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Systemic scleroderma – Trials in Disease

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Ongoing Clinical Trials for Systemic Scleroderma

There are currently 20 clinical trials studying treatments for systemic scleroderma (also known as scleroderma, systemic sclerosis). These studies are taking place across multiple countries in Europe and are testing various approaches including cell therapies, biological medications, and novel drug compounds. The trials focus on improving skin thickness, lung function, and overall quality of life for patients with this challenging autoimmune condition.

Clinical trial locations

Study comparing rapcabtagene autoleucel and rituximab in patients with severe refractory diffuse cutaneous systemic sclerosis

This trial is testing a new cell therapy called rapcabtagene autoleucel in people with severe diffuse cutaneous disease. The condition must have affected areas near the elbows or knees, and participants need to be between 18 and 65 years old. Disease symptoms should have started within the last 7 years, not counting Raynaud’s phenomenon.

Who can join: Participants must have severe, progressive disease showing lung involvement, worsening skin hardening, or heart problems. The study accepts both men and women who meet these health requirements.

Who cannot join: People who have previously received rituximab treatment are not eligible. Those with active infections like hepatitis or HIV, serious heart problems, severe kidney or liver disease, or active cancer cannot participate. Pregnant or breastfeeding women are also excluded, as are people who had major surgery within 8 weeks before the study.

The treatment approach: The study compares rapcabtagene autoleucel with rituximab. Rapcabtagene autoleucel involves modifying a patient’s own immune cells in a laboratory to target cells causing the disease. Rituximab is an antibody medication that reduces certain immune cells. Both are given through intravenous infusion.

Before receiving the main treatment, participants undergo preparation with cyclophosphamide and fludarabine phosphate. The study lasts 52 weeks, with doctors monitoring lung function, skin thickness, and ability to perform daily activities.

Study of Hydroxychloroquine Safety and Effectiveness in Patients with Early Systemic Sclerosis

This Italian study examines whether hydroxychloroquine can help people with early-stage disease when added to their standard treatments. Participants must be 18 years or older and have had symptoms for 5 years or less.

Who can join: People diagnosed according to specific medical criteria who score 20 or higher on the Mouth Handicap Scale are eligible. They must have a Rodnan skin score of 1 or higher on the face and limited mouth opening of less than 40 millimeters. Participants need to be on stable treatment for at least 4 weeks before joining.

Who cannot join: Those who are pregnant, breastfeeding, or have serious heart, kidney, or liver problems cannot participate. People with eye problems affecting the retina, uncontrolled diabetes, active infections, or seizure history are excluded. Recent participation in other trials or inability to follow study procedures also disqualify potential participants.

The treatment approach: Participants receive either hydroxychloroquine tablets or placebo daily for 52 weeks. The dose is calculated based on body weight, up to 400 mg daily. Doctors monitor skin changes, blood vessel function, pain, morning stiffness, and fatigue throughout the year.

Study of Sodium Thiosulfate Injections for Patients with Ectopic Calcifications or Ossifications from Dermatomyositis, Systemic Sclerosis, or iPPSD2

This French trial studies sodium thiosulfate injections for abnormal calcium deposits or bone formations in people with dermatomyositis, systemic sclerosis, or a rare genetic condition called iPPSD2.

Who can join: Adults 18 years or older with calcium deposits caused by dermatomyositis or systemic sclerosis are eligible. Young people aged 2 to 30 with abnormal bone formation from iPPSD2 can also participate. A medical expert panel must confirm the need for this treatment based on the significant health impact. Participants should have no planned surgery for these deposits in the next 12 months.

Who cannot join: People with deposits or bone formations from other causes are excluded. Those outside the specified age ranges or unable to provide informed consent cannot join. Pregnant or breastfeeding women, people with recent surgeries, and those unable to follow study procedures are not eligible.

The treatment approach: Sodium thiosulfate is given as injections under the skin directly into affected areas. The study evaluates whether this treatment can reduce the size of abnormal deposits over six months. Participants receive treatment once or twice with a three-month interval between doses.

Study on the Effectiveness and Safety of Efgartigimod PH20 SC for Adults with Systemic Sclerosis

This multi-country trial tests efgartigimod PH20 SC in adults with skin hardening. The study runs across Poland, Bulgaria, Croatia, France, Germany, Romania, Belgium, Spain, Netherlands, Portugal, Italy, Lithuania, Denmark, Czechia, Greece, and Hungary.

Who can join: Participants must be at least 18 years old and meet classification criteria for either diffuse or limited disease. They need a positive antinuclear antibodies test with a titer of at least 1:160. A Health Assessment Questionnaire score of at least 0.5 or Patient Global Assessment score of at least 3 is required. The skin score must be between 15 and 35. Timing of first symptoms varies based on antibody status: less than 5 years for those without anti-RNA polymerase III antibodies, or less than 2 years for those with these antibodies.

Who cannot join: People with other serious health conditions, those who are pregnant or breastfeeding, and recent participants in other trials are excluded. Those with severe allergic reactions to study medications, active infections requiring treatment, or major surgery within 3 months cannot join.

The treatment approach: Efgartigimod PH20 SC combines efgartigimod and rHuPH20, given as subcutaneous injections. The study lasts 48 weeks and monitors skin thickness changes and overall health throughout the treatment period.

Study on the Effectiveness and Safety of Ianalumab for Patients with Diffuse Cutaneous Systemic Sclerosis

This trial operates in Greece, Hungary, Germany, Austria, France, Spain, Portugal, Belgium, Italy, and Poland, testing ianalumab for diffuse cutaneous disease.

Who can join: Men and women aged 18 to 70 years with a diagnosis meeting specific criteria are eligible. Disease duration must be 60 months or less since first symptoms. The skin score must be between 15 and 45 at screening. The disease must be active, meeting at least one criterion such as disease duration of 18 months or less, recent increases in skin score, new body area involvement, elevated inflammation markers, presence of interstitial lung disease with specific antibodies, or a disease activity score greater than 2.5. Participants must test positive for at least one autoantibody.

Who cannot join: People without diffuse cutaneous disease or those outside the age range cannot participate.

The treatment approach: Ianalumab is administered through subcutaneous injection over 52 weeks. This monoclonal antibody targets specific immune cells to reduce inflammation. Antiviral medications may be given orally as supportive therapy. The study monitors safety and effectiveness throughout the treatment period.

Study on the Effectiveness of Nintedanib and Tocilizumab for Patients with Systemic Sclerosis and Interstitial Lung Disease

This Polish study examines the combination of nintedanib and tocilizumab for people with both skin hardening and lung scarring.

Who can join: Men and women aged 18-74 with documented diagnosis according to specific criteria are eligible. Participants must have interstitial lung disease confirmed by lung scan showing at least 10% involvement. The skin score must be between 10 and 45. Those taking mycophenolate mofetil or methotrexate must have stable doses for at least 8 weeks. Oral corticosteroids must be stable at no more than 10 mg/day of prednisone equivalent for 8 weeks.

Who cannot join: People with different types of lung disease not related to the condition, recent infections requiring antibiotics, severe allergic reactions to study medications, current participation in another trial, or cancer history within 5 years are excluded. Those with uncontrolled high blood pressure, heart disease, liver or kidney disease, or who are pregnant or breastfeeding cannot join.

The treatment approach: Nintedanib soft capsules and tocilizumab injections are compared to standard treatments with methotrexate and mycophenolate mofetil. The 56-week study monitors lung function, skin thickness, and ability to perform daily activities.

Study on the Effects of Belimumab in Adults with Systemic Sclerosis-Associated Interstitial Lung Disease

This trial across Germany, Italy, Denmark, Spain, Greece, Belgium, France, and Finland tests belimumab injections for lung disease associated with the condition.

Who can join: Participants must be 18 years or older with documented diagnosis and diffuse cutaneous disease showing thickened skin over areas near elbows or knees. They must have interstitial lung disease and show signs of active or worsening disease. Suitable skin areas for subcutaneous injection in the abdomen or thigh are required. Participants or caregivers must be able and willing to give themselves the medication. Women must not be pregnant or breastfeeding and should use effective birth control if of childbearing age.

Who cannot join: Those with other serious health conditions, recent infections, conflicting medications, history of allergic reactions to similar treatments, pregnancy or breastfeeding, recent participation in other trials, substance abuse history, or mental health conditions affecting study compliance are excluded.

The treatment approach: Belimumab is given as subcutaneous injections in pre-filled syringes containing 200 mg of solution. Treatment continues for 52 weeks alongside standard therapies. The study monitors lung function decline and overall safety.

Study on the Safety of Allogeneic Adipose-Derived Mesenchymal Stromal Cells for Patients with Severe Systemic Sclerosis

This French trial examines the safety of allogeneic adipose-derived mesenchymal stromal cells for severe cases.

Who can join: Adults over 18 years with diagnosis according to specific guidelines are eligible. Participants must have severe disease with conditions such as disease duration of 2 years or less with a skin score of 20 or more, or a skin score of 15 or more with major organ involvement like respiratory issues, kidney problems, or heart issues. There must be a reason not to undergo a specific treatment called AHSCT. Women of childbearing age and men capable of fathering children must use effective birth control.

Who cannot join: People with other serious health conditions, those who are pregnant or breastfeeding, recent trial participants, those with severe allergic reactions, inability to follow procedures, active infections, cancer history within 5 years, drug or alcohol abuse history, or history of organ transplant are excluded.

The treatment approach: The therapy involves intravenous infusion of cells obtained from fat tissue and grown in a laboratory. Treatment is given once or twice with a three-month interval, with monitoring for safety and effectiveness over 12 months.

Study on the Safety of CNTY-101 and Aldesleukin for Patients with Active Autoimmune Diseases: Lupus, Scleroderma, and Myositis

This German study tests CNTY-101 cell therapy combined with aldesleukin for people with active B-cell driven autoimmune diseases including idiopathic inflammatory myositis, systemic lupus erythematosus, and systemic sclerosis.

Who can join: Participants must have one of three conditions: idiopathic inflammatory myositis, systemic lupus erythematosus meeting 2019 criteria, or systemic sclerosis. Those with myositis must show active muscle inflammation on biopsy or imaging, or signs of lung disease, and test positive for specific antibodies. If experiencing muscle weakness, specific test scores are required. Those with myopathy and lung disease need specific lung function measurements and antibody positivity.

Who cannot join: People with other autoimmune diseases, serious infections in the past month, current immunosuppressive treatment, cancer history within 5 years, recent live vaccines, uncontrolled high blood pressure, pregnancy or breastfeeding, substance abuse within the past year, recent trial participation, or known allergies to study medication are excluded.

The treatment approach: CNTY-101 is a cell therapy using NK cells derived from stem cells, given through intravenous infusion. Aldesleukin is administered as subcutaneous injections. The treatment aims to reduce harmful B cells that attack the body’s tissues.

Study on the Safety of MB-CART19.1 for Patients with Active Systemic Lupus Erythematosus, Systemic Sclerosis, or Dermatomyositis/Polymyositis

This German trial tests MB-CART19.1, a CAR T-cell therapy, for people with active systemic lupus erythematosus, systemic sclerosis, or dermatomyositis/polymyositis.

Who can join: Adults 18 years or older meeting classification criteria for systemic sclerosis, dermatomyositis, polymyositis, or systemic lupus erythematosus are eligible. For systemic sclerosis, participants must test positive for at least one specific marker, show signs of fast disease progression, and have not responded to or cannot tolerate at least two specific treatments. Similar requirements exist for dermatomyositis/polymyositis and systemic lupus erythematosus. Adequate kidney, liver, heart, and lung function is required. Participants must use effective contraception.

Who cannot join: People with dermatomyositis/polymyositis, systemic sclerosis, or systemic lupus erythematosus as exclusion criteria are listed, which appears to be an error in the source data.

The treatment approach: Anti-CD19 CAR T-cell therapy uses specially modified cells from the patient’s own immune system, changed in a laboratory to better recognize and attack disease-causing cells. Treatment is given through intravenous infusion, with monitoring for side effects and effectiveness.

Summary

The 20 ongoing clinical trials for systemic scleroderma demonstrate significant research activity across Europe, with France and Germany hosting the most studies. These trials explore diverse treatment approaches including innovative cell therapies, biological medications targeting specific immune system components, and novel drug compounds.

Several trials focus on early-stage disease, recognizing the importance of intervention before irreversible organ damage occurs. Many studies specifically address lung involvement, reflecting this as a major concern in systemic scleroderma. The trials generally require participants to have tried and failed standard treatments, indicating these studies target patients with difficult-to-treat disease.

Cell-based therapies represent an emerging area, with multiple trials testing mesenchymal stem cells and modified immune cells. Biological medications targeting B-cells and various inflammatory pathways are also prominent. The studies typically run for 48-52 weeks, allowing time to assess meaningful changes in skin thickness, lung function, and quality of life.

Most trials exclude pregnant or breastfeeding women, people with active infections, recent cancer, or severe organ dysfunction. The age ranges generally span from 18 to 75 years, with specific requirements varying by study. Many trials require participants to maintain stable background therapy throughout the study period.

Ongoing Clinical Trials on Systemic scleroderma

  • Study on the Effectiveness and Safety of Ianalumab for Patients with Diffuse Cutaneous Systemic Sclerosis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Greece Hungary +4

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

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Denmark France Germany Italy +5

  • Study on the Effects of Belimumab in Adults with Systemic Sclerosis-Associated Interstitial Lung Disease

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Finland France Germany Greece +2

  • Study on Treating Calcinosis Cutis in Systemic Sclerosis Patients with Sodium Thiosulfate, Cetrimide, and Lidocaine

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Lebrikizumab in Adults with Moderate to Severe Localized Scleroderma

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Using 68Ga-FAPI-46 imaging to detect fibrosis in patients with inflammatory diseases such as Crohn’s disease, ulcerative colitis, systemic sclerosis, and lung fibrosis.

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • A Study Testing Anti-CD19 CAR T-Cell Therapy in Patients with Systemic Sclerosis Who Did Not Respond to Immunosuppressive Drugs

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of adipose-derived mesenchymal stem cell injections to treat mouth fibrosis in patients with systemic scleroderma

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

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