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Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

Primary Purpose

Proteinuria

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ALXN1720

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring Proteinuria, Glomerular Disease, Chronic Kidney Disease, Lupus Nephritis, Immunoglobulin A Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy, Membranoproliferative Glomerulonephritis (all forms)

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Trial Site 2
Clinical Trial Site 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALXN1720

Arm Description

Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg.

Outcomes

Primary Outcome Measures

Serum Concentration of ALXN1720

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events

Serum Concentration of Free and Total Complement Component 5 (C5)

Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720

Full Information

NCT ID

NCT05314231

First Posted

March 29, 2022

Last Updated

June 28, 2023

Sponsor

Alexion

1. Study Identification

Unique Protocol Identification Number

NCT05314231

Brief Title

Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

June 29, 2022 (Actual)

Primary Completion Date

May 31, 2023 (Actual)

Study Completion Date

May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proteinuria

Keywords

Proteinuria, Glomerular Disease, Chronic Kidney Disease, Lupus Nephritis, Immunoglobulin A Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy, Membranoproliferative Glomerulonephritis (all forms)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALXN1720

Arm Type

Experimental

Arm Description

Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg.

Intervention Type

Drug

Intervention Name(s)

ALXN1720

Intervention Description

All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days).

Primary Outcome Measure Information:

Title

Serum Concentration of ALXN1720

Time Frame

Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events

Time Frame

Day 1 (Predose) through Follow-up (Day 92)

Title

Serum Concentration of Free and Total Complement Component 5 (C5)

Time Frame

Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57

Title

Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720

Time Frame

Day 1 (predose) through Day 57

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Clinical Trial Site 2

City

Anyang-Si

State/Province

Gyeonggi-do

ZIP/Postal Code

14068

Country

Korea, Republic of

Facility Name

Clinical Trial Site 1

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

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Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

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