An open label study to investigate the long-term safety and efficacy of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD)
Recipient organisationNIHR Royal Free Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Ongoing
In plain English
AI plain-English summary
Patients who completed a prior trial of the drug belimumab for a severe lung-scarring condition will receive weekly injections for up to five years to test long-term safety and effectiveness. This matters because systemic sclerosis—a rare autoimmune disease that hardens the skin and internal organs—often leads to interstitial lung disease (SSc-ILD), a progressive scarring of the lungs that is a leading cause of death in these patients. The parent trial tested belimumab, an antibody that blocks a key immune protein, but long-term data are lacking. This open-label extension study gives all eligible participants the active drug, regardless of what they received before, and tracks them for roughly five years plus an eight-week safety follow-up. If belimumab proves safe and effective over the long term, it could become a standard treatment option for SSc-ILD, potentially slowing lung decline and improving survival. Because the condition is rare and debilitating, even a modest benefit would change clinical practice. The study also generates real-world safety data that regulators and clinicians need before approving the drug for this specific use.
View original technical description
This is an OLE study to evaluate the long-term safety and efficacy of belimumab administered SC in eligible adult participants with interstitial lung disease associated with diffuse cutaneous systemic sclerosis (dcSSc-ILD) who have completed study 218224, that in the opinion of the investigator may benefit from treatment and have provided consent to join the OLE study. All eligible participants who choose to join the OLE study will receive SC belimumab 200mg per week via an autoinjector regardless of treatment allocation in the parent study. The Week 52 visit in the parent study 218224 will be considered the first visit of the OLE study 219855 and will include the first administration of open label belimumab. The blinding of study treatment allocation in parent study 218224 will be maintained until the parent study has been analyzed or reported. The OLE study will have approximately 5 years of treatment period and an 8-week safety follow-up period following discontinuation of study treatment. The study treatment duration may be changed if necessary e.g., to align with revised commercial availability, or if an alternative early access (or equivalent) program is started, or if development of belimumab in SSc-ILD is stopped/re-evaluated. Additionally, after the parent study 218224 completes and is analyzed or reported, or if in the opinion of the parent study IDMC it is appropriate from a data driven benefit-risk profile perspective, some visits may become optional at principal investigator’s discretion. They remain mandatory until that time. When study treatment with belimumab is discontinued, participants will be asked to attend a safety follow-up visit, 8 weeks after their last study treatment with belimumab administration. When belimumab becomes licensed and commercially available or an alternative access program is initiated in a country, participants in that country will proceed as follows.
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