BridgeMD
A study of different investigational treatments in people with the interstitial lung disease that accompanies scleroderma (CONQUEST)
EU CTIS ID: 2023-507129-40-00
What this study is testing
to evaluate the efficacy of the investigational products compared with placebo on the change from baseline to the end of the treatment period at Week 52 in forced vital capacity (FVC) (mL), measured in study participants with SSc-ILD
- Therapeutic exploratory (Phase II)
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
- Male or female ≥18 years of age at the time of signed informed consent.
- SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible.
- Onset of SSc (defined by first non-Raynaud’s symptom) ≤7 years prior to the Screening Visit;
- A modified Rodnan skin score (mRSS) of less than 40;
- Presence of ILD with evidence of any fibrosis on HRCT (within ≤3 months of randomization)
- Presence of an FVC ≥45% predicted normal
You likely can't join if
- Scleroderma related: Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active TB, sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);
- Other protocol and subprotocol-defined criteria apply.
- Prior treatment: History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
- Fertility: Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study;
- Liver: History of Child-Pugh Class B or Class C liver disease or presence of acute or chronic congestive heart failure ;
- Laboratory abnormalities: Presence of abnormal laboratory findings at the Screening Visit:
See the full eligibility criteria
- Male or female ≥18 years of age at the time of signed informed consent.
- SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible.
- Onset of SSc (defined by first non-Raynaud’s symptom) ≤7 years prior to the Screening Visit;
- A modified Rodnan skin score (mRSS) of less than 40;
- Presence of ILD with evidence of any fibrosis on HRCT (within ≤3 months of randomization)
- Presence of an FVC ≥45% predicted normal
- Presence of a diffusing capacity of the lung for carbon monoxide ≥30% predicted normal, corrected for hemoglobin
- Other protocol and subprotocol defined criteria apply.
- Scleroderma related: Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active TB, sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);
- Other protocol and subprotocol-defined criteria apply.
- Prior treatment: History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
- Fertility: Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study;
- Liver: History of Child-Pugh Class B or Class C liver disease or presence of acute or chronic congestive heart failure ;
- Laboratory abnormalities: Presence of abnormal laboratory findings at the Screening Visit:
- Bleeding risk: History of major trauma or hemorrhage within 30 days of the Screening Visit;
- Bleeding risk: History of any clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of the Screening Visit;
- Cardiovascular: History of any cerebrovascular events, myocardial infarction or unstable angina, restrictive or congestive cardiomyopathy (other than mild), life-threatening cardiac arrhythmias, hemodynamically significant aortic or mitral valve disease, pulmonary veno-occlusive disease. Presence of acute or chronic congestive heart failure, severe uncontrolled hypertension at the Screening Visit.
- Scleroderma related: History of scleroderma renal crisis within 6 months prior to the Screening Visit.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Switzerland
- Malaysia
- Australia
- China
- Argentina
- Japan
- United Kingdom
- United States
- Israel
- Taiwan
- Thailand
- Korea, Republic of
- Chile
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Switzerland; Malaysia; Australia; China; Argentina and 8 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.