Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Study Identifier:
ALXN2050-NEPH-201
ClinicalTrials.gov Identifier:
NCT05097989
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Lupus
  • Unmapped
Study Drug
  • Drug: ALXN2050
  • Drug: Placebo
Date
Jan 2022 - Dec 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Sex
Female & Male
Age
18 - 75 Years

Study Details

Medical Condition
  • Lupus
  • Unmapped
Study Drug
  • Drug: ALXN2050
  • Drug: Placebo
Date
Jan 2022 - Dec 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years years
Requirements Information

Protocol 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.

Trial Locations

Location
Status
Location
Research Site
Huntsville, Alabama, United States, 35805
Status
N/A
Location
Research Site
Tucson, Arizona, United States, 85723
Status
N/A
Location
Research Site
La Jolla, California, United States, 92093
Status
N/A
Location
Research Site
Loma Linda, California, United States, 92350
Status
N/A
Location
Research Site
Northridge, California, United States, 91324
Status
N/A
Location
Research Site
Coral Springs, Florida, United States, 33065
Status
N/A