Back to resultsA Study of ANX009 in Adult Participants With Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ANX009
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: 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. NOTE: Other inclusion and/or exclusion criteria may apply.
Sites / Locations
- Annexon Investigational Site 203Recruiting
- Annexon Investigational Site 204Recruiting
- Annexon Investigational Site 201Recruiting
- Annexon Investigational Site 202Recruiting
- Annexon Investigational Site 101Recruiting
- Annexon Investigational Site 102Recruiting
- Annexon Investigational Site 103Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ANX009
Arm Description
Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary Outcome Measures
Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time
Change From Baseline in Complement Factor C4 Concentration and its Activation Product (Complement Component 4d [C4d]) in Plasma Over Time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05780515
Brief Title
A Study of ANX009 in Adult Participants With Lupus Nephritis
Official Title
A Single-Arm, Phase 1b, Open-Label Study to Assess the Safety, Tolerability, and Pharmacodynamics of Repeat-Doses of Subcutaneous ANX009 With Standard of Care Therapy in Adult Participants With Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Annexon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
All participants may continue to receive stable background standard of care therapy for LN and systemic lupus erythematosus (SLE) as permitted by the protocol (for example, mycophenolate mofetil [MMF], azathioprine, antimalarials, glucocorticoids, cyclosporin, voclosporin, tacrolimus, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs]).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANX009
Arm Type
Experimental
Arm Description
Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period.
Intervention Type
Biological
Intervention Name(s)
ANX009
Other Intervention Name(s)
Recombinant humanized immunoglobulin G1 (IgG1) Fab
Intervention Description
ANX009 will be administered per schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Baseline (Week 1) up to Week 15
Secondary Outcome Measure Information:
Title
Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time
Time Frame
Baseline (Week 1), up to Day 31
Title
Change From Baseline in Complement Factor C4 Concentration and its Activation Product (Complement Component 4d [C4d]) in Plasma Over Time
Time Frame
Baseline (Week 1), up to End of Study (up to Week 15)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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.
NOTE: Other inclusion and/or exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
1-650-822-5500
Email
clinicaltrials@annexonbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annexon Director Global Clinical Operations
Organizational Affiliation
Annexon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Annexon Investigational Site 203
City
Angeles City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Annexon Investigational Site 204
City
Iloilo City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Annexon Investigational Site 201
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Annexon Investigational Site 202
City
Quezon city
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Annexon Investigational Site 101
City
Taichung City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Annexon Investigational Site 102
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Annexon Investigational Site 103
City
Taoyuan County
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Study of ANX009 in Adult Participants With Lupus Nephritis
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