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Clinical Study for Scleroderma with Interstitial Lung Disease

This study is testing two investigational products, Amlitelimab and BI 1015550 (Nerandomilast), against a placebo to see if they can improve lung capacity in people with Interstitial Lung Disease (ILD) due to scleroderma. Scleroderma is a disease that causes hardening of the skin and connective tissues. You may be able to join if you are 18 years or older and have scleroderma as defined by specific medical criteria. The main goal is to measure changes in your forced vital capacity (FVC), which is how much air you can exhale after a deep breath, from the start of the study to 52 weeks later. The current status of this study is unclear, and it plans to enroll 400 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 400 participants.
What's involved
Amlitelimab will be given as an injection under the skin. BI 1015550 (Nerandomilast) will be taken by mouth twice a day as tablets. The primary endpoint is measured at Week 52.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at the end of the treatment period at Week 52.

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NCT06195072

Platform Clinical Study for Conquering Scleroderma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Scleroderma Research Foundation, Inc.
~400 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:AmlitelimabBI 1015550 (Nerandomilast)Placebo

At a glance

Recruiting sites
23 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The change in forced vital capacity (FVC, in mL).
Measured over from baseline to the end of the treatment period at Week 52

Conditions

Interstitial Lung Disease Due to Systemic Disease
Scleroderma

Explore related trials

Interstitial Lung DiseaseSystemic Scleroderma

Where it's being run

34 sites across 23 states
California4
Pennsylvania4
New York3
Illinois2
Massachusetts2
Tennessee2
Alabama1
Connecticut1

Study leadership

  • Kevin O'Shea · STUDY_CHAIR · Scleroderma Research Foundation

Who to contact

Gabrielle Khedr
[email protected]
415.834.9444
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Estimated glomerular filtration rate \<45 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;
Alanine aminotransferase or aspartate aminotransferase level \> (2 x ULN);
Platelets \<100 × 109/L (100,000/μL);
White blood cell count \<2500/μL;
Neutrophil blood count \<1500/μL;
Prothrombin time and partial thromboplastin time \>1.5 × ULN, or international normalized ratio \>2; or
Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study. 11. Presence of a clinically significant disorder that, in the opinion of the Investigator, could contraindicate the administration of study product, affect compliance, interfere with study evaluations, or confound the interpretation of study results 12. Presence of a concomitant life-threatening disease with life expectancy \<12 months based on the Investigator's assessment; 13. Evidence of active tuberculosis (TB) or being at high risk for TB

What this trial measures

  • The change in forced vital capacity (FVC, in mL).from baseline to the end of the treatment period at Week 52