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Belimumab Auto-Injector

Phase 2

Autoimmune Hepatitis | Monoclonal antibody | Immunology |GSK plc|Trials Updated: Oct 22, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Belimumab Auto-Injector clinical trials

Belimumab Auto-Injector · 1 trial · 1 indication

Phase 2 1
NCT06381453Belimumab in Autoimmune HepatitisAutoimmune Hepatitis
RECRUITING48 Analytics
PHASE2RECRUITING
Belimumab in Autoimmune Hepatitis
Autoimmune Hepatitis
NCT0638145348
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Study Endpoints

Primary Endpoints

To investigate the effect of treatment with Belimumab on AIH disease activity and corticosteroid use in the management of AIH
Week 48

Group A: Proportion of subjects achieving a response of ALT\<1.5x ULN and corticosteroids \</= 5mg of Prednisone (or equivalent) Group B: Proportion of subjects able to maintain remission (normal ALT, normal IgG) on monotherapy with Belimumab

Secondary Endpoints

To investigate the effects of treatment with Belimumab on AIH disease activity and treatment burden
Week 48, Week 72
To measure the effects of treatment with Belimumab on AIH disease activity and treatment burden
Week 48, Week 72
To see the effects of treatment with Belimumab on AIH disease activity and treatment burden
Week 48, Week 72
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BelimumabEXPERIMENTAL200mg subcutaneous injection once a week

Interventions

NameTypeDescription
Belimumab Auto-Injector [Benlysta]DRUGBelimumab 200 MG/ML \[Benlysta\] will be given once a week as single-dose autoinjector
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Ability to provide written informed consent * Established clinical diagnosis of autoimmune hepatitis for at least 6 months * Participant and clinician consent to follow AIH study therapy guidance for the duration of the open label clinical trial. Group A: * ALT \> 1.5 x ULN ...

Countries:Canada
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