BridgeMD
New treatment option for Systemic Lupus Erythematosus
Official title A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
ClinicalTrials.gov ID: NCT07371468
What this study is testing
What is GSK5926371?
GSK5926371 is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
You likely can't join if
- Any acute, severe autoimmune disease-related flare before, or during the Screening Period (up to and including Day 1) that needs immediate treatment...
- 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...
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to the autoimmune condition under study (i.e...
- Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the...
- Participant has a diagnosis of primary or acquired immunodeficiency, except for selective IgA deficiency.
See the full eligibility criteria
Who can 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
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- Participant has a diagnosis of primary or acquired immunodeficiency, except for selective IgA deficiency.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Small molecule inhibitors, including tyrosine kinase 2 inhibitor (TYK2i, Deucravacitinib); inhibitors of Janus kinases (JAKis, baricitinib, tofacitinib, upadacitinib, filgotinib); or Bruton tyrosine kinase inhibitors...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Argentina
- San Miguel de Tucumán, Argentina
- Campinas, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Bordeaux, France
- Toulouse, France
- Cona, Ferrara, Italy
- Fukuoka, Japan
- Hiroshima, Japan
- Hokkaido, Japan
- Panama City, Panama
- Poznan, Poland
- Warsaw, Poland
- Barcelona, Spain
- Madrid, Spain
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Argentina; San Miguel de Tucumán, Argentina; Campinas, São Paulo, Brazil; São Paulo, São Paulo, Brazil; Bordeaux, France; Toulouse, France and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.