Lupus Nephritis (LN)Phase 1NCT06975787
Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis
A Phase 1 study testing Vonsetamig and Odronextamab in people with Lupus Nephritis (LN), run by Regeneron Pharmaceuticals at 19 sites in 6 countries.
Trial summary
This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN). The main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lupus Nephritis (LN)
- What is being tested?
- Vonsetamig and Odronextamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 22 Dec 2025to 10 Sep 2029
- Phase
- Phase 1
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 60 years
- All sexes
- No healthy volunteers
- Adult
Key General Inclusion Criteria:
- Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol
- Participant must have refractory or relapsed disease, as described in the protocol
Key General Exclusion Criteria:
- History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization
- Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
- Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening
NOTE: Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
19 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 6 countries
Spain5 sites, 5 recruiting
- Recruiting
Hospital Gregorio Maranon
Madrid, 28007
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 290090
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
South Korea4 sites, 4 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
Yonsei University College of Medicine, Severance Hospital
Seoul, 3722
Taiwan4 sites, 4 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, 500
- Recruiting
Taichung General Veterans Hospital
Taichung, 40705
- Recruiting
National Taiwan University Hospital
Taipei, 106
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
United States3 sites, 3 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University of California San Francisco - Zuckerberg San Francisco General
San Francisco, California, 94110
Germany2 sites, 2 recruiting
- Recruiting
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, 55131
- Recruiting
University Hospital Regensburg
Regensburg, Bavaria, D-93053
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire (CHU) Bordeaux
Bordeaux, New Aquitaine, 33076
About this study
Official title: A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis
This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN).
The main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up.
Read more
This is a main study, called an umbrella study, which includes several independent smaller sub-studies. Each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating LN.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
- Conditions
- Lupus Nephritis (LN)
- Being tested
- Vonsetamig, Odronextamab
- Keywords
- Bispecific Antibodies (bsAb), Double-stranded DNA (dsDNA), LN class III or IV, Systemic Lupus Erythematosus (SLE)
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonsetamigDrug
Also called REGN5459
Administered as per the protocol
OdronextamabDrug
Also called REGN1979
Administered as per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm 1: Vonsetamig | Experimental | Not described Receives: Drug: Vonsetamig |
| Experimental Arm 2: Odronextamab | Experimental | Not described Receives: Drug: Odronextamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicities (DLT)
Measured: Up to 56 days
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Measured: Through week 76
Severity of TEAEs
Measured: Through week 76
Secondary outcomes (30)
Proportion of participants no longer receiving a corticosteroid
Measured: At 6 months
Cumulative total exposure to corticosteroids
Measured: At 76 weeks
Absolute values of urine Protein-Creatinine Ratio (uPCR)
Measured: Through week 76
Percent change from baseline of uPCR
Measured: Through week 76
Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine
Measured: Through week 76
Percent change from baseline of eGFR serum creatinine
Measured: Through week 76
Absolute values of blood B-cell counts and other immune cell populations
T cells and Natural Killer (NK) cells
Measured: Through week 76
Change from baseline of blood B-cell counts and other immune cell populations
T cells and NK cells
Measured: Through week 76
Absolute values of double-stranded DNA (dsDNA) antibodies
Measured: Through week 76
Percent change from baseline of dsDNA antibodies
Measured: Through week 76
Absolute values of anti-Smith antibodies
Measured: Through week 76
Percent change from baseline of anti-Smith antibodies
Measured: Through week 76
Absolute values of anti-C1q antibodies
Measured: Through week 76
Percent change from baseline of anti-C1q antibodies
Measured: Through week 76
Absolute values of other autoantibodies
anti-nucleosome
Measured: Through week 76
Percent change from baseline of other autoantibodies
anti-nucleosome
Measured: Through week 76
Absolute values of Complement Factor C3 (C3) circulating factors
Measured: Through week 76
Percent change from baseline of C3 circulating factors
Measured: Through week 76
Absolute values of Complement Factor C4 (C4) circulating factors
Measured: Through week 76
Percent change from baseline of C4 circulating factors
Measured: Through week 76
Absolute values of serum levels of Immunoglobulin A (IgA)
Measured: Through week 76
Percent change from baseline of serum levels of IgA
Measured: Through week 76
Absolute values of serum levels of Immunoglobulin G (IgG)
Measured: Through week 76
Percent change from baseline of serum levels of IgG
Measured: Through week 76
Concentrations of vonsetamig in serum
Measured: Through week 76
Concentrations of odronextamab in serum
Measured: Through week 76
Occurence of Anti-Drug Antibodies (ADAs) to vonsetamig
Measured: Through week 76
Occurence of ADAs to odronextamab
Measured: Through week 76
Magnitude of ADAs to vonsetamig
Measured: Through week 76
Magnitude of ADAs to odronextamab
Measured: Through week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start22 Dec 2025
- Primary completion10 Sep 2029 (estimated)
- Study completion10 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975787
- Sponsor's protocol ID
- R5459-1979-LN-2459
- Other IDs
- 2024-518288-37-00
- Status last verified
- Sep 2026
- First submitted
- 8 May 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.