A Phase 2/3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD)

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503219-14-01

Acronym

218224

Enrollment

123

Registered

2024-03-04

Start date

2024-05-22

Completion date

Unknown

Last updated

2025-08-13

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

Conditions

systemic sclerosis associated interstitial lung disease

Brief summary

Absolute change from baseline in FVC (mL) at Week 52.

Detailed description

1. Absolute change from baseline in mRSS at Week 52. 2. Absolute change from baseline in FACIT-Fatigue score at Week 52. 3. Time to SSc progression or death.

Interventions

DRUGPlacebo for Belimumab Solution for Injection

DRUG200 mg/mL

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in FVC (mL) at Week 52.	—

Secondary

Measure	Time frame
1. Absolute change from baseline in mRSS at Week 52. 2. Absolute change from baseline in FACIT-Fatigue score at Week 52. 3. Time to SSc progression or death.	—

Countries

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

Outcome results

None listed

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