A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants

NCT06576271 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2214582024-514186-18-00
• Study Type: interventional
• Target: 142
• Locations: 6 countries
• Sites: 27

Brief 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 connective tissue disease (Part D)

Conditions

Systemic Lupus Erythematosus

Keywords

Belimumab; First time in human study; GSK4527363; Healthy participants; Immunogenicity; Pharmacokinetics; Systemic lupus erythematosus; Interstitial lung disease; Connective tissue disease

Outcome Measures

Primary Outcomes (6)

• Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events

  Up to Week 52

• Parts B and D: Number of Participants with Non-serious Adverse Events and Serious Adverse Events

  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

  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

  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.

  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.

  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

  Up to Week 52

• Parts A and C: Area Under the Concentration-time Curve to Infinity (AUC[0-inf]) of GSK4527363

  Up to Week 52

• Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363

  Up to Week 52

• Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363

  Up to Week 52

• Parts A and C: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363

  Up to Week 52

Study Arms (10)

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

Interventions

GSK4527363 DRUG

GSK4527363 will be administered to participants.

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 GSK4527363 DRUG

Placebo matching GSK4527363 will be administered to participants.

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

Belimumab DRUG

Belimumab will be administered to participants.

Part A: Healthy participants receiving belimumab; Part B: Participants with SLE receiving belimumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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)
• Male or female of non-childbearing potential
• For Part B (SLE participants):
• 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

You may not qualify 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 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (27)

GSK Investigational Site

Scottsdale, Arizona, 85260, United States

WITHDRAWN

GSK Investigational Site

Aurora, Colorado, 80045, United States

RECRUITING

GSK Investigational Site

Las Vegas, Nevada, 89154, United States

RECRUITING

GSK Investigational Site

Columbus, Ohio, 44109, United States

RECRUITING

GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

GSK Investigational Site

Dallas, Texas, 75390, United States

WITHDRAWN

GSK Investigational Site

Buenos Aires, C1280AEB, Argentina

RECRUITING

GSK Investigational Site

Rosario, S2002, Argentina

RECRUITING

GSK Investigational Site

San Juan Bautista, B1888AAE, Argentina

RECRUITING

GSK Investigational Site

San Miguel de Tucumán, T4000IHE, Argentina

RECRUITING

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

GSK Investigational Site

Juiz de Fora, 36010-570, Brazil

RECRUITING

GSK Investigational Site

Porto Alegre, 90480000, Brazil

RECRUITING

GSK Investigational Site

Salvador, 40050-410, Brazil

RECRUITING

GSK Investigational Site

Bydgoszcz, 85-065, Poland

RECRUITING

GSK Investigational Site

Krakow, 30-688, Poland

RECRUITING

GSK Investigational Site

Poznan, 61-848, Poland

RECRUITING

GSK Investigational Site

Warsaw, 02-665, Poland

RECRUITING

GSK Investigational Site

Wroclaw, 50-556, Poland

RECRUITING

GSK Investigational Site

Barcelona, 08916, Spain

RECRUITING

GSK Investigational Site

Bilbao, 48013, Spain

RECRUITING

GSK Investigational Site

Pamplona, 31008, Spain

RECRUITING

GSK Investigational Site

Sabadell Barcelona, 08208, Spain

RECRUITING

GSK Investigational Site

Valladolid, 47012, Spain

RECRUITING

GSK Investigational Site

Cambridge, CB2 0GG, United Kingdom

RECRUITING

GSK Investigational Site

Liverpool, L7 8YE, United Kingdom

RECRUITING

GSK Investigational Site

Middlesex, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lung Diseases, Interstitial; Connective Tissue Diseases

Interventions

belimumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): January 11, 2028
• Study Completion (Estimated): January 11, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (6); ES (5); GB (3); PL (5); AR (4); BR (4)