Systemic Lupus ErythematosusPhase 1NCT06576271
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
A Phase 1 study testing GSK4527363 and Belimumab in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 28 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- GSK4527363 and Belimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 2 Sep 2024to 11 Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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 (Cohort C2) parents and 4 ethnic grandparents; and iii. Have lived outside Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2) for less than 10 years at the time of screening
- 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)
Show all 22Show fewer
- 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
Who cannot join
- 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
Show all 51Show fewer
- 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 the participant at undue risk
- Have an acute or chronic infection requiring management as follows:
- Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria ii. A serious infection requiring treatment with antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed
- 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 cervix that have been resected with no evidence of metastatic disease for 3 years
- 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 infectious diseases) which, in the opinion of the PI, could confound the results of the clinical study or put the participant at undue risk
- 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 no evidence of metastatic disease for 3 years
- 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
Trial locations and contacts
28 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 6 countries
United States6 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Aurora, Colorado, 80045
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
Columbus, Ohio, 44109
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
- Withdrawn
GSK Investigational Site
Dallas, Texas, 75390
- Recruiting
GSK Investigational Site
Las Vegas, Nevada, 89154
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
- Withdrawn
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
- Withdrawn
GSK Investigational Site
Scottsdale, Arizona, 85260
Poland5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Bydgoszcz, 85-065
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
Krakow, 30-688
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
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, 02-665
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
Wroclaw, 50-556
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
Spain5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Barcelona, 08916
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
Bilbao, 48013
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
Pamplona, 31008
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
Sabadell Barcelona, 08208
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
Valladolid, 47012
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
Argentina4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Buenos Aires, C1280AEB
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
Rosario, S2002
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 Juan Bautista, B1888AAE
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
Brazil4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Juiz de Fora, 36010-570
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
Porto Alegre, Rio Grande do Sul, 90035-903
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
Porto Alegre, 90480000
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
Salvador, 40050-410
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
United Kingdom4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Cambridge, CB2 0GG
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
Liverpool, L7 8YE
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
London, SW3 6HP
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
Middlesex, HA1 3UJ
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, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)
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)
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- GSK4527363, Placebo matching GSK4527363, Belimumab
- Keywords
- Belimumab, First time in human study, GSK4527363, Healthy participants, Immunogenicity, Pharmacokinetics, Systemic lupus erythematosus, Interstitial lung disease, Connective tissue disease
- Medical subject headings
- Lupus Erythematosus, Systemic, Lung Diseases, Interstitial, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK4527363Drug
GSK4527363 will be administered to participants.
Placebo matching GSK4527363Drug
Placebo matching GSK4527363 will be administered to participants.
BelimumabDrug
Belimumab will be administered to participants.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Healthy participants receiving GSK4527363 | Experimental | Not described Receives: Drug: GSK4527363 |
| Part A: Healthy participants receiving placebo matching GSK4527363 | Placebo comparator | Not described Receives: Drug: Placebo matching GSK4527363 |
| Part A: Healthy participants receiving belimumab | Experimental | Not described Receives: Drug: Belimumab |
| Part B: Participants with SLE receiving GSK4527363 | Experimental | Not described Receives: Drug: GSK4527363 |
| Part B: Participants with SLE receiving belimumab | Experimental | Not described Receives: Drug: Belimumab |
| Part C: Healthy Japanese participants receiving GSK4527363 | Experimental | Not described Receives: Drug: GSK4527363 |
| Part C: Healthy Japanese participants receiving placebo matching GSK4527363 | Placebo comparator | Not described Receives: Drug: Placebo matching GSK4527363 |
| Part C: Healthy Chinese participants receiving GSK4527363 | Experimental | Not described Receives: Drug: GSK4527363 |
| Part C: Healthy Chinese participants receiving placebo matching GSK4527363 | Placebo comparator | Not described Receives: Drug: Placebo matching GSK4527363 |
| Part D: Participants with CTD-ILD receiving GSK4527363 | Experimental | Not described Receives: Drug: GSK4527363 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Measured: Up to Week 52
Parts B and D: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Measured: Up to Week 68
Parts A and C: Number of Participants with Clinically Significant Changes in Physical Examination, Laboratory Parameters, Vital Signs, and 12 lead Electrocardiogram (ECG) Findings
Measured: Up to Week 52
Parts B and D: Number of Participants with Clinically Significant Changes in Physical Examination, Laboratory Parameters, Vital Signs, and 12 lead Electrocardiogram (ECG) Findings
Measured: Up to Week 68
Parts A and C: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score >0.
Measured: Up to Week 52
Parts B, and D: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score >0.
Measured: Up to Week 68
Secondary outcomes (12)
Parts A and C: Area Under the Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-t]) of GSK4527363
Measured: Up to Week 52
Parts A and C: Area Under the Concentration-time Curve to Infinity (AUC[0-inf]) of GSK4527363
Measured: Up to Week 52
Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363
Measured: Up to Week 52
Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363
Measured: Up to Week 52
Parts A and C: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Measured: Up to Week 52
Parts B and D: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Measured: Up to Week 68
Parts A, B and C: Titers of ADAs Against GSK4527363
Measured: Up to Week 52
Parts A and C: Percentage change from Baseline in cytokine levels
Measured: Baseline (Day 1) and up to Week 52
Parts B and D: Percentage change from Baseline in cytokine levels
Measured: Baseline (Day 1) and up to Week 68
Part B and D: Area Under the Concentration-time Curve of GSK4527363
Measured: Up to Week 12
Part B and D: Maximum Plasma Concentration of GSK4527363
Measured: Up to Week 12
Part B and D: Concentration at the end of the First Dosing Interval of GSK4527363
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start2 Sep 2024
- Primary completion11 Jan 2028 (estimated)
- Study completion11 Jan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 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
- NCT06576271
- Sponsor's protocol ID
- 221458
- Other IDs
- 2024-514186-18-00
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)
- ClinicalTrials.gov ID
- NCT06576271
- Acronym / sponsor ID
- 221458
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Belimumab, First time in human study, GSK4527363, Healthy participants, Immunogenicity, Pharmacokinetics, Systemic lupus erythematosus, Interstitial lung disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 11 Jan 2028 (estimated)
- Study completion
- 11 Jan 2028 (estimated)
- First posted
- 28 Aug 2024 (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 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A: Healthy participants receiving GSK4527363 | Experimental | Drug: GSK4527363 |
| Part A: Healthy participants receiving placebo matching GSK4527363 | Placebo comparator | Drug: Placebo matching GSK4527363 |
| Part A: Healthy participants receiving belimumab | Experimental | Drug: Belimumab |
| Part B: Participants with SLE receiving GSK4527363 | Experimental | Drug: GSK4527363 |
| Part B: Participants with SLE receiving belimumab | Experimental | Drug: Belimumab |
| Part C: Healthy Japanese participants receiving GSK4527363 | Experimental | Drug: GSK4527363 |
| Part C: Healthy Japanese participants receiving placebo matching GSK4527363 | Placebo comparator | Drug: Placebo matching GSK4527363 |
| Part C: Healthy Chinese participants receiving GSK4527363 | Experimental | Drug: GSK4527363 |
| Part C: Healthy Chinese participants receiving placebo matching GSK4527363 | Placebo comparator | Drug: Placebo matching GSK4527363 |
| Part D: Participants with CTD-ILD receiving GSK4527363 | Experimental | Drug: GSK4527363 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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 (Cohort C2) parents and 4 ethnic grandparents; and iii. Have lived outside Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2) for less than 10 years at the time of screening
- 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)
Key exclusion criteria (51 listed)
- 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
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 |
|---|---|---|
| GSK4527363GSK4527363 will be administered to participants. | Drug | Part A: Healthy participants receiving GSK4527363, Part B: Participants with SLE receiving GSK4527363, Part C: Healthy Chinese participants receiving GSK4527363, Part C: Healthy Japanese participants receiving GSK4527363, Part D: Participants with CTD-ILD receiving GSK4527363 |
| Placebo matching GSK4527363Placebo matching GSK4527363 will be administered to participants. | Drug | Part A: Healthy participants receiving placebo matching GSK4527363, Part C: Healthy Chinese participants receiving placebo matching GSK4527363, Part C: Healthy Japanese participants receiving placebo matching GSK4527363 |
| BelimumabBelimumab will be administered to participants. | Drug | Part A: Healthy participants receiving belimumab, Part B: Participants with SLE receiving belimumab |
Primary outcome
Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Time frame: Up to Week 52
Parts B and D: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Time frame: Up to Week 68
Parts A and C: Number of Participants with Clinically Significant Changes in Physical Examination, Laboratory Parameters, Vital Signs, and 12 lead Electrocardiogram (ECG) Findings
Time frame: Up to Week 52
Parts B and D: Number of Participants with Clinically Significant Changes in Physical Examination, Laboratory Parameters, Vital Signs, and 12 lead Electrocardiogram (ECG) Findings
Time frame: Up to Week 68
Parts A and C: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 52
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score >0.
Parts B, and D: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 68
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score >0.
12 secondary outcomes
Parts A and C: Area Under the Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-t]) of GSK4527363
Time frame: Up to Week 52
Parts A and C: Area Under the Concentration-time Curve to Infinity (AUC[0-inf]) of GSK4527363
Time frame: Up to Week 52
Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363
Time frame: Up to Week 52
Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363
Time frame: Up to Week 52
Parts A and C: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Time frame: Up to Week 52
Parts B and D: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Time frame: Up to Week 68
Parts A, B and C: Titers of ADAs Against GSK4527363
Time frame: Up to Week 52
Parts A and C: Percentage change from Baseline in cytokine levels
Time frame: Baseline (Day 1) and up to Week 52
Parts B and D: Percentage change from Baseline in cytokine levels
Time frame: Baseline (Day 1) and up to Week 68
Part B and D: Area Under the Concentration-time Curve of GSK4527363
Time frame: Up to Week 12
Part B and D: Maximum Plasma Concentration of GSK4527363
Time frame: Up to Week 12
Part B and D: Concentration at the end of the First Dosing Interval of GSK4527363
Time frame: Up to Week 12
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 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.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
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK4527363 and Belimumab in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 28 sites in 6 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 22 inclusion and 51 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 22 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 28 sites in United States, Poland, Spain, Argentina, Brazil and 1 more country. 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. Some participants in this study may receive a placebo. 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?
Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events (time frame: Up to Week 52). The study lists 6 primary outcomes in all. 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 22 Jun 2026.