GSK4527363 for Lupus
Recruiting at 19 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: GlaxoSmithKline
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), and healthy participants of Chinese and Japanese descent (Part C)
Who Is on the Research Team?
GC
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for healthy individuals and those with active Systemic Lupus Erythematosus (SLE). Participants must have a BMI of 18-32 kg/m^2, weigh at least 45 kg, and not be able to bear children. Part C specifically requires participants of Chinese or Japanese descent who haven't lived outside their country for more than 10 years.Inclusion Criteria
I am of Japanese or Chinese descent, born there, with all my parents and grandparents being ethnically the same, and have lived outside of these countries for less than 10 years.
My BMI is between 18 and 32.
I have been diagnosed with SLE by a doctor.
See 5 more
What Are the Treatments Tested in This Trial?
Interventions
- Belimumab
- GSK4527363
Trial Overview The study tests GSK4527363's safety and effects in different groups: healthy people, SLE patients, and healthy individuals of Chinese/Japanese ancestry. It compares the new drug against Belimumab and a placebo to see how it's tolerated and how it affects the body.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C: Healthy Japanese participants receiving GSK4527363Experimental Treatment1 Intervention
Group II: Part C: Healthy Chinese participants receiving GSK4527363Experimental Treatment1 Intervention
Group III: Part B: Participants with SLE receiving belimumabExperimental Treatment1 Intervention
Group IV: Part B: Participants with SLE receiving GSK4527363Experimental Treatment1 Intervention
Group V: Part A: Healthy participants receiving belimumabExperimental Treatment1 Intervention
Group VI: Part A: Healthy participants receiving GSK4527363Experimental Treatment1 Intervention
Group VII: Part C: Healthy Chinese participants receiving placebo matching GSK4527363Placebo Group1 Intervention
Group VIII: Part A: Healthy participants receiving placebo matching GSK4527363Placebo Group1 Intervention
Group IX: Part C: Healthy Japanese participants receiving placebo matching GSK4527363Placebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
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Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
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