BridgeMD
A study of the efficacy and safety of belimumab compared to placebo in adults with systemic sclerosis-associated interstitial lung disease.
EU CTIS ID: 2023-503219-14-01
What this study is testing
To evaluate the efficacy of belimumab compared to placebo, in addition to standard therapy, on reducing the decline in lung volume in participants with dcSSc-ILD, as measured by change from baseline in FVC.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 18 years of age or old1. 18 years of age or older. 2. Documented diagnosis of SSc as defined by the ACR/EULAR 2013 SSc classification criteria. 3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas. 4. Presence of interstitial lung disease. 5. Evidence for active or progressive disease 6. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh. 7. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study. 8. 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 WONCBP as defined in Appendix 4: Contraceptive and Barrier Guidance. OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%. 9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.er. 2. Documented diagnosis of SSc as defined by the ACR/EULAR 2013 SSc classification criteria. 3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas. 4. Presence of interstitial lung disease. 5. Evidence for active or progressive disease 6. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh. 7. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study. 8. 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 WONCBP as defined in Appendix 4: Contraceptive and Barrier Guidance. OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%. 9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
You likely can't join if
- 1. Systemic sclerosis-like illness. 2. Pulmonary arterial hypertension. 3. SSc renal crisis within 6 months . 4. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. 5. Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC <0.7). 6. Significant allergies to human or murine proteins, humanized monoclonal antibodies, or contrast agents. 7. Clinically significant multiple or severe drug allergies. 8. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. 9. Breast cancer within the past 10 years. 10. ALT>2 x ULN. 11. Total bilirubin >1.5 x ULN (isolated total bilirubin >1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%). 12. Cirrhosis or current unstable liver or biliary disease. 13. QTc >450 msec or QTc >480 msec in participants with bundle branch block. 14. Major surgery (including joint surgery) within 3 months or planned during the duration of the study. 15. An active infection, or a history of serious infections 16. Symptomatic herpes zoster within 3 months. 17. Confirmed diagnosis of active TB or untreated latent TB infection. 18. Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms. 19. Participants with PHQ-9 score ≥10 that in the opinion of a mental healthcare professional pose a serious suicide risk, or have any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, pose a significant suicide risk. 20. Previous or planned major organ transplant. 21. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months. 22. Live vaccine(s) within 30 days or plans to receive such vaccines during the study. 23. Positive HIV antibody test. 24. Serologic evidence of Hepatitis B infection based on the results of testing for HBsAg, Anti-HBc and Anti-HBs as follows: • Patients positive for HBsAg are excluded. • Patients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require clarification of their status by testing for HBV DNA. o if HBV DNA is detectable, patients will be excluded from participation. o if HBV DNA is not detectable, patients will be eligible to enroll. 25. Positive hepatitis C antibody . 26. History of a primary immunodeficiency, or hypogammaglobulinaemia (IgG <400 mg/dL), or IgA deficiency (IgA <10 mg/dL). 27. Have a Grade 3 or greater neutropenia, defined as absolute neutrophil count <1000/mm3 (<1.0x10e9/L) based on the CTCAE v5.0.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Korea, Republic of
- Argentina
- Israel
- United Kingdom
- Japan
- Mexico
- China
- Brazil
- United States
- Canada
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Korea, Republic of; Argentina; Israel; United Kingdom; Japan and 5 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 EU CTIS; the study team decides eligibility.