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Study of Amlitelimab and BI 1015550 for Patients with Interstitial Lung Disease Due to Scleroderma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as interstitial lung disease secondary to systemic sclerosis (SSc-ILD). This is a lung disease that occurs in people with a condition called scleroderma, which affects the skin and other organs. The study will explore the effects of two investigational treatments, Amlitelimab and BI 1015550, as well as their matching placebos. Amlitelimab is administered as a solution for injection using a pre-filled syringe, while BI 1015550 is taken orally in the form of a film-coated tablet.

The purpose of the study is to evaluate the safety and effectiveness of these investigational treatments in people with SSc-ILD. Participants will be randomly assigned to receive either the investigational treatment or a placebo. The study will last for a period of 52 weeks, during which participants will receive regular doses of the assigned treatment. Throughout the study, participants will undergo various assessments to monitor their lung function and overall health.

The main goal is to observe any changes in lung function, specifically measuring the forced vital capacity (FVC), which is the amount of air a person can exhale after taking a deep breath. This will help determine if the investigational treatments can improve lung function in people with SSc-ILD. The study will also look at other health indicators to provide a comprehensive understanding of the treatments' effects. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be randomly assigned to receive either the investigational product or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  2. Step 2

    Treatment administration

    Participants will receive one of the investigational products: amlitelimab or BI 1015550, or their matching placebos.

    Amlitelimab is administered as a solution for injection using a pre-filled syringe.

    BI 1015550 is provided in the form of a film-coated tablet for oral consumption.

  3. Step 3

    Treatment duration

    The treatment period lasts for 52 weeks. During this time, participants will continue to receive their assigned treatment according to the study protocol.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants will undergo regular assessments to monitor their health and the effects of the treatment.

    The primary focus is on measuring changes in forced vital capacity (FVC), which is a measure of lung function, from the start of the study to the end of the treatment period at Week 52.

  5. Step 5

    Secondary assessments

    Additional assessments include changes in lung imaging results, dyspnea (difficulty breathing) scores, and skin scores for those with diffuse cutaneous systemic sclerosis.

    These assessments help evaluate the overall impact of the treatment on the participant's condition.

  6. Step 6

    Completion of the study

    At the end of the 52-week treatment period, participants will complete their final assessments.

    The data collected will be used to evaluate the safety and effectiveness of the investigational products compared to the placebo.

Who can join the trial?

8 criteria

  • Must be a male or female who is at least 18 years old at the time of giving consent to participate.
  • Must have a classification of **systemic sclerosis (SSc)** according to the 2013 criteria set by the American College of Rheumatology and the European League Against Rheumatism. There is a limit on the number of participants with a specific type of SSc called limited/sine cutaneous SSc.
  • The first symptom of **systemic sclerosis** (not including Raynaud's phenomenon) must have started 5 years or less before the screening visit.
  • For participants with **diffuse cutaneous systemic sclerosis**, the **Modified Rodnan Skin Score (mRSS)**, which measures skin thickness, must be between 10 and 35.
  • Must have **interstitial lung disease (ILD)** with signs of any lung scarring on a special lung scan called **high-resolution computed tomography (HRCT)**, done within 3 months before being randomly assigned to a treatment group.
  • Must have a **forced vital capacity (FVC)**, which is a measure of lung function, that is at least 45% of what is considered normal.
  • Must have a **diffusing capacity of the lung for carbon monoxide (DLCO)**, which measures how well the lungs transfer gas, that is at least 30% of what is considered normal, adjusted for hemoglobin levels.
  • Other specific criteria defined by the study protocol may also apply.

Who cannot join the trial?

7 criteria

  • Patients with other types of lung diseases not related to **systemic sclerosis**. **Systemic sclerosis** is a condition that affects the skin and internal organs.
  • Patients who have had a recent lung infection or other serious illness that could affect the study results.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate.
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Investigated drugs

  • Nintedanib

    is a medication used in this trial to help manage interstitial lung disease associated with systemic sclerosis. It works by slowing down the scarring process in the lungs, which can help improve breathing and lung function over time.

  • Rituximab

    is another medication being tested in the trial. It is an antibody therapy that targets specific cells in the immune system. By doing so, it may help reduce inflammation and slow down the progression of lung disease in patients with systemic sclerosis.

  • Abatacept

    is included in the trial as well. This medication works by interfering with the activity of certain immune cells that contribute to inflammation and tissue damage. It aims to help control the symptoms of interstitial lung disease in systemic sclerosis patients.

  • Tofacitinib

    is also part of the study. It is a medication that inhibits certain enzymes involved in the inflammatory process. By reducing inflammation, it may help improve lung function and overall health in patients with systemic sclerosis-related lung disease.

What is already known about the treatment

Nintedanib – Nintedanib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating interstitial lung disease secondary to systemic sclerosis. The medication is primarily indicated for slowing the decline in lung function in patients with this condition. At the molecular level, Nintedanib works by inhibiting multiple tyrosine kinases, which are enzymes involved in the pathways that lead to fibrosis and inflammation. It is classified as a tyrosine kinase inhibitor in pharmacology.

Investigated diseases

Interstitial Lung Disease Secondary to Systemic Sclerosis (SSc-ILD) – This disease is a type of lung condition that occurs as a complication of systemic sclerosis, a connective tissue disorder. It involves the scarring and thickening of lung tissues, which can lead to breathing difficulties. Over time, the lung's ability to transfer oxygen into the bloodstream may decrease, causing shortness of breath and reduced exercise capacity. The progression of the disease can vary, with some individuals experiencing a slow decline in lung function, while others may have a more rapid progression. Symptoms often include a persistent dry cough and fatigue. The condition is considered rare and can significantly impact quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507129-40-00Protocol codeSRF201Estimated enrolment301 patientsSponsorScleroderma Research Foundation

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