A Study of ANX009 in Adult Participants With Lupus Nephritis

Lupus Nephritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780515
• Other study ID #: ANX009-LN-01
• Status: Recruiting
• Phase: Phase 1
• Start date: August 9, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: Annexon, Inc.
• Contact: Study Coordinator
• Phone: 1-650-822-5500
• Email: clinicaltrials[@]annexonbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

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

Locations

Country	Name	City	State
Philippines	Annexon Investigational Site 203	Angeles City
Philippines	Annexon Investigational Site 204	Iloilo City
Philippines	Annexon Investigational Site 201	Manila
Philippines	Annexon Investigational Site 202	Quezon city
Taiwan	Annexon Investigational Site 101	Taichung City
Taiwan	Annexon Investigational Site 102	Taipei
Taiwan	Annexon Investigational Site 103	Taoyuan County

Sponsors (1)

Lead Sponsor	Collaborator
Annexon, Inc.

Countries where clinical trial is conducted

Philippines,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)		Baseline (Week 1) up to Week 15
Secondary	Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time		Baseline (Week 1), up to Day 31
Secondary	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)