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New lupus drug candidate enters first human tests

NCT ID NCT06576271

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new drug called GSK4527363 in healthy volunteers and people with active lupus or lupus-related lung disease. The main goal is to check safety and how the body handles the drug. Around 142 participants will take part across four groups, including people of Chinese and Japanese descent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GSK4527363
What this could lead to
If this early trial shows the drug is safe, it could lead to a new treatment option for people with lupus and related lung disease.
What could go wrong
This is a very early Phase 1 study with only 142 participants. The drug may not be safe or effective, and many early-stage drugs never make it to approval.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 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 Exclusion criteria: 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    WITHDRAWN

    Scottsdale, Arizona, 85260, United States

  • GSK Investigational Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • GSK Investigational Site

    RECRUITING

    Las Vegas, Nevada, 89154, United States

  • GSK Investigational Site

    RECRUITING

    Columbus, Ohio, 44109, United States

  • GSK Investigational Site

    WITHDRAWN

    Oklahoma City, Oklahoma, 73104, United States

  • GSK Investigational Site

    WITHDRAWN

    Dallas, Texas, 75390, United States

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1280AEB, Argentina

  • GSK Investigational Site

    RECRUITING

    Rosario, S2002, Argentina

  • GSK Investigational Site

    RECRUITING

    San Juan Bautista, B1888AAE, Argentina

  • GSK Investigational Site

    RECRUITING

    San Miguel de Tucumán, T4000IHE, Argentina

  • GSK Investigational Site

    RECRUITING

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

  • GSK Investigational Site

    RECRUITING

    Juiz de Fora, 36010-570, Brazil

  • GSK Investigational Site

    RECRUITING

    Porto Alegre, 90480000, Brazil

  • GSK Investigational Site

    RECRUITING

    Salvador, 40050-410, Brazil

  • GSK Investigational Site

    RECRUITING

    Bydgoszcz, 85-065, Poland

  • GSK Investigational Site

    RECRUITING

    Krakow, 30-688, Poland

  • GSK Investigational Site

    RECRUITING

    Poznan, 61-848, Poland

  • GSK Investigational Site

    RECRUITING

    Warsaw, 02-665, Poland

  • GSK Investigational Site

    RECRUITING

    Wroclaw, 50-556, Poland

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08916, Spain

  • GSK Investigational Site

    RECRUITING

    Bilbao, 48013, Spain

  • GSK Investigational Site

    RECRUITING

    Pamplona, 31008, Spain

  • GSK Investigational Site

    RECRUITING

    Sabadell Barcelona, 08208, Spain

  • GSK Investigational Site

    RECRUITING

    Valladolid, 47012, Spain

  • GSK Investigational Site

    RECRUITING

    Cambridge, CB2 0GG, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Liverpool, L7 8YE, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, SW3 6HP, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Middlesex, HA1 3UJ, United Kingdom

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