Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Study Identifier:
ALXN2050-NEPH-201
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
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
Omsk, Russian Federation, 644111
Status
Withdrawn
Location
Research Site
Moscow, Russian Federation, 111539
Status
Withdrawn
Location
Research Site
Kemerovo, Russian Federation, 650004
Status
Withdrawn
Location
Research Site
New York, NY, United States, 10016
Status
Completed
Location
Research Site
Roma, Italy, 00128
Status
Withdrawn
Location
Research Site
La Plata, Argentina, B1902COS
Status
Completed