An open-label study to investigate the long-term safety and efficacy of belimumab in adults with interstitial lung disease (ILD) associated with systemic sclerosis (SSc) and other connective tissue diseases (CTD)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509370-39-00

Acronym

219855

Enrollment

158

Registered

2025-01-16

Start date

2025-06-03

Completion date

Unknown

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

connective tissue diseases

Brief summary

Incidence of AEs, AESIs and SAEs

Detailed description

Absolute change from baseline* in FVC (mL) at OLE Weeks 12, 26 and 52.

Interventions

DRUGBenlysta 200 mg solution for injection in pre-filled pen.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Absolute change from baseline* in FVC (mL) at OLE Weeks 12, 26 and 52.	—

Primary

Measure	Time frame
Incidence of AEs, AESIs and SAEs	—

Countries

Belgium, Denmark, Finland, France, Germany, Greece, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026