Phase 1 Vasculitis 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 understand what the trial involves and are willing to sign a consent form agreeing to take part.
• People aged between 18 and 65 years old (inclusive), of any gender.
• People whose B cells (a type of immune cell) test positive for a protein called CD19, as measured by a blood test.
• People whose blood counts meet certain minimum levels — including white blood cells, red blood cells, and platelets — without having needed a blood transfusion or growth factor treatment in the 14 days before the screening test.
• People whose blood clotting results fall within an acceptable range (confirm with trial site).
• People whose heart is pumping effectively (at least 50% efficiency on an ultrasound scan), who have only mild or no shortness of breath when breathing normal air, and whose blood oxygen level is at least 92%.
• People whose liver enzyme and bilirubin levels are within acceptable limits (people with a condition called Gilbert syndrome have a slightly different threshold for bilirubin).
• People whose kidneys are filtering blood at an adequate rate, calculated using a standard medical formula.
• People diagnosed with Systemic Lupus Erythematosus (SLE, a type of lupus) who: meet recognised international diagnostic criteria for lupus; have a disease activity score above 6, indicating moderate to severe active disease; have at least one severely affected organ or two moderately affected organs as measured by a standard assessment tool; and whose disease has not responded to, or has come back after, standard treatments including steroids and other immune-suppressing or biological medicines used for more than 6 months.
• People diagnosed with Sjögren's syndrome (a condition causing dry eyes and dry mouth, among other symptoms) who: meet recognised international diagnostic criteria; have a disease activity score of 6 or higher; test positive for a specific antibody called anti-SSA/Ro; and whose disease has not responded to, or has returned after, standard treatments used for more than 6 months.
• People diagnosed with systemic sclerosis (also called scleroderma, a condition causing skin and organ hardening) who: meet recognised international diagnostic criteria with widespread (diffuse) involvement; have lung changes visible on a specialised CT scan; and either have not responded to standard treatments used for more than 6 months, or whose disease has been getting measurably worse (defined by specific changes in skin scores or lung function tests).
• People diagnosed with inflammatory myopathy (a group of conditions causing muscle inflammation, including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotising myopathy) who: meet recognised international diagnostic criteria; if muscles are affected, have a muscle strength score below a certain level and show abnormalities in at least two of five standard measures; test positive for a myositis-related antibody; and either have not responded to standard treatments used for more than 6 months, or whose lung disease linked to the condition has been worsening rapidly.
• People diagnosed with ANCA-associated vasculitis (a condition causing blood vessel inflammation) who: meet recognised international diagnostic criteria, covering three specific subtypes; test positive for specific antibodies (MPO-ANCA or PR3-ANCA); have a vasculitis activity score of 15 or more out of 63; meet certain thresholds for specific types of organ involvement on a standard assessment; and whose disease has not responded to, or has returned after, standard treatments used for more than 6 months.

Who may not be able to join:

• People who have received an RNA-LNP medicine (a type of drug delivered using tiny fat particles, such as some newer vaccines or therapies) within the past two years.
• People who have received intravenous immunoglobulin (a blood-derived immune treatment given through a drip) within the 24 weeks before screening.
• People who have had plasmapheresis (a procedure that filters the blood) within the 12 weeks before screening.
• People who have not fully recovered from surgery in the 4 weeks before screening.
• People who have epilepsy, or who are taking psychiatric or sedative medications during the screening period (sleep medications are an exception).
• People who have received a live or live-attenuated vaccine (such as certain types of flu, yellow fever, or MMR vaccines) within 12 weeks before screening, or who would need such a vaccine at any point during the trial.
• People who have taken part in another clinical drug or medical device trial within the 12 weeks before screening (unless they were screened for that trial but did not end up joining).
• People who have a history of lupus affecting the kidneys severely enough to require dialysis, or who needed very high-dose steroid treatment (more than 100 mg per day of prednisone or equivalent) within 90 days before the start of the trial.
• People who currently have active lupus affecting the central nervous system (brain and spinal cord), such as brain blood vessel inflammation, seizures, psychosis, or certain nerve conditions.
• People who have another active inflammatory or autoimmune condition — such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, or psoriatic arthritis — within 12 weeks before screening (note: people with secondary Sjögren's syndrome linked to another condition are not automatically excluded — confirm with trial site).
• People who have moderate to severe heart failure, unstable chest pain, a recent heart attack, poorly controlled high blood pressure, a recent stroke, or a heart rhythm problem requiring treatment within the 6 months before screening.
• People who have an active or uncontrolled infection, or a known or suspected long-term or recurring infection, including tuberculosis, HIV, hepatitis B, hepatitis C, or certain fungal or bacterial infections.
• People who have a known or suspected allergy to the trial drug (TI-0032-III) or similar medicines, or who have a history of severe allergic reactions.
• People who have a history of an overactive thyroid condition (such as Graves' disease or toxic goitre), or whose thyroid ultrasound shows nodules classified as category 4 or 5 on a standard risk scale.
• People who have had their spleen removed, or who have lost spleen function due to injury; or who have had major surgery within 2 months before screening; or who have planned surgery before the trial ends.
• People who have a serious mental health condition, including suicidal thoughts or behaviour in the past year, or a history of alcohol, drug, or chemical misuse within the year before screening.
• People who have had a major organ transplant (such as heart, lung, liver, or kidney) or a bone marrow or stem cell transplant.
• People who have a history of cancer of any kind, regardless of whether it is considered treated or in remission; or who have significant liver disease such as hepatitis, cirrhosis, or liver failure.
• People who test positive for HIV, or who have active hepatitis B, or who test positive for both hepatitis C antibodies and active hepatitis C virus.
• People who are pregnant, breastfeeding, or planning to become pregnant; or who test positive on a pregnancy blood test during screening; or who are unable or unwilling to use effective contraception for 12 months after the last dose of the trial drug; or who plan to donate sperm or eggs within 12 months of the last dose.
• People who have other significantly abnormal blood test or imaging results, or who the trial doctor considers unsuitable for other medical reasons.

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