A Study of ANX009 in Adult Participants With Lupus Nephritis

• Sponsor: Annexon, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05780515
• Collaborator: (none)
• Enrollment: 7
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 13.7
• Patient Per Site: 1
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Biological: ANX009	Phase 1

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]).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 9, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ANX009 Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period.	Biological: ANX009; ANX009 will be administered per schedule specified in the arm description.; Other Names: Recombinant humanized immunoglobulin G1 (IgG1) Fab

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Baseline (Week 1) up to Week 15]

Secondary Outcome Measures

1. Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time [Baseline (Week 1), up to Day 31]

2. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Annexon Investigational Site 203	Angeles City		Philippines
2	Annexon Investigational Site 204	Iloilo City		Philippines
3	Annexon Investigational Site 201	Manila		Philippines
4	Annexon Investigational Site 202	Quezon city		Philippines
5	Annexon Investigational Site 101	Taichung City		Taiwan
6	Annexon Investigational Site 102	Taipei		Taiwan
7	Annexon Investigational Site 103	Taoyuan County		Taiwan

Sponsors and Collaborators

• Annexon, Inc.

Investigators

• Study Director: Annexon Director Global Clinical Operations, Annexon, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Annexon, Inc.
• ClinicalTrials.gov Identifier: NCT05780515
• Other Study ID Numbers: ANX009-LN-01
• First Posted: Mar 22, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nephritis; Lupus Nephritis; Immunoglobulins; Immunoglobulin G

Study Results

No Results Posted as of Mar 22, 2023