Systemic Lupus ErythematosusPhase 1NCT06041568
A Study of Imvotamab in Severe Systemic Lupus Erythematosus
A Phase 1 study testing Imvotamab in people with Systemic Lupus Erythematosus and Lupus Erythematosus, run by IGM Biosciences, Inc. at 10 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies. Participants will be given imvotamab through a vein (i.e., intravenously). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Erythematosus
- What is being tested?
- Imvotamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 15 Aug 2023to 27 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of signing ICF
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
- Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ≥ 10 at screening
- Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
- It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week 8.
Who cannot join
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
- Any lupus-associated neuropsychiatric disease.
- Active lupus nephritis with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
- Prednisone-equivalent > 30 mg/day, including immediate and extended-release oral formulations.
- Drug-induced lupus.
- Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States8 sites
Stryde Research
Allen, Texas, 75013
Omega Research, DeBary
DeBary, Florida, 32713
Precision Comprehensive Clinical Research
Grapevine, Texas, 76051
Prolato Clinical Research Center
Houston, Texas, 77054
Care and Cure Clinic
Houston, Texas, 77090
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324
TriWest Research Associates
San Diego, California, 92108
East Bay Rheumatology
San Leandro, California, 94578
Poland1 site
Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie
Nadarzyn
About this study
Official title: A Phase 1b, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Severe Systemic Lupus Erythematosus Who Have Failed Standard Therapies
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies.
Participants will be given imvotamab through a vein (i.e., intravenously).
Read the detailed description
This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with systemic lupus erythematosus (SLE). Approximately 18 participants will be assigned to different sequentially dose escalation cohorts.
- Conditions
- Systemic Lupus Erythematosus, Lupus Erythematosus
- Being tested
- Imvotamab
- Keywords
- Lupus, SLE, Severe Lupus, Severe systemic lupus erythematosus, Systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImvotamabDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Imvotamab (Dose Escalation) | Experimental | Imvotamab administered intravenously Receives: Drug: Imvotamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of imvotamab
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start15 Aug 2023
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Why it stopped: Company Decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- IGM Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Kunder, Study director, IGM Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041568
- Sponsor's protocol ID
- IGM-2323-101
- Status last verified
- Feb 2025
- First submitted
- 11 Sep 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Severe Systemic Lupus Erythematosus Who Have Failed Standard Therapies
- ClinicalTrials.gov ID
- NCT06041568
- Acronym / sponsor ID
- IGM-2323-101
- Conditions
- Systemic Lupus Erythematosus, Lupus Erythematosus
- Keywords
- Lupus, SLE, Severe Lupus, Severe systemic lupus erythematosus, Systemic lupus erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Decision.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- IGM Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 18 Sep 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 purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies.
Participants will be given imvotamab through a vein (i.e., intravenously).
Detailed description
This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with systemic lupus erythematosus (SLE). Approximately 18 participants will be assigned to different sequentially dose escalation cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imvotamab (Dose Escalation) | Experimental | Drug: ImvotamabImvotamab administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years at the time of signing ICF
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
- Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ≥ 10 at screening
- Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
- It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week 8.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
- Any lupus-associated neuropsychiatric disease.
- Active lupus nephritis with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
- Prednisone-equivalent > 30 mg/day, including immediate and extended-release oral formulations.
- Drug-induced lupus.
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 |
|---|---|---|
| ImvotamabAdministered intravenously | Drug | Imvotamab (Dose Escalation) |
Primary outcome
Safety and tolerability of imvotamab
Time frame: Up to Week 52
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections
Results and safety
The study was stopped early (reason given: Company Decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Rebecca Kunder study director
IGM Biosciences
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imvotamab in people with Systemic Lupus Erythematosus and Lupus Erythematosus, run by IGM Biosciences, Inc. at 10 sites in 3 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 6 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: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Poland, South Korea. 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 was stopped early (reason given: Company Decision.). Results are not available in the source record.
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?
Safety and tolerability of imvotamab (time frame: Up to Week 52). 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 10 Feb 2025.