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Phase 2 Study of Nemolizumab for Skin Thickening in Adults with Systemic Sclerosis

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What is this trial about?

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

Systemic sclerosis is a rare condition that causes the skin to become thick and hard and can affect internal organs such as the lungs and heart. The study is testing an investigational drug called nemolizumab, which is given as a small injection under the skin, compared with a matching placebo. The medication is being examined to see if it can improve the skin changes and be safe for long‑term use.

The purpose of the study is to determine whether the drug can reduce skin thickness and be tolerated well over an extended period.

Participants will receive either the study medication or placebo by injection regularly for about one year and may continue for up to three years if they choose to stay in the extension phase. During the study, doctors will check the skin using a tool called the modified Rodnan Skin Score, which rates how tight the skin feels, and will perform a breathing test known as forced vital capacity to monitor lung function. Routine check‑ups will also include simple safety measurements such as blood tests, vital signs, and questions about any side effects.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit (week 0)

    The first appointment after joining the study includes collection of medical history, physical examination, and baseline measurements such as skin thickness using the modified roddan skin score and lung function testing.

    Blood samples are taken to assess laboratory values and to store for future analysis.

  2. Step 2

    Randomization and first injection

    Participants are assigned in a double‑blind manner to receive either nemolizumab 30 mg solution for injection or a matching placebo.

    The study medication is administered by subcutaneous injection using a pre‑filled pen.

    The injection schedule and exact frequency are defined by the study protocol but are not detailed in the provided information.

  3. Step 3

    Main treatment period (52‑week)

    Participants receive regular subcutaneous injections of the assigned study medication for a total of 52 weeks.

    Clinic visits are scheduled periodically to monitor safety, record any adverse events, and perform efficacy assessments such as the modified roddan skin score and forced vital capacity measurement.

    Blood samples are collected to measure nemolizumab serum concentrations and to detect anti‑drug antibodies.

  4. Step 4

    Primary efficacy assessment at week 52

    At the end of the 52‑week period, the change from baseline in the modified roddan skin score is evaluated as the primary outcome.

    Secondary outcomes include changes in lung function, response according to the revised composite response index in systemic sclerosis, and safety evaluations.

  5. Step 5

    Continuation into extension period

    Participants who remain in the study continue receiving the same study medication for an additional 156 weeks.

    The decision to continue is made according to the study protocol and participant consent.

  6. Step 6

    Extension treatment period (weeks 53‑208)

    Ongoing subcutaneous injections are administered throughout the 156‑week extension.

    Regular safety monitoring continues, including assessment of vital signs, laboratory tests, weight, and electrocardiogram findings.

    Additional blood samples are taken to continue monitoring nemolizumab levels and anti‑drug antibodies.

  7. Step 7

    Final study visit (week 208)

    The study concludes after 208 weeks (52 weeks + 156 weeks).

    Final evaluations of skin thickness, lung function, safety data, and laboratory parameters are performed.

    The study medication is discontinued and participants are provided with information about post‑study follow‑up.

Who can join the trial?

20 criteria

  • Be at least 18 years old (or meet the legal adult age in your country if it is higher).
  • Have a diagnosis of systemic sclerosis that meets the 2013 ACR/EULAR classification criteria (the standard guidelines doctors use to confirm this condition).
  • For diffuse cutaneous systemic sclerosis (DcSSc), have a Modified Rodnan Skin Score (mRSS) of 12 to 29 at both the screening visit and the start of the study; for limited cutaneous systemic sclerosis (LcSSc), have an mRSS of 8 or higher at both visits. (The mRSS is a simple test doctors use to measure how thick the skin is.)
  • Not have a positive anti‑centromere blood test if you have LcSSc (this test looks for a specific antibody that is not allowed in this group).
  • Have a disease duration that is:
    • 5 years or less if you have DcSSc, or
    • 2 years or less if you have LcSSc.
    • Be taking any background medicines for at least 3 months before the study and keep them stable, which may include:
      • Nintedanib (150 mg or less twice a day), and/or
      • One of the following, but not both together:
        • Methotrexate (25 mg or less once a week), or
        • Mycophenolate (up to 3000 mg daily for MMF, up to 2160 mg daily for MPS or MPA).
        • If your disease started 18 months ago or less, you automatically meet the activity requirement. If it started more than 18 months ago, you must have at least two of the following seven signs:
          • Two new areas of skin involvement in the past 6 months.
          • An increase of 3 or more points in the mRSS in the past 6 months.
          • One new area of skin involvement plus an increase of 2 or more points in the mRSS in the past 6 months.
          • Evidence of tendon friction rub, arthritis, or tenosynovitis that cannot be explained by another cause.
          • A high‑sensitivity CRP level of 0.6 mg/dL or higher (a blood test that shows inflammation) or an ESR of 28 mm/hr or higher (another inflammation test).
          • Evidence of lung involvement called SSc‑ILD seen on a special chest scan (HRCT) or a positive anti‑topoisomerase I (anti‑Scl‑70) antibody test (≥20 U/mL).
          • An mDAI score of 2.5 or higher (a score that measures overall disease activity).
          • Use effective contraception or agree to abstain from sex if you could become pregnant (or have a partner who could become pregnant) during the study and for at least 12 weeks after the last dose. Emergency contraception (such as Plan B™) is not allowed as a regular method.
          • If you are a woman who cannot become pregnant, you must meet one of the following:
            • No menstrual periods for at least 1 year for reasons not related to health problems; if you are under 60, a blood test showing a follicle‑stimulating hormone (FSH) level of 40 IU/L or higher confirms menopause (no test needed if you are over 60).
            • Have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before screening.
            • Sign the informed consent form and be willing and able to follow all study procedures, including using an electronic device for questionnaires.

Who cannot join the trial?

20 criteria

  • If a blood test shows you are positive for the anti‑centromere antibody (a specific protein marker) and you have limited‑type systemic sclerosis, you cannot join the study.
  • If a blood test shows you are positive for the anti‑RNA polymerase III antibody and your disease has lasted more than 18 months, you are excluded.
  • If your kidney function test called creatinine clearance is less than 30 ml/min, you cannot participate.
  • If you have a current infection with hepatitis B, hepatitis C, or HIV (shown by positive blood tests), you are not eligible.
  • If you have an active bacterial, viral, fungal, or any serious infection that required a hospital stay or IV antibiotics/antivirals within the past 4 weeks, or oral antibiotics within the past 2 weeks, you are excluded.
  • If you have a known primary immune system problem, have had a bone‑marrow transplant, or have received advanced cell therapies such as CAR‑T cell therapy, you cannot join.
  • If you have had any cancer or blood‑forming disease in the last 5 years, you are excluded, except for treated skin cancers (basal cell carcinoma, squamous cell carcinoma in situ, cervical carcinoma in situ) or treated actinic keratoses with no recurrence in the past 12 weeks.
  • If you have a history of alcohol or drug dependence, or any condition that might make it difficult for you to follow study rules, you are not eligible.
  • If you have any other medical problem—including significant lung disease, mental health condition, or abnormal lab results—that could put you at risk or affect the study’s results, you are excluded.
  • If you are taking, or are expected to take, any of the following medicines and cannot stop them: systemic steroids, anti‑malarial drugs, cyclosporine, tacrolimus, other calcineurin inhibitors, cyclophosphamide, chlorambucil, biologic agents, anti‑CD‑20 therapies, cell‑depleting therapies, total lymphoid radiation, thalidomide, intravenous immunoglobulin, antifibrotic agents, soluble guanylate‑cyclase modulators, JAK inhibitors, tyrosine‑kinase inhibitors, penicillamine, or any other investigational drug, you cannot participate.
  • You must not drink alcohol or use other substances while you are in the study.
  • If your lung function is very low—specifically, forced vital capacity (FVC) less than 50 % of the normal predicted value or diffusing capacity (DLCO) less than 40 % of normal—you are excluded. This also includes severe chronic obstructive pulmonary disease, severe asthma, recent serious lung infections, frequent lung infections, current smoking, other serious respiratory diseases, or being listed for a lung transplant within the next year.
  • If you have serious heart problems such as a dangerous irregular heartbeat needing treatment, advanced heart failure (New York Heart Association Class III‑IV), unstable chest pain (angina), uncontrolled high blood pressure, cor pulmonale (right‑heart failure due to lung disease), fluid around the heart (pericardial effusion), a heart attack in the past 6 months, or severe pulmonary hypertension (WHO Class III or higher), you cannot join.
  • If you have severe malabsorption requiring intravenous nutrition, a recent episode of scleroderma‑related kidney crisis (SRC) within 6 months, or chronic liver disease (any Child‑Pugh stage), you are excluded.
  • If you weigh less than 30 kg (about 66 lb) at screening, you cannot participate.
  • If you are pregnant, breastfeeding, planning to become pregnant, or not willing to use reliable birth control during the study, you are excluded.
  • If you have already been treated with the study drug nemolizumab, you cannot join.
  • If you have another primary rheumatic autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjögren’s syndrome, anti‑synthetase syndrome, or mixed connective‑tissue disease, you are excluded.
  • If you have a condition that looks like systemic sclerosis but is actually something else—such as localized scleroderma (morphea), eosinophilic fasciitis, graft‑versus‑host disease with skin thickening, certain fibromucinous skin disorders, or skin disease caused by chemicals or drugs—you cannot participate.
  • If you have had a severe allergic reaction (including anaphylaxis) to any immunoglobulin product or to any ingredient in the study medication, you are excluded.
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Investigated drugs

Nemluvio is an injectable medicine that is given under the skin. In this study it is being tested to see if it can help reduce the thickening of the skin that occurs in adults with systemic sclerosis. The drug works by targeting a specific part of the immune system that is thought to contribute to the skin changes in this disease. Participants receive the medication over a 52‑week main treatment period, and the study continues to follow safety and long‑term effects for up to 156 weeks. The goal is to find out how well Nemluvio works and how safe it is for people with this condition.

What is already known about the treatment

Nemolizumab - Nemolizumab is given as a powder that is mixed with a liquid and injected under the skin using a pre‑filled pen. It is an investigational drug that is currently being studied in clinical trials for skin and connective‑tissue diseases such as systemic sclerosis. The drug is designed to treat the thickening of skin that occurs in this condition by blocking a protein called interleukin‑31 receptor A, which reduces inflammation and nerve signaling that contribute to skin changes. It belongs to the class of monoclonal antibodies that target cytokine receptors.

Investigated diseases

Systemic sclerosis - Systemic sclerosis is a long‑lasting condition that causes the skin to become tight and thick. It often starts with swelling of the fingers or hands and may spread to the arms, face, and other parts of the body. Over time, the skin changes can be accompanied by hardening of blood vessels and small organs. The disease can also affect internal organs such as the lungs, heart, and kidneys, usually developing gradually. Symptoms may increase in intensity before stabilizing, and the condition can vary from mild to more extensive involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522294-11-00Protocol codeSPR207796Estimated enrolment154 patientsSponsorGalderma S.A.

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