NCT05780515

Brief Summary

The main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2022

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

March 10, 2023

Last Update Submit

August 20, 2024

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Baseline (Week 1) up to Week 15

Secondary Outcomes (2)

  • Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time

    Baseline (Week 1), up to Day 31

  • Change From Baseline in Complement Factor C4 Concentration and its Activation Product (Complement Component 4d [C4d]) in Plasma Over Time

    Baseline (Week 1), up to End of Study (up to Week 15)

Study Arms (1)

ANX009

EXPERIMENTAL

Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period.

Biological: ANX009

Interventions

ANX009BIOLOGICAL

ANX009 will be administered per schedule specified in the arm description.

Also known as: Recombinant humanized immunoglobulin G1 (IgG1) Fab
ANX009

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who have a diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 Criteria
  • Has a history of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV with or without Class V glomerulonephritis on renal biopsy within 24 months prior to screening or as performed during screening.
  • Has proteinuria level between ≥0.5 to 3.0 grams (g)/g/day assessed via urine protein to creatine ratio (UPCR) during screening.
  • Has evidence of classical complement activation at screening
  • Has a history of receiving one or more standard therapies for LN

You may not qualify if:

  • Has a history of ISN/RPS Class VI or isolated Class V (without co-existent/predominant Class III or IV glomerulonephritis) glomerulonephritis on renal biopsy.
  • Has severe kidney disease defined as eGFR of \<30 milliliters (mL)/minute/1.73 square meter (m\^2) or end-stage renal disease (ESRD) requiring dialysis or kidney transplantation.
  • Has a concurrent systemic autoimmune disease that may confound study assessments other than SLE, LN, or cutaneous lupus erythematosus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Annexon Investigational Site 203

Angeles City, Philippines

Location

Annexon Investigational Site 204

Iloilo City, Philippines

Location

Annexon Investigational Site 201

Manila, Philippines

Location

Annexon Investigational Site 202

Quezon City, Philippines

Location

Annexon Investigational Site 101

Taichung, Taiwan

Location

Annexon Investigational Site 102

Taipei, Taiwan

Location

Annexon Investigational Site 103

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Immunoglobulin GImmunoglobulin Fab Fragments

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsImmunoglobulin FragmentsPeptide FragmentsPeptides

Study Officials

  • Annexon Director Global Clinical Operations

    Annexon, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

August 9, 2022

Primary Completion

August 31, 2023

Study Completion

October 31, 2023

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations

TW(3)PH(4)