A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

Conditions

• Lung Diseases, Interstitial

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

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

Key Dates

Start date

Sep 11, 2024

Status verified

Mar 2026

Primary completion

Oct 18, 2028

Completion

Dec 13, 2028

Study Design

Enrollment

440 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) milliliter (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 (16)

Find similar trials in Los Angeles, CA

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