This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the decline in lung function in participants with interstitial lung disease associated with diffuse cutaneous systemic sclerosis (dcSSc-ILD) and interstitial lung disease associated with other connective tissue diseases (CTD-ILD), respectively. The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.
Discontinuation of study medication during study 218224 or 221672 for any reason.
Participants with SSc should have an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow subcutaneous (SC) injection at the abdomen or the front, middle region of the thigh.
Participant is capable and willing to self-administer the study medication or has a caregiver/healthcare professional who is capable and willing to administer the study medication throughout the study.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention.
Participants of study 218224 or study 221672 who have discontinued study treatment, prior to Week 52.
Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SSc or other CTD (i.e, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in study 218224 or study 221672 that could, in the opinion of the principal investigator, put the participant at undue risk.
Participants who have developed any other medical diseases (eg, cardiopulmonary), laboratory abnormalities, or conditions (eg, poor venous access) that, in the opinion of the investigator could significantly alter the absorption, metabolism, or elimination of drugs; constitutes a risk when taking the study intervention; interferes with the interpretation of data; or it is not safe for the participant to continue on the study.
Participants who have been exposed to ionizing radiation in excess of 10 millisievert (mSv) above background over the previous 3 year period as a result of occupational exposure or previous participation in research studies.
GlaxoSmithKline
Lead sponsor
ICON plc
Collaborator