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:

General requirements (apply to all conditions):

• Adults between 18 and 70 years old (male or female)
• Blood, liver, clotting, and heart test results that fall within the ranges required by the trial (confirm specific values with trial site)
• People who are able and willing to use reliable contraception or abstain from sex during treatment and for at least 6 months after treatment ends; women who could become pregnant must have a negative pregnancy blood test within 7 days before joining and must not be breastfeeding
• People who are willing to voluntarily participate, sign a consent form, follow the study requirements, and attend follow-up appointments

Systemic Lupus Erythematosus (SLE) — additional requirements:

• A previous diagnosis of SLE confirmed using recognised international classification criteria
• A disease activity score (modified SLEDAI-2K) of 8 or higher at the screening visit
• Evidence of active disease affecting at least one organ system at a high level, or at least two organ systems at a moderate level, based on a standard scoring tool called BILAG-2004
• Certain antibody blood test results consistent with SLE (such as ANA, anti-dsDNA, or anti-Smith antibodies above defined levels)

Systemic Sclerosis (SSc) — additional requirements:

• A diagnosis of systemic sclerosis confirmed using 2013 international classification criteria
• If lung involvement is present, specific findings on a chest scan (HRCT) and reduced lung function below 70% of expected values on breathing tests
• Disease that has not responded to standard treatment, or has relapsed after a period of improvement; standard treatment is defined as corticosteroids (at high doses) and cyclophosphamide, plus at least 6 months of one or more other immune-modifying medications from a defined list
• Evidence of worsening skin or lung disease based on specified measurement thresholds

Primary Sjögren's Syndrome (pSS) — additional requirements:

• A diagnosis of primary Sjögren's syndrome confirmed using 2002 or 2016 international classification criteria
• A disease activity score (ESSDAI) of 5 or higher as assessed by the treating doctor
• Disease that has not responded to standard treatment, or has relapsed after a period of improvement (same definition of standard treatment as described above for SSc)

Rheumatoid Arthritis (RA) — additional requirements:

• A diagnosis of moderately or severely active rheumatoid arthritis confirmed using 2010 international criteria, with the diagnosis made at least 6 months before joining
• At least 6 swollen joints and at least 6 tender joints at the screening visit (assessed using standard joint counts)
• Elevated inflammation markers in blood tests (CRP or ESR) at the screening visit
• Disease classified as refractory rheumatoid arthritis under international guidelines, meaning previous treatments including multiple types of disease-modifying medications have not worked adequately, the disease is still considered a significant problem by both the patient and the doctor, and there is evidence of ongoing active or progressive disease

ANCA-Associated Vasculitis — additional requirements:

• A diagnosis of ANCA-associated vasculitis (including microscopic polyangiitis, granulomatous polyangiitis, or eosinophilic granulomatous polyangiitis) confirmed using 2022 international criteria
• Positive blood test results for ANCA-related antibodies (MPO-ANCA or PR3-ANCA)
• A vasculitis activity score (BVAS) of 15 or higher out of 63
• Kidney function (eGFR) of at least 15 mL/min/1.73 m² at the screening visit

Who may not be able to join:

General exclusions (apply to all conditions):

• People with a known serious allergy or intolerance to any of the medications used in the trial (cyclophosphamide, fludarabine, or tozumab)
• People with an active infection that is uncontrolled or not currently being treated (bacterial, viral, fungal, or other)
• People with nervous system conditions — whether caused by their autoimmune disease or not — such as epilepsy, psychiatric conditions, stroke, encephalitis, or central nervous system vasculitis
• People with significant heart conditions such as angina, heart attack, heart failure, or serious irregular heartbeat
• People with a condition where the immune system cannot produce immunoglobulins (a type of antibody) from birth
• People with a current or past cancer diagnosis, with exceptions for certain non-spreading skin cancers or cancers of the cervix, bladder, or breast that have been in remission for more than 5 years
• People with end-stage kidney failure
• People with active hepatitis B, hepatitis C, HIV, or syphilis, based on blood test results (specific test thresholds apply — confirm with trial site)
• People with a serious mental illness or significant cognitive impairment
• People who have participated in another clinical trial within the past 6 months
• Women who are pregnant or planning to become pregnant
• People with high blood pressure or diabetes that cannot be adequately controlled with medication
• People excluded for other reasons at the investigator's discretion

SLE-specific exclusions:

• People with a significant medical history involving the heart, hormones, blood, liver, immune system, metabolism, urinary system, lungs, nerves, skin, kidneys, or mental health (other than SLE), if this could interfere with the study treatment
• People with an active skin condition separate from SLE that could affect how SLE is assessed during the study, such as psoriasis, dermatomyositis, systemic sclerosis, or certain other skin conditions

Primary Sjögren's Syndrome-specific exclusions:

• People whose Sjögren's-like condition was caused by environmental, dietary, or injection-related factors, or who have another autoimmune disease alongside Sjögren's syndrome (such as lupus, rheumatoid arthritis, or polymyositis)

Sjögren's Syndrome-specific exclusions (confirm with trial site, as source labelling is inconsistent):

• People with liver cirrhosis
• People with aplastic anaemia, myelodysplastic syndrome, or other bone marrow conditions

Rheumatoid Arthritis-specific exclusions:

• People whose rheumatoid arthritis has resulted in the most severe level of physical disability (ACR functional status grade 4)

ANCA-Associated Vasculitis-specific exclusions:

• People with a kidney function (eGFR) below 15 mL/min/1.73 m²
• People with lung bleeding (alveolar haemorrhage) who require invasive breathing support expected to continue beyond the screening period

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