Testing RAY121 for antiphospholipid syndrome (APS)

Exclusion

• −History of anaphylaxis or hypersensitivity to a biologic agent
• −Positive for hepatitis B surface antigen
• −Positive for hepatitis C virus antibody
• −Active infection requiring systemic antiviral, antibiotics or antifungal
• −Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study
• −Clinically significant ECG abnormalities
• −Illicit drug or alcohol abuse
• −Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjögren's syndrome in DM and IMNM)
• −Positive for human immunodeficiency virus antibody
• −Evidence of current infection with tuberculosis
• −History of cancer within 5 years
• −Treatment with investigational therapy within 28 days or 5 half-lives
• −Previous and current treatment with anti-C1s antibody at any time
• −Other complement inhibitors within 3 months
• −Patients who receive any treatments which fall into the Prohibited Therapy Criteria
• −Patients with an elevated alanine aminotransferase or aspartate aminotransferase \> 1.5 × ULN in combination with an elevated total bilirubin \> 1.5 × ULN
• −APS cohortCohortA group of participants sharing a characteristic, followed together.Read more →:
• −1\) APS associated with other systemic autoimmune disease
• −2\) Acute thrombosis (arterial or venous acute thrombosis diagnosis) within 30 days before screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −3\) Patients with thrombotic APS without any anticoagulation treatment
• −4\) Treatment with prohibited medications
• −BP cohort:
• −・ 1) Initiation of treatment with or increase in the dose of systemic or topical corticosteroid within 2 weeks
• −2\) Current treatment with a drug that may cause or exacerbate BP unless the dose has been stable
• −3\) Initiation of treatment with topical calcineurin inhibitor, or topical phosphodiesterase (PDE) 4 inhibitor within 7 days
• −4\) Treatment with prohibited medications
• −BS cohort:
• −・ 1) BS-related active major organ involvement-ocular lesions requiring immunosuppressive therapy, pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis), gastrointestinal (e.g., ulcers along the gastrointestinal tract), and central nervous systems (e.g., meningoencephalitis) manifestations
• −2\) History of venous or arterial thrombosis within 1 year
• −3\) Treatment with prohibited medications
• −DM cohort:
• −・ 1) PhGA-VAS improvement \>= 3, or clinically relevant improvement between screening and baselineBaselineYour starting measurements, taken before treatment begins.Read more →
• −2\) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → body myositis, polymyositis, IMNM, juvenile DM or drug-induced myopathy
• −3\) Cancer-associated myositis
• −4\) Significant muscle damage
• −5\) Past history of severe Interstitial lung disease flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease
• −6\) Severe respiratory muscle weakness
• −7\) Severe bulbar palsy
• −8\) Treatment with prohibited medications
• −IMNM cohort:
• −・ 1) PhGA-VAS improvement \>= 3, or clinically relevant improvement between screening and baseline
• −・ 2) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, juvenile DM or druginduced myopathy
• −・ 3) Cancer-associated myositis
• −・ 4) Significant muscle damage
• −・ 5) Past history of severe Interstitial lung disease (ILD) flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease
• −・ 6) Severe respiratory muscle weakness
• −・ 7) Severe bulbar palsy
• −・ 8) Treatment with prohibited medications
• −ITP cohort:
• −・ 1) Secondary ITP
• −・ 2) Clinical diagnosis or history of Myelodysplastic Syndrome or autoimmune hemolytic anemia
• −・ 3) History of venous or arterial thrombosis within 12 months
• −・ 4) Patients who experienced major bleeding within 4 weeks
• −5\) Treatment with prohibited medications
• −6\) Any laboratory test results meet either of the following criteria at screening:
• −Hemoglobin \<10 g/dL
• −Thyroid-stimulating hormone \>= 10 μIU/mL
• −Pregnant or breastfeeding, or intending to become pregnant
• −Planned surgery during the study