Early Phase 1 Vasculitis Trial, Recruiting

Written by an AI model from the 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 aged 18 to 65 years (inclusive) at the time of signing consent, of any gender, who are willing and able to follow the study procedures.
• People who have been diagnosed with systemic lupus erythematosus (SLE) according to established 2019 classification standards, with a high level of disease activity measured by standard scoring tools, and whose disease has not responded well to standard treatments for more than 6 months, or whose disease has flared after a period of remission.
• People who have been diagnosed with an inflammatory muscle disease (idiopathic inflammatory myopathy, or IIM — including dermatomyositis, polymyositis, anti-synthetase syndrome, or necrotizing myopathy) according to 2017 classification standards, with a positive blood test for specific muscle disease antibodies, with moderate-to-severe disease activity, and whose disease has not responded to standard treatments, has relapsed, or is getting worse over time.
• People who have been diagnosed with systemic sclerosis (scleroderma) according to 2013 classification standards, with a positive blood test for specific antibodies related to this condition, and whose disease has not responded to standard treatments or is progressively worsening (including significant worsening of skin tightening or lung function decline).
• People who have been diagnosed with ANCA-associated vasculitis (a type of blood vessel inflammation) according to 2022 classification standards, with a positive blood test for specific antibodies (MPO-ANCA or PR3-ANCA), with a high disease activity score, and whose disease has not responded to standard treatments or has relapsed after remission.
• People who have been diagnosed with Sjögren's syndrome according to 2002 or 2016 classification standards, with a disease activity score of 6 or higher, a positive blood test for anti-SSA/Ro antibody, and whose disease has not responded to standard treatments or has relapsed after remission.
• People whose blood test results at screening meet specific safety thresholds, including adequate white blood cell counts, haemoglobin, platelet levels, liver enzyme levels, kidney function, clotting measurements, heart function (with a heart pumping efficiency of 50% or above, and no significant heart rhythm concerns on ECG), and blood oxygen level above 92% while breathing normal room air.
• Female participants of childbearing potential who have a negative pregnancy blood test at the screening stage.
• Male participants with female partners, and female participants who are able to become pregnant, who agree to use effective contraception from the time of screening until at least one year after the last dose of the study treatment.

Who may not be able to join:

• People with SLE caused by a medication, those experiencing a lupus crisis, or those who in the treating doctor's assessment are not suitable candidates.
• People with inflammatory muscle disease (IIM) who have inclusion body myositis, drug-caused or cancer-associated muscle inflammation, or a non-inflammatory muscle condition such as muscular dystrophy.
• People with IIM who have uncontrolled lung disease with severely reduced lung function (FVC below 55%) or who require oxygen therapy, severe swallowing difficulties that could increase risk, or severe heart complications such as heart failure, dangerous irregular heartbeat, or recent heart attack.
• People with systemic sclerosis who have severe uncontrolled high blood pressure in the lungs related to their condition, rapidly worsening gut involvement requiring intravenous nutrition, active stomach blood vessel lesions, or severely uncontrolled lung disease with oxygen levels below 92% on room air, or who have needed breathing machine support within the past year.
• People with ANCA-associated vasculitis who have certain types of severe kidney inflammation, acute nerve involvement, or brain/nervous system involvement unrelated to vasculitis at screening, life-threatening vasculitis complications (such as serious lung bleeding, bowel perforation, or heart or brain vessel involvement), or vasculitis caused by another condition such as lupus, a drug, cancer, or infection.
• People with Sjögren's syndrome who have poorly controlled severe disease that the treating doctor believes poses excessive risk, Sjögren's syndrome that is secondary to another confirmed autoimmune disease (such as rheumatoid arthritis or lupus), a need for regular use of medications known to commonly cause dry mouth or dry eyes, or other conditions that could interfere with assessing Sjögren's treatment results (such as inflammatory bowel disease, gout, sarcoidosis, or similar conditions).
• People with a history of severe allergic reactions or anaphylaxis.
• People who have a known allergy or contraindication to any ingredient in the study treatment.
• People with significant heart conditions, including moderate-to-severe heart failure (NYHA Class III or IV), a heart attack or major heart surgery within the past 6 months, significant irregular heart rhythms, unexplained fainting episodes not caused by dehydration or a simple reflex response, a prolonged QT interval on ECG (above 480 ms), or a history of severe non-ischaemic heart muscle disease.
• People with an active cancer, or a history of cancer diagnosed within the past 5 years — with certain exceptions for very early-stage or non-spreading skin cancers, cervical carcinoma in situ, or breast carcinoma in situ that have been treated with curative intent.
• People with another known autoimmune disease beyond the condition they are being enrolled for.
• People who need long-term use of blood-thinning medications that affect clotting.
• People who have had significant bleeding (such as gastrointestinal bleeding) within the past 6 months, have a hereditary or acquired bleeding or clotting disorder, or have had a blood clot event (such as stroke, deep vein thrombosis, or pulmonary embolism) within the past 6 months.
• People with serious underlying health conditions at screening, including uncontrolled or active infections currently being treated with intravenous antibiotics, significant cognitive impairment or altered mental state, or a history of neurological conditions such as epilepsy, stroke, severe brain injury, Parkinson's disease, or psychosis.
• People who test positive at screening for HIV, active hepatitis B, active hepatitis C, or active syphilis.
• People with detectable active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) in their blood.
• People with active tuberculosis or untreated latent (inactive) tuberculosis prior to screening.
• People who have taken another experimental drug within 4 weeks before signing consent, or within fewer than 5 half-lives of that drug (whichever period is longer).
• People who have had plasma exchange or immunoadsorption therapy within 4 weeks before starting the study drug.
• People who have received B-cell targeting therapies (such as belimumab or telitacicept) within 6 months before starting the study drug.
• People who have received certain biologic therapies such as anti-TNF-alpha antibody treatments within 12 weeks before starting the study drug.
• People who have received certain immune-suppressing medications (such as tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, methotrexate, or similar drugs) within 2 weeks before starting the study drug.
• People who have received FcRn antagonist therapy (such as efgartigimod) within 3 weeks before starting the study drug.
• People who have received complement inhibition therapy (such as eculizumab) within 3 weeks before starting the study drug.
• People who have received a live attenuated or mRNA vaccine within 8 weeks before enrolment, or an inactivated vaccine within 2 weeks before enrolment.
• People who have had major surgery within 8 weeks before screening, or who are planning to have surgery during the study period.
• People who have previously had an organ, bone marrow, or blood stem cell transplant.
• People who have previously received any CAR-T cell therapy.
• People who, in the treating doctor's judgement, have any condition that could prevent them from completing the study, interfere with the results, or make participation not in their best interest.

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