Clinical trial NCT05780515: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus Nephritis
Lead sponsor: Annexon, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-22
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[ARBs\]).

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline (Week 1) up to Week 15
Secondary outcomes:
measure: Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time
timeFrame: Baseline (Week 1), up to Day 31
measure: Change From Baseline in Complement Factor C4 Concentration and its Activation Product (Complement Component 4d [C4d]) in Plasma Over Time
timeFrame: Baseline (Week 1), up to End of Study (up to Week 15)
Other outcomes:
Locations:
city: Angeles City
country: Philippines
facility: Annexon Investigational Site 203
city: Iloilo City
country: Philippines
facility: Annexon Investigational Site 204
city: Manila
country: Philippines
facility: Annexon Investigational Site 201
city: Quezon city
country: Philippines
facility: Annexon Investigational Site 202
city: Taichung City
country: Taiwan
facility: Annexon Investigational Site 101
city: Taipei
country: Taiwan
facility: Annexon Investigational Site 102
city: Taoyuan County
country: Taiwan
facility: Annexon Investigational Site 103
Study officials:
affiliation: Annexon, Inc.
name: Annexon Director Global Clinical Operations
role: STUDY_DIRECTOR
References: