Phase 1 Lupus 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:

• You have been diagnosed with Systemic Lupus Erythematosus (SLE, a chronic immune system disease), confirmed by recognized medical guidelines, and certain specific antibodies were found in your blood tests.
• Your SLE is currently active, affecting at least one major organ, and has not responded well enough to steroids and at least 2 other treatments (such as certain immune-suppressing medications) used for at least 3 months each.
• You have been diagnosed with Idiopathic Inflammatory Myopathy (IIM, a group of muscle inflammation diseases) — specifically dermatomyositis, immune-mediated necrotizing myopathy, anti-synthetase syndrome, or polymyositis — confirmed by recognized medical guidelines.
• You have IIM with moderate or severe muscle and/or skin involvement that is currently active, shown by a rash, a recent muscle biopsy, very elevated muscle enzymes in your blood, or progressive scarring lung disease.
• Your IIM has not responded well enough to steroids and at least 2 other treatments used for at least 3 months each.
• You have been diagnosed with Systemic Sclerosis (SSc, also called scleroderma), confirmed by recognized medical guidelines, and have a positive ANA blood test.
• You have a specific type of SSc (diffuse cutaneous, or either type with progressive scarring lung disease) that has not responded well enough to at least 1 approved treatment used for at least 3 months.
• You have Rheumatoid Arthritis (RA) with at least 3 swollen and 3 tender joints, OR RA with progressive scarring lung disease, that has not responded well enough to at least one standard medication and at least 2 other types of more advanced RA medications used for at least 3 months each.

Who may not be able to join:

• Your lupus was caused by a medication rather than occurring on its own.
• You have another systemic autoimmune disease (such as multiple sclerosis, psoriasis, or inflammatory bowel disease) — though some conditions like type 1 diabetes, thyroid autoimmune disease, celiac disease, or secondary Sjögren's syndrome may not exclude you (confirm with trial site).
• You have SLE that overlaps with other conditions such as rheumatoid arthritis, scleroderma, or mixed connective tissue disease.
• You have had a significant brain or nervous system condition within the last 12 months.
• Your muscle disease is a type not covered by this trial, such as Inclusion Body Myositis, Amyopathic Dermatomyositis, any juvenile form of myositis, drug-induced myositis, or myositis related to HIV.
• You have severe permanent muscle damage, permanent weakness from a non-muscle-disease cause (such as a stroke), or myositis that has affected your heart.
• You have SSc-related high blood pressure in the lungs (pulmonary arterial hypertension) that currently requires active treatment.
• You have rapidly progressing SSc-related severe intestinal problems requiring feeding through a vein, or a specific stomach blood vessel condition.
• You have had a kidney crisis related to scleroderma in the past.
• You have a history of, or currently have, an inflammatory joint disease other than rheumatoid arthritis.
• You have joint damage or deformity that could make it hard for the doctor to accurately assess your RA disease activity.
• There are additional criteria not listed here that may also apply (confirm with trial site).

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