Connective Tissue Diseases study: Belimumab
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?
This is an investigational medicine being studied to see if it can help slow the loss of lung function in people with certain connective tissue diseases. It is designed to block a specific protein in the immune system called B-cell activating factor to help reduce inflammation.
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 study is looking at how safe belimumab is over a long time. It also checks if it keeps helping to slow lung damage.
- Who it's for
- You may be able to join if you have lung disease linked to systemic sclerosis or other connective tissue diseases.
- What's involved
- You would keep taking belimumab. The team will check your lung health and how you feel during visits.
- Time commitment
- The study lasts for a long time with regular check-ins to monitor your health.
- 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
- 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...
- 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...
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
- 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.
- 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 is enrolling
- Los Angeles, California, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- Ciudad Autonoma de Buenos Aire, Argentina
- Santa Fe, Argentina
- Fitzroy, Victoria, Australia
- Beijing, China
- Chengdu, China
- Hangzhou, China
- Mianyang, China
- Shanghai, China
- Shenyang, China
- Zhuzhou, China
- Toulouse, France
- Larissa, Greece
- Thessaloniki, Greece
- Poria – Neve Oved, Israel, Israel
- Aichi, Japan
+ 15 more site(s).
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, but 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?
This study is enrolling now at Los Angeles, California, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States; Buenos Aires, Argentina; Ciudad Autonoma Buenos Aires, Argentina; Ciudad Autonoma de Buenos Aire, Argentina and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.