Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

A Phase 1b, Open-Label, Single-Dose Pharmacokinetic Study of Subcutaneous ALXN1720 in Adult Participants With Varying Degrees of Proteinuria

The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.

Study Overview

• Status: Completed
• Conditions: Proteinuria
• Intervention / Treatment: Drug: ALXN1720

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Clinical Trial Site 1
  • Gyeonggi-do
    • Anyang-Si, Gyeonggi-do, Korea, Republic of, 14068
      • Clinical Trial Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor
• Proteinuria >=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening
• Body weight ≥ 40 kg at Screening

Exclusion Criteria:

• Kidney transplant
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 during Screening
• Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
• Treatment with complement inhibitors at any time.
• Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day 1.
• Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALXN1720; Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg.	Drug: ALXN1720; All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Concentration of ALXN1720	Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment-Emergent Adverse Events	Day 1 (Predose) through Follow-up (Day 92)
Serum Concentration of Free and Total Complement Component 5 (C5)	Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57
Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720	Day 1 (predose) through Day 57

Collaborators and Investigators

• Sponsor: Alexion

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Proteinuria; Glomerular Disease; Lupus Nephritis; Diabetic Nephropathy; Focal Segmental Glomerulosclerosis; Minimal Change Disease; Primary Membranous Nephropathy; Immunoglobulin A Nephropathy; Hypertensive Nephrosclerosis; Thin Basement Membrane Nephropathy; Membranoproliferative Glomerulonephritis (all forms)
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Proteinuria
• Other Study ID Numbers: ALXN1720-NEPH-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No