A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

  • STATUS
    Recruiting
  • End date
    Aug 24, 2026
  • participants needed
    126
  • sponsor
    Alexion Pharmaceuticals
Updated on 21 October 2022
angiotensin
nephropathy
immunosuppression
rheumatism
proteinuria
lupus
enzyme inhibitor
hematuria
microscopic examination
immunoglobulin a
kidney biopsy
nephritis

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years.

Safety will be monitored throughout the study.

Details
Condition Lupus Nephritis, Immunoglobulin A Nephropathy, IgAN, LN
Treatment Placebo, ALXN2050
Clinical Study IdentifierNCT05097989
SponsorAlexion Pharmaceuticals
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

LN Cohort
Clinical diagnosis of SLE by 2019 American College of Rheumatology and European League Against Rheumatism criteria
Diagnosis of 2018 Revised International Society of Nephrology/Renal Pathology Society classification (active focal or diffuse proliferative LN Class III or IV) confirmed by biopsy obtained ≤ 6 months prior to Screening or during Screening Period. Participants may co-exhibit Class V disease. Participants with de novo or relapsing disease may be eligible
Clinically active LN at Screening requiring/receiving immunosuppression induction treatment in the opinion of the Investigator
Proteinuria with UPCR ≥ 1 g/g based on one 24 hour urine collection during the Screening Period
IgAN Cohort
Established diagnosis of primary IgAN based on kidney biopsy obtained any time prior to or during the Screening Period
Mean proteinuria ≥ 1 g/day on 2 complete and valid 24 hour urine collections during the Screening Period
Presence of hematuria as defined by 1+ blood based on urine dipstick or ≥ 10 red blood cells/high power field microscopy on urine sediment (performed by the local laboratory) during Screening Period (only applicable if diagnostic biopsy is >2 years prior to Screening)
Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated angiotensin converting enzyme inhibitor and/or angiotensin receptor blocker dose for ≥ 3 months prior to Screening with no expected change in dose during the study (participants with established intolerance to RAS inhibitors may be included)
Controlled and stable blood pressure (defined as < 140/90 millimeters of mercury [mmHg]) over the past 3 months prior to randomization

Exclusion Criteria

Both Cohorts
eGFR ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration
More than or equal to 50% interstitial fibrosis, tubular atrophy, glomerular sclerosis, or crescent formation in glomeruli on most recent kidney biopsy prior or during the Screening Period
Concomitant significant renal disease other than LN or IgAN on the most recent biopsy prior to or during the Screening Period
History of solid organ or bone marrow transplant, or planned transplant during the Extended Treatment Period (50 weeks)
Splenectomy or functional asplenia
Known or suspected complement deficiency, unless attributable to underlying disease (that is, LN and IgAN)
Bone marrow insufficiency with absolute neutrophil count < 1.3 × 10^3/microliter; thrombocytopenia (platelet count < 50,000/cubic millimeter)
For LN Cohort
Participants who have received any of the following treatments
Cyclophosphamide ≤ 6 months prior to Screening
Calcineurin inhibitors ≤ 3 months prior to Screening
A cumulative dose of intravenous methylprednisolone > 3 g for the current active renal flare
Mycophenolate mofetil > 2 g/day (or equivalent) for ≥ 4 consecutive weeks prior to Screening for the current active renal flare
Prednisone or prednisone equivalent ≥ 0.5 mg/kilogram/day for ≥ 4 consecutive weeks prior to Screening for the current active renal flare
Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood
pressure > 110 mmHg) on 2 or more measurements during the Screening Period
For IgAN Cohort
Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 30% over a period of 3 months prior to or during the Screening Period
Secondary etiologies of IgAN
Prednisone or prednisone equivalent > 20 mg for > 14 consecutive days or any other immunosuppression within 6 months prior to Screening
Blood pressure of ≥ 140/90 mmHg during the Screening Period confirmed on 2 measures > 30 minutes apart
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