History of chronic inflammatory or autoimmune disease (eg, Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, rheumatoid arthritis, hypophysitis, uveitis, etc) with symptomatic disease within the last years; Note: active vitiligo or alopecia or a history of vitiligo or alopecia will not be a basis for exclusion
Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring active systemic treatment; hypothyroidism without evidence of Graves disease or Hashimotos thyroiditis is permitted
Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) or who are receiving systemic therapy for an autoimmune disease; exceptions include vitiligo, hypothyroidism controlled on hormone replacement, type I diabetes, Graves disease,\r\nadrenal insufficiency on stable replacement doses of steroids (prednisone =< mg/day or equivalent), or with principal investigator approval
Subjects with a history of autoimmune disease (active or past), such as but not restricted to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; autoimmune-related thyroid disease, type I diabetes and vitiligo are permitted if the condition is well controlled
Autoimmune disease or history of primary immunodeficiency (excluding Hashimotos thyroiditis, vitiligo, or DM type I)
History of chronic autoimmune disease (e.g. systemic lupus erythematosus or Wegeners granulomatosis, Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, hypophysitis, etc.) with symptomatic disease within the years before enrollment; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion; in addition, a past history of certain autoimmunity e.g. rheumatoid arthritis or thyroiditis may be allowed per principal investigator (PI) discretion provided it has been quiescent for a minimum of three years; the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last years may be included\r\n* Patients with celiac disease controlled by diet alone\r\n* Active or history of inflammatory bowel disease (colitis, Crohns), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea
History of chronic autoimmune disease (e.g., Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
History of autoimmune disease, such as, but not restricted to: rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years; patients with vitiligo or diabetes are not excluded; replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; patients with recent history of thyroiditis; subjects with remote history (greater than years) of thyroiditis are not excluded
History of chronic autoimmune disease (e.g., Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
No prior or currently active autoimmune disease requiring management with systemic immunosuppression; this includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogrens syndrome, sarcoidosis, or other rheumatologic disease including Addisons disease, Graves disease, Hashimotos thyroiditis, hypophysitis, uveitis); asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; active vitiligo or alopecia, or a history of vitiligo or alopecia is acceptable
Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis
Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves disease, or Hashimotos thyroiditis
History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (example [e.x.]: fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
DOSE ESCALATION COHORT: Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who are receiving systemic therapy for an autoimmune or inflammatory disease\r\n* Exceptions include subjects with vitiligo, hypothyroidism stable on hormone replacement, controlled asthma, type I diabetes, Graves' disease, Hashimoto's disease, or with PI approval
DOSE EXPANSION COHORT: Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who are receiving systemic therapy for an autoimmune or inflammatory disease; exceptions include subjects with vitiligo, hypothyroidism stable on hormone replacement, controlled asthma, type I diabetes, Graves' disease, Hashimoto's disease, or with PI approval
Active autoimmune process (eg rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who have been receiving therapy for an autoimmune or inflammatory disease; vitiligo, thyroiditis, or eczema is permitted if patient is otherwise eligible
History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addisons disease, multiple sclerosis, Graves' disease, Hashimotos thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.g. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
Active or history of chronic autoimmune disease (e.g., systemic lupus erythematosus or Wegeners granulomatosis, Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, rheumatoid arthritis, hypophysitis, polymyositis, sarcoidosis, etc.) with symptomatic disease within the years before randomization; Note: subjects with vitiligo, Graves' disease or psoriasis not requiring systemic treatment within the past years will not be excluded
History of, or active autoimmune disease (such as autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjgrens syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, Crohn's or Graves' disease); patients with type diabetes mellitus or vitiligo are not excluded if the condition is well controlled
History of chronic autoimmune disease (e.g., Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; prior history of autoimmune thyroiditis or vitiligo is permitted
Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; patients receiving replacement thyroid hormone would be eligible
Autoimmune diseases such as the following: autoimmune neutropenia, thrombocytopenia, hemolytic anemia, systemic lupus erythematosus, Sjogrens syndrome, scleroderma, myasthenia gravis, Goodpastures syndrome, Addisons disease, Hashimotos thyroiditis, or active Graves disease
Known history of autoimmune conditions including, but not limited to: rheumatoid arthritis, multiple sclerosis, lupus erythematosus, scleroderma, sarcoidosis, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis;
History of chronic autoimmune disease (e.g., systemic lupus erythematosus or Wegeners granulomatosis, Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, hypophysitis, etc.) with symptomatic disease within the years before randomization; note: active vitiligo or a history of vitiligo will not be a basis for exclusion; in addition, a past history of certain autoimmunity eg rheumatoid arthritis or thyroiditis may be allowed per Principal Investigator (PI) discretion provided it has been quiescent for a minimum of three years
The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease. Patients with vitiligo are not excluded.
The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease.
History of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus, localized lupus, Sjogrens syndrome, scleroderma, myasthenia gravis, Goodpastures syndrome, Addisons disease, Hashimotos thyroiditis, or Graves disease); persons with vitiligo are not excluded
History of or active autoimmune disease including but not limited to autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogrens syndrome, scleroderma, myasthenia gravis, Goodpastures syndrome; persons with vitiligo are not excluded; Persons with well-controlled autoimmune endocrinopathies, e.g., diabetes mellitus, Graves disease, Hashimotos thyroiditis, Addisons disease are not excluded; persons with well-controlled rheumatoid arthritis, psoriatic arthritis and polymyalgia rheumatica are not excluded
History of auto?immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, multiple sclerosis, Hashimotos thyroiditis, or Graves disease