A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1920 in Adult Participants With PMN (Primary Membranous Nephropathy) Who Are at a High Risk for Disease Progression
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Research Site
NOT_YET_RECRUITING
Loma Linda
Research Site
NOT_YET_RECRUITING
San Diego
Minnesota
Research Site
NOT_YET_RECRUITING
Minneapolis
Research Site
NOT_YET_RECRUITING
Rochester
Texas
Research Site
NOT_YET_RECRUITING
Houston
Other Locations
Argentina
Research Site
NOT_YET_RECRUITING
Buenos Aires
Research Site
NOT_YET_RECRUITING
Caba
Research Site
NOT_YET_RECRUITING
Ciudad De Buenos Aires
Research Site
NOT_YET_RECRUITING
Rosario
Research Site
WITHDRAWN
Santa Fe
Research Site
WITHDRAWN
Santa Fe
Australia
Research Site
RECRUITING
Gosford
Research Site
NOT_YET_RECRUITING
Parkville
Research Site
RECRUITING
Southport
Brazil
Research Site
NOT_YET_RECRUITING
Recife
Research Site
NOT_YET_RECRUITING
Salvador
Research Site
NOT_YET_RECRUITING
São Paulo
Research Site
NOT_YET_RECRUITING
São Paulo
China
Research Site
NOT_YET_RECRUITING
Baotou
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Shenzhen
France
Research Site
NOT_YET_RECRUITING
Créteil
Research Site
NOT_YET_RECRUITING
Nice
Research Site
NOT_YET_RECRUITING
Toulouse
Italy
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Ranica
Research Site
NOT_YET_RECRUITING
Torrette
Spain
Research Site
NOT_YET_RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Seville
Research Site
NOT_YET_RECRUITING
Toledo
Taiwan
Research Site
NOT_YET_RECRUITING
Kaohsiung City
Research Site
RECRUITING
Taichung
Research Site
NOT_YET_RECRUITING
Taoyuan District
United Kingdom
Research Site
NOT_YET_RECRUITING
Cambridge
Research Site
NOT_YET_RECRUITING
Leicester
Research Site
NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
Salford
Contact Information
Primary
Alexion Pharmaceuticals, Inc. (Sponsor)
clinicaltrials@alexion.com
1-855-752-2356
Time Frame
Start Date:2025-09-19
Estimated Completion Date:2027-02-12
Participants
Target number of participants:30
Treatments
Experimental: ALXN1920
Participants will receive ALXN1920 subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.
Experimental: Placebo
Participants will receive placebo subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.