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

Study Identifier:
ALXN1210-NEPH-202
ClinicalTrials.gov Identifier:
NCT04564339
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Lupus
  • Unmapped
Study Drug
  • Drug: Ravulizumab
  • Drug: Placebo
Date
Jan 2021 - Mar 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Common to both disease cohorts:
  • Proteinuria ≥1 (gram \[g\]/day or g/g)
  • Vaccinated against meningococcal infection
  • Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements
  • For LN cohort:
  • Diagnosis of active focal or diffuse proliferative LN Class III or IV
  • Clinically active LN, requiring/receiving immunosuppression induction treatment
  • For IgAN cohort:
  • Diagnosis of primary IgAN
  • Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months
Exclusion Criteria
  • Common to both disease cohorts:
  • eGFR \< 30 milliliters/minute/1.73 meters squared
  • Previously received a complement inhibitor (for example, eculizumab)
  • Concomitant significant renal disease other than LN or IgAN
  • History of other solid organ or bone marrow transplant
  • Uncontrolled hypertension
  • For IgAN cohort:
  • Diagnosis of rapid progressive glomerulonephritis
  • Prednisone or prednisone equivalent \> 20 milligram (mg) per day for \> 14 consecutive days or any other immunosuppression within 6 months
Sex
Female & Male
Age
18 - 75 Years

Study Details

Medical Condition
  • Lupus
  • Unmapped
Study Drug
  • Drug: Ravulizumab
  • Drug: Placebo
Date
Jan 2021 - Mar 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Common to both disease cohorts:
  • Proteinuria ≥1 (gram \[g\]/day or g/g)
  • Vaccinated against meningococcal infection
  • Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements
  • For LN cohort:
  • Diagnosis of active focal or diffuse proliferative LN Class III or IV
  • Clinically active LN, requiring/receiving immunosuppression induction treatment
  • For IgAN cohort:
  • Diagnosis of primary IgAN
  • Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months
Exclusion Criteria
  • Common to both disease cohorts:
  • eGFR \< 30 milliliters/minute/1.73 meters squared
  • Previously received a complement inhibitor (for example, eculizumab)
  • Concomitant significant renal disease other than LN or IgAN
  • History of other solid organ or bone marrow transplant
  • Uncontrolled hypertension
  • For IgAN cohort:
  • Diagnosis of rapid progressive glomerulonephritis
  • Prednisone or prednisone equivalent \> 20 milligram (mg) per day for \> 14 consecutive days or any other immunosuppression within 6 months

Protocol Summary

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

Trial Locations

Location
Status
Location
Research Site
San Dimas, California, United States, 91773
Status
N/A
Location
Research Site
Santa Monica, California, United States, 90404
Status
N/A
Location
Research Site
South Gate, California, United States, 90280
Status
N/A
Location
Research Site
Stanford, California, United States, 94305
Status
N/A
Location
Research Site
Orlando, Florida, United States, 32835
Status
N/A
Location
Research Site
Plantation, Florida, United States, 33324
Status
N/A
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