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Long-term Study of Belimumab for Lung Disease in Connective Tissue Diseases

This study is looking at the long-term safety and effectiveness of a medicine called belimumab. It's for adults who have interstitial lung disease (ILD), which is a type of lung scarring, linked to systemic sclerosis (SSc) or other connective tissue diseases (CTD). You can join this study if you've already completed a related study (218224 or 221672) and didn't stop treatment early. The main goal is to see how well belimumab is tolerated over time, and if it continues to help slow down lung function decline, overall disease progression, and improve your quality of life. The study plans to enroll 514 participants, but its current status is unclear.

Study design
This is an open-label extension study, meaning everyone knows they are receiving belimumab. It's a continuation of two previous studies and plans to include 514 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety events for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06716606

A 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) (BLISSconneCTD-OLE)

Recruiting
PHASE3Ages 18+InterventionalTreatment
GlaxoSmithKline
~514 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Belimumab

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Adverse events (AEs), Adverse Event of Special Interest events (AESIs), and Serious Adverse Event (SAEs)
Measured over Up to approximately 5 years

Conditions

Connective Tissue Diseases

Explore related trials

Connective Tissue DisorderInterstitial Lung DiseaseSystemic Scleroderma

Where it's being run

10 sites across 7 states
Argentina2
China2
Japan2
Pennsylvania1
Greece1
South Korea1
United Kingdom1

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224 or 221672 through to and including the Week 52 visit and are not considered treatment failure, defined as meeting either of the following criteria:
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.
Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

Exclusion

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.
QT Interval Corrected (QTc) greater than (\>) 480 millisecond (msec) at Week 52 of parent study 218224 or study 221672.

What this trial measures

  • Number of participants with Adverse events (AEs), Adverse Event of Special Interest events (AESIs), and Serious Adverse Event (SAEs)Up to approximately 5 years