial Renal Response - Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g - Percentage of participants achieving corticosteroid taper to 7.5 mg/day - Percentage of participants with Renal Flare - Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare For IgAN: - Percentage of participants meeting the criteria for Partial Remission ;Timepoint(s) of evaluation of this end point: Throughout, Week 26 and/or Week 50

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Countries

Australia, Belgium, Canada, France, Germany, Italy, Korea, Republic of, Netherlands, Poland, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

Public ContactEuropean Clinical Trial Information

Alexion Europe SAS

clinicaltrials.eu@alexion.com33789973326

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026