W Polsce: Rekrutacja zakończonaNa świecie: RekrutujeFaza I
Toczeń: badanie fazy I leku GSK4527363 i belimumab
Badanie z GSK4527363 u zdrowych uczestników, uczestników z toczniem rumieniowatym układowym (TRU), zdrowych uczestników pochodzenia chińskiego i japońskiego i uczestników ze śródmiąższową chorobą płuc związaną z chorobą tkanki łącznej (CTD-ILD).
Tytuł w rejestrze:A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
Stan w Polsce: rekrutacja zakończona. Rekrutacja do tego badania w Polsce nie jest teraz prowadzona, ale trwa w innych krajach. Sprawdź podobne badania poniżej albo zapytaj nas o inne możliwości.
Stan rekrutacji pochodzi z rejestrów badań i może się zmienić szybciej, niż zaktualizuje go sponsor. Nasz doradca sprawdzi aktualny stan w wybranym ośrodku. Nie publikujemy nazwisk lekarzy ani ich danych kontaktowych.
Cel badania
Opis z rejestru (w języku angielskim):
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)
Leczenie w badaniu
Lek / interwencja
Rola
Postać, podanie
GSK4527363
Lek
Placebo matching GSK4527363
Lek
Belimumab
Lek
Kryteria udziału
Kryteria w języku angielskim, tak jak w rejestrze.
Kryteria włączenia kto może wziąć udział (21)
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):
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
Kryteria wyłączenia kto nie może wziąć udziału (49)
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 the participant at undue risk
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 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
To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.
Zapytaj o podobne badania
Zadzwoń, a nasz doradca ds. badań sprawdzi z Tobą wstępnie kryteria i pomoże skontaktować się z ośrodkiem. Kwalifikację zawsze przeprowadza lekarz w ośrodku. Udział w badaniu jest bezpłatny i dobrowolny.
Informacje pochodzą z publicznych rejestrów badań klinicznych (CTIS - Unia Europejska, ClinicalTrials.gov - USA) i są aktualizowane codziennie. Mogą różnić się od aktualnego stanu w ośrodku. Ostateczną kwalifikację do badania zawsze przeprowadza lekarz w ośrodku badawczym. Stan na 2 października 2026.