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Monoclonal Antibodies
Amlitelimab + BI 1015550 for Scleroderma (CONQUEST Trial)
Phase 2
Recruiting
Research Sponsored by Scleroderma Research Foundation, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Modified Rodnan skin score (mRSS) of 10 to 35, inclusive, in participants with diffuse cutaneous SSc
SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria
Must not have
History of myocardial infarction or unstable angina within 6 months of the Screening Visit, or plans to undergo a coronary procedure during participation in the study
Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis [TB], sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to the end of the treatment period at week 52
Summary
This trial aims to test how well different investigational products work compared to a placebo in improving lung capacity in people with Interstitial Lung Disease caused by Systemic Sclerosis.
Who is the study for?
This trial is for individuals with Interstitial Lung Disease due to Systemic Sclerosis, a type of scleroderma affecting the lungs. Participants should have measurable lung disease at the start and be able to perform certain lung function tests.
What is being tested?
The study is testing two potential treatments: Amlitelimab and BI 1015550, against a placebo. The main goal is to see if these treatments can improve lung capacity after one year compared to no treatment (placebo).
What are the potential side effects?
Potential side effects are not specified here but typically could include reactions at the injection site, flu-like symptoms, gastrointestinal issues, or changes in blood pressure or liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin thickness score is between 10 and 35.
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My condition meets the 2013 criteria for systemic sclerosis.
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I have lung scarring seen on a recent detailed lung scan.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had a heart attack or unstable chest pain in the last 6 months, nor do I plan to have heart surgery during the study.
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My lung scans show abnormalities not related to scleroderma.
Select...
I have had moderate to severe liver disease.
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I have had a stem cell, bone marrow, CAR T-cell therapy, or organ transplant.
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I have severe heart failure (NYHA Class III or IV).
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I am not pregnant, nursing, nor planning to become pregnant during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to the end of the treatment period at week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to the end of the treatment period at week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
The change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea score.
The percent change in high-resolution computed tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL);
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1015550Experimental Treatment1 Intervention
Group II: AmlitelimabExperimental Treatment1 Intervention
Group III: BI 1015550 matching placeboPlacebo Group1 Intervention
Group IV: Amlitelimab matching placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1015550
2023
Completed Phase 2
~600
Find a Location
Who is running the clinical trial?
SanofiIndustry Sponsor
2,215 Previous Clinical Trials
4,046,732 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,552 Previous Clinical Trials
15,896,711 Total Patients Enrolled
1 Trials studying Scleroderma
50 Patients Enrolled for Scleroderma
Scleroderma Research Foundation, Inc.Lead Sponsor
Kelly OliverStudy ChairScleroderma Research Foundation