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Tests treatment safety and results for Connective Tissue Diseases
Official 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)
ClinicalTrials.gov ID: NCT06716606
What this study is testing
What is Belimumab?
Belimumab is an investigational medicine, being studied as a potential treatment for connective tissue diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Participant is capable and willing to self-administer the study medication or has a caregiver/healthcare professional who is capable and willing to...
- Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions...
You likely can't join if
- 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...
- Participants who have developed any other medical diseases (eg, cardiopulmonary), laboratory abnormalities, or conditions (eg, poor venous access)...
- Participants who have been exposed to ionizing radiation in excess of 10 millisievert (mSv) above background over the previous 3 year period as a...
- QT Interval Corrected (QTc) greater than (\>) 480 millisecond (msec) at Week 52 of parent study 218224 or study 221672.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- QT Interval Corrected (QTc) greater than (\>) 480 millisecond (msec) at Week 52 of parent study 218224 or study 221672.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- Ciudad Autonoma Buenos Aires, Argentina
- Ciudad Autonoma de Buenos Aire, Argentina
- Beijing, China
- Zhuzhou, China
- Larissa, Greece
- Hokkaido, Japan
- Tokyo, Japan
- Yongsan-Ku Seoul, South Korea
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; Ciudad Autonoma Buenos Aires, Argentina; Ciudad Autonoma de Buenos Aire, Argentina; Beijing, China; Zhuzhou, China; Larissa, Greece and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.