Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)

Study Identifier:
D9900C00002
ClinicalTrials.gov Identifier:
NCT07157787
EudraCT Identifier:
2025-520780-40
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN1920
  • Drug: Placebo
Date
Sep 2025 - Feb 2027
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
  • Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 50 RU/mL) at Screening, which must be confirmed by a central laboratory
  • Participants are willing to receive the background Standard of Care (SoC)
  • Participants at high risk for disease progression, defined as:
  • Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period.
  • Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \< 140 mmHg in ≥ 75% of the readings within last 8 weeks.
  • Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
  • All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
Exclusion Criteria
  • Estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m\^2 during Screening
  • Documented rapid deterioration of kidney function
  • History of life-threatening Nephrotic Syndrome within 1 year before Screening
  • Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R \< 50 RU/mL or kidney disease other than PMN
  • History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
  • History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period
  • History or presence of any clinically relevant co-morbidities
  • History of intolerance or hypersensitivity to ACEi or ARB
  • Use of SGLT2i, MRA, or ERA within 8 weeks prior to randomization and throughout the study period
  • Note: Additional inclusion/exclusion criteria may apply, per protocol.
Sex
Female & Male
Age
18 - 75 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN1920
  • Drug: Placebo
Date
Sep 2025 - Feb 2027
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
  • Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 50 RU/mL) at Screening, which must be confirmed by a central laboratory
  • Participants are willing to receive the background Standard of Care (SoC)
  • Participants at high risk for disease progression, defined as:
  • Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period.
  • Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \< 140 mmHg in ≥ 75% of the readings within last 8 weeks.
  • Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
  • All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
Exclusion Criteria
  • Estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m\^2 during Screening
  • Documented rapid deterioration of kidney function
  • History of life-threatening Nephrotic Syndrome within 1 year before Screening
  • Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R \< 50 RU/mL or kidney disease other than PMN
  • History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
  • History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period
  • History or presence of any clinically relevant co-morbidities
  • History of intolerance or hypersensitivity to ACEi or ARB
  • Use of SGLT2i, MRA, or ERA within 8 weeks prior to randomization and throughout the study period
  • Note: Additional inclusion/exclusion criteria may apply, per protocol.

Protocol Summary

The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).

Trial Locations

Location
Status
Location
Research Site
Loma Linda, California, United States, 92354
Status
Not yet recruiting
Location
Research Site
San Diego, California, United States, 92123
Status
Recruiting
Location
Research Site
Minneapolis, Minnesota, United States, 55435
Status
Recruiting
Location
Research Site
Rochester, Minnesota, United States, 55905
Status
Not yet recruiting
Location
Research Site
Houston, Texas, United States, 77030
Status
Not yet recruiting
Location
Research Site
Buenos Aires, Argentina, 1425
Status
Not yet recruiting
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