Lupus NephritisPhase 1NCT05780515
A Study of ANX009 in Adult Participants With Lupus Nephritis
A Phase 1 study testing ANX009 in people with Lupus Nephritis, run by Annexon, Inc. at 7 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- ANX009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 9 Aug 2022to 31 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Philippines4 sites
Annexon Investigational Site 203
Angeles City
Annexon Investigational Site 204
Iloilo City
Annexon Investigational Site 201
Manila
Annexon Investigational Site 202
Quezon City
Taiwan3 sites
Annexon Investigational Site 101
Taichung
Annexon Investigational Site 102
Taipei
Annexon Investigational Site 103
Taoyuan County
About this study
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
The main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).
Read the 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]).
- Conditions
- Lupus Nephritis
- Being tested
- ANX009
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANX009Biological
Also called Recombinant humanized immunoglobulin G1 (IgG1) Fab
ANX009 will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| ANX009 | Experimental | Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period. Receives: Biological: ANX009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Baseline (Week 1) up to Week 15
Secondary outcomes (2)
Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time
Measured: 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
Measured: Baseline (Week 1), up to End of Study (up to Week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start9 Aug 2022
- Primary completion31 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annexon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annexon Director Global Clinical Operations, Study director, Annexon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780515
- Sponsor's protocol ID
- ANX009-LN-01
- Status last verified
- Aug 2024
- First submitted
- 10 Mar 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05780515
- Acronym / sponsor ID
- ANX009-LN-01
- Conditions
- Lupus Nephritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Annexon, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANX009 | Experimental | Biological: ANX009Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANX009Also: Recombinant humanized immunoglobulin G1 (IgG1) FabANX009 will be administered per schedule specified in the arm description. | Biological | ANX009 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline (Week 1) up to Week 15
2 secondary outcomes
Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time
Time frame: 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
Time frame: Baseline (Week 1), up to End of Study (up to Week 15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annexon Director Global Clinical Operations study director
Annexon, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANX009 in people with Lupus Nephritis, run by Annexon, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Philippines, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline (Week 1) up to Week 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.