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

Conditions

• Scleroderma, Systemic
• Systemic Sclerosis Associated Interstitial Lung Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Belimumab — BIOLOGICAL
  Belimumab will be administered.
• Placebo — OTHER
  .Placebo will be administered.

Study Details

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).

Key Dates

Start date

Sep 13, 2023

Status verified

Jan 2026

Primary completion

May 17, 2029

Completion

Jul 12, 2029

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Belimumab
  Participants will receive belimumab in addition to standard therapy.
• Placebo Comparator: Placebo
  Participants will receive placebo in addition to standard therapy.

Primary Outcome Measure

Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52 [ Time Frame: Baseline and Week 52 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (25)

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