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A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Study acronym: BLISSc-ILD
StatusRecruiting
PhasePhase 2/3
Started2023-09-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later May 17, 2029 → Aug 30, 2029
See other at-risk trials from GlaxoSmithKline

Amendment history

2026-09-04
Study Status, Contacts/Locations v16
Trial sites expanded: 131 → 134 locations
Primary completion pushed: 2029-05-17 → 2029-08-30
Completion pushed: 2029-07-12 → 2029-10-25
2026-01-09
Study Status, Contacts/Locations v15
Primary completion date2027-05-17→2029-05-17
Completion date2027-07-12→2029-07-12
Study sites130→131
2025-09-24
Study Status, Contacts/Locations v14
Study sites128→130
2025-08-05
Study Status v13
Re-verified, no change to tracked fields
2025-07-07
Study Status, Contacts/Locations v12
Study sitescontacts updated at 2 of 128 sites
Show 11 earlier versions
2025-06-09
Study Identification, Study Status, Contacts/Locations v11
Study sites126→128
2025-04-28
Study Status, Contacts/Locations v10
Study sites124→126
2025-03-28
Study Status, Study Design, Contacts/Locations v9
PhasePhase 3→Phase 2/3
Study sites123→124
2025-02-27
Study Status, Contacts/Locations v8
Primary completion date2027-07-12→2027-05-17
Study sites122→123
2025-01-17
Study Status, Study Design, Contacts/Locations v7
PhasePhase 2/3→Phase 3
Study sites119→122
2024-12-02
Study Identification, Study Status, Contacts/Locations v6
Study sites135→119
2024-10-22
Study Status, Study Design, Contacts/Locations v5
PhasePhase 3→Phase 2/3
Primary completion date2027-02-15→2027-07-12
Completion date2027-02-15→2027-07-12
Study sites128→135
2024-01-03
Study Identification, Study Status, Study Design, Outcome Measures v4
PhasePhase 2/3→Phase 3
Secondary endpointsdetails revised at 1 of 22 entries
Study title-28 characters
A Study of the EfficiencyEfficacy Andand Safety Study of Belimumab Compared To Placebo Inin Adults With Systemic Sclerosis Associated Interstitial Lung Disease
2023-11-16
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
PhasePhase 3→Phase 2/3
Start dateestimated 2023-09-29→confirmed 2023-09-13
Secondary endpoints21 to 22 entries
Absolute change from baseline in DLco % predicted at Week 52
Study sitesdetails revised at 128 of 128 sites
Study title+28 characters
A Study of the EfficacyEfficiency andAnd Safety Study of Belimumab inCompared To Placebo In Adults With Systemic Sclerosis Associated Interstitial Lung Disease
2023-09-25
Study Status, Conditions, Study Design, Contacts/Locations v2
PhasePhase 2/3→Phase 3
Primary completion date2026-10-28→2027-02-15
Completion date2027-02-03→2027-02-15
Start date2023-08-18→2023-09-29
Study sites0→128
2023-07-17
Study Identification, Study Status v1
Start date2023-05-17→2023-08-18
Study title-28 characters
A Study of the EfficiencyEfficacy Andand Safety Study of Belimumab Compared To Placebo Inin Adults With Systemic Sclerosis Associated Interstitial Lung Disease
2023-05-19
Original filing
GlaxoSmithKline
238 trials monitored
See 18 trials at risk
Scleroderma
302 trials monitored
See 9 trials at risk
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
Trial Details
NCT Number NCT05878717
Lead Sponsor GlaxoSmithKline
Conditions Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
Enrollment 300 participants
Start Date 2023-09-13
Primary Completion 2029-08-30 (estimated)
Study Completion 2029-10-25 (estimated)
Updated on ClinicalTrials.gov 2026-09-08