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New treatment option for Systemic Lupus Erythematosus
Official title A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
ClinicalTrials.gov ID: NCT06576271
What this study is testing
What is GSK4527363?
GSK4527363 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 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and Japanese descent (Part C), and participants with interstitial lung disease associated with connective tissue disease (Part D)
- 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 65. Healthy volunteers may be eligible.
You may be able to join if
- For Part A and Part C (Healthy Participants):
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and...
- Part C only: Be of Japanese (Cohort C1) or Chinese (Cohort C2) ancestry i. Born in Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort...
- Body weight greater than or equals to (\>=) 45 kilograms (kg)
You likely can't join if
- For Part A and Part C (Healthy Participants):
- History or presence or cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug
- Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks before...
- Symptomatic herpes zoster within 3 months prior to screening
- Have a history of malignancy, or a strong family history of malignancies related to immunosuppression
See the full eligibility criteria
Who can join
- For Part A and Part C (Healthy Participants):
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (vital signs and 12-lead ECG)
- Part C only: Be of Japanese (Cohort C1) or Chinese (Cohort C2) ancestry i. Born in Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2); and ii. Descendent of 2 ethnic Japanese (Cohort C1) or Chinese...
- Body weight greater than or equals to (\>=) 45 kilograms (kg)
- Body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m\^2) (inclusive)
- Male or female of non-childbearing potential For Part B (SLE participants):
- 18 to 65 years of age inclusive, at the time of signing the informed consent form
- Documented clinical diagnosis of SLE according to the (European alliance of associations of rheumatology [EULAR]/ American College of Rheumatology [ACR] SLE classification criteria)
- Body weight \>= 45 kg
- BMI within the range 18-32 kg/m\^2 (inclusive)
- Male or female
- Capable of giving signed informed consent For Part D (CTD-ILD Participants)
- Participants must be 18 to 65 years of age, at the time of signing the informed consent form
- Documented clinical diagnosis of specific Connective Tissue Diseases in accordance with internationally recognised classification criteria
- Documented clinical diagnosis of interstitial lung disease (ILD) as determined by historical High-resolution computed tomography (HRCT)
- Participants must be on a stable dose of therapy to manage ILD and/or underlying connective tissue disease (CTD)
- Body weight \>= 45 kg
- BMI within the range 18-32 kg/m\^2 (inclusive)
- Male or female
- Capable of giving signed informed consent
What rules you out
- For Part A and Part C (Healthy Participants):
- History or presence or cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug
- Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks before dosing
- Symptomatic herpes zoster within 3 months prior to screening
- Have a history of malignancy, or a strong family history of malignancies related to immunosuppression
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
- Abnormal blood pressure
- Evidence of active or latent Tuberculosis (TB)
- Alanine transaminase (ALT) \>=1.1\ Upper limit of normal (ULN)
- Total bilirubin \>1.0\ ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>=1.5\ ULN as long as direct bilirubin is less than or equal to (\<=)1.5\ ULN
- Presence of Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) 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
- Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention
- Positive Human immunodeficiency virus (HIV) antibody test at screening
- Prior medical history of anaphylaxis
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec)
- Live vaccine(s) within 30 days before the dosing day or plans to receive such vaccines during the study For Part B (SLE participants):
- Any acute, severe lupus related flare during the Screening Period that needs immediate treatment
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE which, in the opinion of the principal investigator (PI), could confound the results of the clinical study or put...
- Have an acute or chronic infection requiring management as follows: i. Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical...
- Evidence of active or latent TB
- Confirmed Progressive Multifocal Leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms
- ALT \>2\ ULN
- Total bilirubin \>1.5\ ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5\ ULN as long as direct bilirubin is \>1.5\ ULN
- Presence of HBsAg and/or HBcAb 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
- Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention
- History or positive test at Screening for HIV
- QTcF \>450 msec
- 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...
- Live or live-attenuated vaccine(s) within 30 days prior to Screening For Part D Participants:
- A diagnosis of: ILD other than CTD-ILD and/or SLE
- FVC \<= 45% predicted at Screening Pulmonary arterial hypertension, as determined by the Investigator, prior to Day 1
- Major surgery (including joint surgery) within 3 months prior to Screening or planned during the duration of the study
- Previous or planned major organ transplant (e.g. heart, lung, kidney, liver) or bone marrow transplant (e.g. autologous stem cell transplant)
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to CTD-ILD (i.e., cardiovascular, metabolic, hematologic, GI, hepatic, renal, neurological, psychiatric, malignancy, or...
- Have an acute or chronic infection including requiring management
- Evidence of active or latent TB
- Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms
- ALT \>2\ ULN
- Total bilirubin \>1.5\ ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5\ ULN as long as direct bilirubin is \>1.5\ ULN
- Presence of HBsAg and/or HBcAb 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
- Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention
- History or positive test at Screening for HIV
- 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, CIN or carcinoma in situ of the cervix that have been resected with...
- Live or live-attenuated vaccine(s) within 30 days prior to Screening or plans to receive such vaccines during the Screening period or during the clinical study
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Aurora, Colorado, United States
- Las Vegas, Nevada, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Dallas, Texas, United States
- Buenos Aires, Argentina
- Rosario, Argentina
- San Juan Bautista, Argentina
- San Miguel de Tucumán, Argentina
- Porto Alegre, Rio Grande do Sul, Brazil
- Juiz de Fora, Brazil
- Porto Alegre, Brazil
- Salvador, Brazil
- Bydgoszcz, Poland
- Krakow, Poland
- Poznan, Poland
- Warsaw, Poland
- Wroclaw, Poland
- Barcelona, Spain
+ 8 more site(s).
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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Aurora, Colorado, United States; Las Vegas, Nevada, United States; Columbus, Ohio, United States; Oklahoma City, Oklahoma, United States; Dallas, Texas, United States and 22 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.