Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with systemic sclerosis (a condition also called scleroderma) according to recognised 2013 medical classification standards.
• People with the diffuse form of systemic sclerosis (where skin thickening spreads more widely across the body) who have a skin severity score within a specific range (not too mild, not too severe) at both their initial assessment and their baseline visit.
• People with the limited form of systemic sclerosis (where skin thickening is more localised) who have a skin severity score at or above a certain level at both assessments, and who test negative for a specific antibody called anti-centromere.
• People with the diffuse form whose condition was first detected (beyond a specific early symptom called Raynaud's phenomenon) within the last 5 years, or people with the limited form within the last 2 years.
• People who have signs that their disease is currently active or getting worse.
• People who are already taking certain background medications at stable doses for at least 3 months — specifically, nintedanib (below a certain dose), methotrexate (below a certain dose), or a mycophenolate-based medicine (below certain doses). These may be taken alone or in certain combinations (confirm with trial site for exact combinations allowed).
• Women who cannot become pregnant (confirm with trial site for the specific definition used).
• Men whose female partners could become pregnant, and women who could become pregnant, who are willing to use effective contraception or commit to abstinence during the study and for at least 12 weeks after the last treatment.
• People who have read and signed the informed consent form.

Who may not be able to join:

• People with the limited form of systemic sclerosis who test positive for the anti-centromere antibody.
• People who test positive for the anti-RNA polymerase 3 antibody and whose disease has been present for more than 18 months.
• People whose kidneys are not filtering blood well enough (below a certain threshold measured by a standard formula — confirm with trial site).
• People who test positive for hepatitis B, hepatitis C (with a confirmatory positive test), or HIV.
• People whose lung function tests show that both lung capacity and gas transfer are below certain minimum levels at screening and baseline.
• People with significant breathing conditions other than lung scarring related to their systemic sclerosis — such as severe chronic obstructive pulmonary disease, severe asthma, a recent serious respiratory infection (within 3 months), a history of repeated respiratory infections, or current smoking.
• People who are already on a waiting list for a lung transplant, or who are expected to be listed within the next 12 months.
• People with serious heart conditions, including significant irregular heartbeat requiring treatment, heart failure of a certain severity (Class III–IV), unstable chest pain, uncontrolled high blood pressure, right-sided heart failure related to lung disease, or troublesome fluid around the heart.
• People who have had a heart attack within the 6 months before screening.
• People with pulmonary hypertension (high blood pressure in the lungs) that is severe enough to require treatment and falls into a specific functional category (Class III or higher).
• People with severe problems absorbing nutrients from food, or who need to be fed through a vein (parenteral nutrition).
• People who have had a serious kidney crisis related to their scleroderma within the 6 months before screening.
• People with chronic liver disease of any severity level.
• People who weigh less than 30 kilograms at screening or at the baseline visit.
• Women who are pregnant, breastfeeding, planning to become pregnant or breastfeed, or who are unwilling to use appropriate contraception during the study.
• People who have previously been treated with the study drug, nemolizumab.
• People whose primary diagnosis is another autoimmune rheumatic disease (such as rheumatoid arthritis, lupus, or related conditions) rather than systemic sclerosis.
• People with a scleroderma-like condition that is not true systemic sclerosis, such as localised scleroderma, certain other connective tissue conditions, or conditions caused by chemical or drug exposure.
• People with a known history of severe allergic reactions (including anaphylaxis) to antibody-based medicines or to ingredients in the study treatment.
• People with a known active infection (bacterial, viral, fungal, or other) that has required hospitalisation or treatment with intravenous antibiotics or antivirals within the past 4 weeks, or oral antibiotics within the past 2 weeks. Rescreening may be possible once the infection has cleared (confirm with trial site).
• People with a history of a primary immune deficiency condition.
• People who have had a bone marrow transplant, CAR-T cell therapy, or any other treatment involving genetically engineered cells.
• People with a history of blood or lymph system cancers, or any other cancer within the past 5 years — with limited exceptions for certain treated skin cancers with no signs of return (confirm with trial site for exact exceptions).
• People with a history of alcohol or substance dependence, or any condition that, in the treating doctor's opinion, would make it difficult for the person to follow study instructions reliably.
• People with any medical, psychological, or laboratory condition that the treating doctor believes could put the person at undue risk, prevent them from completing the study, or affect the reliability of study results.
• People who have not followed the required restrictions on certain treatments before screening, or who are not expected to follow those restrictions during the study.

Important: Always verify eligibility with the trial site directly before applying.