Long-term Belimumab Safety Study for Lung Disease in Connective Tissue Diseases
Tests belimumab long term in adults with lung scarring from connective tissue diseases.
Key facts
- Who runs it
- GlaxoSmithKline
- Where
- Poria – Neve Oved, IsraelSee the siteAlso in 10 other countries, 34 sites
- Trial code
- Registry title
- 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)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 514 people, planned
- Started
- 12 Dec 2024
- Expected to end
- 23 Oct 2030
- Type of study
- Interventional
- Treatments tested
- Belimumab
- Record updated
- 9 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lung disease linked to systemic sclerosis or another connective tissue disease who finished week 52 of one of two earlier belimumab studies (218224 or 221672) and did not stop treatment.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Interstitial lung disease (ILD) linked to systemic sclerosis (SSc) or other connective tissue diseases (CTD). Must have completed the Week 52 visit of study 218224 or 221672.
- Earlier treatment
- Must have stayed on the study medication in study 218224 or 221672 through Week 52, with no stopping for any reason.
Main reasons for not taking part
- Stopped study treatment in study 218224 or 221672 before Week 52
- New serious, unstable or uncontrolled disease not due to SSc or other CTD, or a side effect in the earlier study that puts the person at undue risk
- More than 10 mSv of ionizing radiation above background in the past 3 years
- QTc greater than 480 msec at Week 52 of the earlier study
- Pregnant or breastfeeding
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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:; Is a woman of non-childbearing potential (WONCBP) or is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percentage (%), during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention
- 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
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
- Additional requirements for pregnancy testing during and after study intervention are located
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy; 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
Who cannot take part
- Participants of study 218224 or study 221672 who have discontinued study treatment, prior to Week 52
- 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
- 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
- QT Interval Corrected (QTc) greater than (>) 480 millisecond (msec) at Week 52 of parent study 218224 or study 221672
Where in Israel
Also in 10 other countries, 34 sites
- Poria – Neve Oved, IsraelHospital not named in the registryContact: Sabbah Firas (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Participants receiving BelimumabTreatment being tested
Participants will receive belimumab.
Treatment: Belimumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Long-term Belimumab Safety Study for Lung Disease in Connective Tissue DiseasesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 September 2026