Systemic Lupus ErythematosusPhase 1ELEVATE-1NCT07371468
A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
A Phase 1 study testing GSK5926371 in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 19 sites in 9 countries.
Trial summary
This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- GSK5926371
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 19 sitesin 9 countries
- Study dates
- 10 Feb 2026to 15 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1 will enroll adult participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).
- Part 2 will enroll adult participants with SLE, RA, idiopathic inflammatory myopathies (IIM) or Sjogren's disease (SjD).
- Participants must be 18 to 70 years of age inclusive at the time of signing the informed consent form.
- Body mass index (BMI) between 18-35 kilograms per square meter (kg/m^2) inclusive with a body weight of greater than or equal to (>=) 45 kilograms (kg).
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a participant of non-childbearing potential (PONCBP), OR
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- Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<) 1 percent (%), 28 days prior to and during the study intervention period and for at least 28 weeks after the first dose of GSK5926371. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention.
- A POCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Signed and dated informed consent form indicating that the participant is willing and able to comply with hospitalization, clinic visits and scheduled study assessments as detailed in the protocol.
Who cannot join
- Any acute, severe autoimmune disease-related flare before, or during the Screening Period (up to and including Day 1) that needs immediate treatment or is expected to require escalation of treatment to prohibited medications for the duration of the study.
- Significant allergies to humanized monoclonal antibodies or significant sensitivity to any constituents of the study drug (including excipients).
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to the autoimmune condition under study (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, or infectious diseases) and/or a planned surgical procedure, which, in the opinion of the investigator, could confound the results of the clinical study or put the participant at undue risk.
- Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data.
- Participant has a diagnosis of primary or acquired immunodeficiency, except for selective IgA deficiency.
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- Have an acute or chronic infection including requiring management as follows:
- An acute infection within 2 weeks of dosing on Day 1.
- An active infection requiring current systemic antibiotic, antiviral or anti-fungal treatment with the exception of topical treatments for fungal nail infections. Prophylactic medications are permitted.
- History of, or currently being treated for, a clinically significant recurrent or chronic infection (except for minor localized infections, for example tinea pedis).
- Any opportunistic infections within past 3 years. Uncomplicated herpes zoster, localized herpes simplex virus, and oral candidiasis are not considered as opportunistic infections for this purpose.
- Herpes zoster within 3 months before screening.
- A serious infection requiring treatment with intravenous (IV)/intramuscular (IM) antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 30 days of the first day of dosing (Day 1).
- History of a serious infection associated with low serum immunoglobulin levels.
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination (including chest X-rays [CXR], if available), and a positive (not indeterminate) TB test such as QuantiFERON-TB Gold Plus test. In cases where the QuantiFERON test is indeterminate, the participant may have the test repeated once, but if the test remains indeterminate further investigation may be required including CXR (posteroanterior [PA] and lateral) in order to exclude TB. Note: The QuantiFERON-TB Gold Plus test can only be used in countries where it is licensed, and the use of this test is dependent on previous treatment(s). This test may not be suitable if previous treatment(s) produced significant immunosuppression.
- Confirmed progressive multifocal leukoencephalopathy (PML) within 12 months or has unexplained or deteriorating neurologic signs and symptoms.
- History or positive test at Screening for human immunodeficiency virus (HIV).
- History of clinically significant neurological or psychiatric disorder including history of epilepsy, dementia, increased risk of suicide as judged by the investigator or major depression deemed to interfere with study assessments, or a history of intracranial hemorrhage.
- Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years. The investigator should also ensure that occult malignancy associated with the autoimmune condition under study has been adequately ruled out prior to screening (for example, malignancy-associated dermatomyositis).
- History of hematological or solid organ transplant.
- Live or live-attenuated vaccine(s) within 30 days before Screening or plans to receive such vaccines during the screening period or during the clinical study.
- Current or prior treatment with any of the medications specified below during the relevant exclusion periods prior to Day 1. The following medications are prohibited from the periods before the study, until the last study visit:
- IV or IM dose of corticosteroids within 5 weeks of Day 1.
- Any T-cell engager (TCE) including blinatumomab, mosunetuzumab or other approved or investigational T cell engagers within 12 months of Day 1.
- Chimeric antigen receptor (CAR)-T-cell treatment, at any time.
- B-cell depleting agents, including but not limited to anti-CD20 (e.g. Rituximab, Obinutuzumab, Ocrelizumab), anti-CD38 (e.g. Daratumumab, TAK079, MOR202, isatuximab) within 4 months of Day 1.
- Belimumab within 8 weeks of Day 1.
- Anifrolumab within 8 weeks of Day 1.
- Oral or IV cyclophosphamide within 12 weeks of Day 1.
- Immune-Modulating Biologic agents, including anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab and etanercept), abatacept, and interleukin (IL)-1 receptor antagonist [anakinra] or IL-6 receptor antagonist (tocilizumab) within 4 weeks of Day 1. Except infliximab, golimumab, and certolizumab within 8 weeks of Day 1. (NOTE: tocilizumab is permitted for cytokine release syndrome (CRS) Grade 3/4 management after dosing)
- Small molecule inhibitors, including tyrosine kinase 2 inhibitor (TYK2i, Deucravacitinib); inhibitors of Janus kinases (JAKis, baricitinib, tofacitinib, upadacitinib, filgotinib); or Bruton tyrosine kinase inhibitors (ibrutinib, fenebrutinib) within 4 weeks of Day 1.
- IV immunoglobulin within 8 weeks of Day 1.
- Plasmapheresis within 8 weeks of Day 1.
- Current enrolment or past participation in any other clinical study involving an investigational study treatment (including investigational vaccines) within 3 months or 5 half-lives of the investigational drug or twice the duration of pharmacological activity (whichever is longer) before Day 1.
- Contra-indications to prophylactic medications for CRS (corticosteroid, ant histamines and antipyretics), or CRS rescue medication (tocilizumab or IV corticosteroids).
- Current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 12 months before Day 1.
- Alanine transaminase (ALT) greater than (>) 1.5 x upper limit of normal (ULN).
- Total bilirubin > 1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin > 1.5 x ULN if direct bilirubin is > 1.5 x ULN.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
- Presence of hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.
- Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. Note: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
- Corrected QT (QTc) interval > 450 milliseconds (msec) or QTc interval > 480 msec for participants with bundle branch block. Frederica's formula (QT interval corrected using Fridericia's formula [QTcF]) should be used to calculate the corrected QT interval. If a single electrocardiogram (ECG) at screening shows QTcF > 450 msec (or > 480 msec for participants with bundle branch block), a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion.
Trial locations and contacts
19 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 9 countries
Japan3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Fukuoka, 812-8582
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hiroshima, 734-8551
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hokkaido, 060-8648
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Panama3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Panama City
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Panama City
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Panama City
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Spain3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Barcelona, 08025
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28040
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28046
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Argentina2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Buenos Aires, 1181
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Miguel de Tucumán, T4000IHE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Brazil2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Campinas, São Paulo
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
São Paulo, São Paulo, 01232-010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
France2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Bordeaux, 33000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toulouse, 31059
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Poland2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Poznan, 61-848
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Warsaw, 02-637
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Italy1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Cona, Ferrara
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Taiwan1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Taipei
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1, Open-label, Dose-escalation Study (ELEVATE-1) to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19/CD20 T-cell Engager in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- GSK5926371
- Keywords
- GSK5926371, Autoimmune rheumatic disease, Dose escalation, Systemic lupus erythematosus, Rheumatoid arthritis, Idiopathic inflammatory myopathies, Sjogren's disease
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Myositis, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK5926371Biological
GSK5926371 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation of GSK5926371 | Experimental | Not described Receives: Biological: GSK5926371 |
| Part 2: Dose Division of GSK5926371 | Experimental | Not described Receives: Biological: GSK5926371 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs)
Measured: Up to 196 days
Secondary outcomes (12)
Part 1: Maximum Observed Plasma Concentration (Cmax) After GSK5926371 Dosing
Measured: Up to 43 days
Part 2: Cmax After GSK5926371 Dosing
Measured: Up to 113 days
Part 1 and Part 2: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK5926371
Measured: Up to 196 days
Part 1 and Part 2: Titers of ADAs Against GSK5926371
Measured: Up to 196 days
Part 1: Absolute B-cell and T-cell Counts in Blood
Measured: Up to 57 days
Part 2: Absolute B-cell and T-cell Counts in Blood
Measured: Up to 196 days
Part 1: Change from Baseline in B-cell and T-cell Counts in Blood
Measured: From Baseline up to 57 days
Part 2: Change from Baseline in B-cell and T-cell Counts in Blood
Measured: From Baseline up to 196 days
Part 1 and Part 2: Change from Baseline in Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) in Blood
Measured: From Baseline up to 196 days
Part 1 and Part 2: Number of Participants with Clinically Significant Changes in Laboratory Parameters
Measured: Up to 196 days
Part 1 and Part 2: Number of Participants with Clinically Significant Changes in Vital Signs
Measured: Up to 196 days
Part 1 and Part 2: Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
Measured: Up to 196 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start10 Feb 2026
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
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.
- More trials run by GlaxoSmithKlineThe 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371468
- Sponsor's protocol ID
- 300134
- Other IDs
- 2025-522932-15-00, 2025
- Acronym
- ELEVATE-1
- Status last verified
- Jun 2026
- First submitted
- 19 Jan 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-escalation Study (ELEVATE-1) to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19/CD20 T-cell Engager in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
- ClinicalTrials.gov ID
- NCT07371468
- Acronym / sponsor ID
- ELEVATE-1 / 300134
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- GSK5926371, Autoimmune rheumatic disease, Dose escalation, Systemic lupus erythematosus, Rheumatoid arthritis, Idiopathic inflammatory myopathies, Sjogren's disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 28 Jan 2026 (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.
This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation of GSK5926371 | Experimental | Biological: GSK5926371 |
| Part 2: Dose Division of GSK5926371 | Experimental | Biological: GSK5926371 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Part 1 will enroll adult participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).
- Part 2 will enroll adult participants with SLE, RA, idiopathic inflammatory myopathies (IIM) or Sjogren's disease (SjD).
- Participants must be 18 to 70 years of age inclusive at the time of signing the informed consent form.
- Body mass index (BMI) between 18-35 kilograms per square meter (kg/m^2) inclusive with a body weight of greater than or equal to (>=) 45 kilograms (kg).
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
Key exclusion criteria (43 listed)
- Any acute, severe autoimmune disease-related flare before, or during the Screening Period (up to and including Day 1) that needs immediate treatment or is expected to require escalation of treatment to prohibited medications for the duration of the study.
- Significant allergies to humanized monoclonal antibodies or significant sensitivity to any constituents of the study drug (including excipients).
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to the autoimmune condition under study (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, or infectious diseases) and/or a planned surgical procedure, which, in the opinion of the investigator, could confound the results of the clinical study or put the participant at undue risk.
- Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data.
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 |
|---|---|---|
| GSK5926371GSK5926371 will be administered. | Biological | Part 1: Dose Escalation of GSK5926371, Part 2: Dose Division of GSK5926371 |
Primary outcome
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Up to 196 days
12 secondary outcomes
Part 1: Maximum Observed Plasma Concentration (Cmax) After GSK5926371 Dosing
Time frame: Up to 43 days
Part 2: Cmax After GSK5926371 Dosing
Time frame: Up to 113 days
Part 1 and Part 2: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK5926371
Time frame: Up to 196 days
Part 1 and Part 2: Titers of ADAs Against GSK5926371
Time frame: Up to 196 days
Part 1: Absolute B-cell and T-cell Counts in Blood
Time frame: Up to 57 days
Part 2: Absolute B-cell and T-cell Counts in Blood
Time frame: Up to 196 days
Part 1: Change from Baseline in B-cell and T-cell Counts in Blood
Time frame: From Baseline up to 57 days
Part 2: Change from Baseline in B-cell and T-cell Counts in Blood
Time frame: From Baseline up to 196 days
Part 1 and Part 2: Change from Baseline in Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) in Blood
Time frame: From Baseline up to 196 days
Part 1 and Part 2: Number of Participants with Clinically Significant Changes in Laboratory Parameters
Time frame: Up to 196 days
Part 1 and Part 2: Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to 196 days
Part 1 and Part 2: Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
Time frame: Up to 196 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
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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.
GSK Clinical Trials study director
GlaxoSmithKline
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK5926371 in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 19 sites in 9 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 10 inclusion and 43 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan, Panama, Spain, Argentina, Brazil and 4 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs) (time frame: Up to 196 days). 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 23 Jun 2026.