Early 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 have agreed to take part voluntarily and have signed a consent form
• People aged 18 to 70 years old (any sex)
• People whose liver is working within acceptable ranges on blood tests (confirm with trial site for specific values)
• People whose kidneys are working within acceptable ranges on blood tests (confirm with trial site for specific values)
• People whose blood cell counts (white cells, red cells, and platelets) are within acceptable ranges on blood tests (confirm with trial site for specific values)
• People whose blood clotting results are within acceptable ranges (confirm with trial site for specific values)
• People whose blood oxygen level is at least 92% while resting and breathing normal air
• People whose heart pumping function is at least 50%, as measured by an ultrasound of the heart
• Women who could become pregnant must have a negative pregnancy test at the start of the study
• Women who could become pregnant must agree to use a highly effective form of contraception for at least 28 days before treatment begins and for up to 12 months after receiving the study treatment
• Men who could father a child must agree to use an effective barrier contraceptive method from the start of treatment until 12 months after receiving the study treatment, and must not donate sperm during the trial

For people with Systemic Lupus Erythematosus (SLE — a disease where the immune system attacks the body's own tissues):

• People with a confirmed SLE diagnosis based on recognised international classification guidelines
• People who test positive for certain immune system markers in their blood (ANA, anti-dsDNA, or anti-Smith antibodies)
• People whose SLE disease activity score is above a certain level at the start of the study (confirm with trial site for specific values)

For people with Systemic Sclerosis (SSc — a condition involving hardening of the skin and connective tissue):

• People with a confirmed SSc diagnosis based on recognised international classification guidelines
• People with the "diffuse cutaneous" form of SSc, diagnosed within the last 6 years

For people with ANCA-Associated Vasculitis (AAV — a condition causing inflammation of blood vessels):

• People who meet recognised diagnostic criteria for AAV, including certain subtypes (Microscopic Polyangiitis, Granulomatosis with Polyangiitis, or Eosinophilic Granulomatosis with Polyangiitis)
• People who have tested positive for specific antibodies linked to this condition (MPO-ANCA or PR3-ANCA) either at the start of the study or within the 3 months before

For people with Idiopathic Inflammatory Myopathy (IIM — a group of conditions causing muscle inflammation):

• People with a confirmed IIM diagnosis based on recognised international classification guidelines, including subtypes such as Dermatomyositis, Anti-Synthetase Syndrome, or Immune-Mediated Necrotizing Myopathy
• People whose condition is currently in an active phase, shown by at least 2 out of 6 specific measures being outside normal ranges (confirm with trial site for specific measures)

For people with Sjögren's Syndrome (SS — a condition affecting moisture-producing glands):

• People with a confirmed primary Sjögren's Syndrome diagnosis based on recognised international classification guidelines
• People who have tested positive for anti-SSA/Ro antibodies either at the start of the study or within the 3 months before
• People whose Sjögren's disease activity score is 5 or above at the start of the study

Who may not be able to join:

• SLE patients who have had a severe, uncontrolled lupus crisis in the 8 weeks before the study starts, including serious complications affecting the kidneys, brain, blood, heart, lungs, liver, or blood vessels
• IIM patients who have severe muscle breakdown or very high levels of a specific muscle enzyme (CK) in their blood at the start of the study
• People with active infections that required treatment throughout the whole body (such as infectious pneumonia or tuberculosis) within 2 weeks before a certain stage of the treatment process
• People who test positive for Hepatitis B, Hepatitis C (with detectable virus in the blood), HIV, or syphilis
• Women who are pregnant or breastfeeding
• People with any other condition that, in the treating doctor's judgement, could affect their safe participation in the study or make it harder to interpret results

Note: People with severe asthma or COPD (a lung condition) may still be considered. People with mild or moderate asthma or COPD who are on stable treatment may also be considered (confirm with trial site).

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