DOSING REGIMENS FOR SELECTIVE TREG STIMULATOR RUR20kD-IL-2 AND RELATED COMPOSITIONS

A method of treating a human subject having an autoimmune disease comprising administering to the human subject in an induction phase a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose, of rezpegaldesleukin;

• wherein said administering is carried out once weekly, once every 2 weeks, once every 3 weeks, once every 4 weeks, once every 6 weeks, or once every 8 weeks;
• wherein said rezpegaldesleukin is administered for a total of 12 weeks, a total of 16 weeks, a total of 20 weeks, or a total of 24 weeks of administration in said induction phase;
• followed by a maintenance phase comprising administering to the human subject a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose, of rezpegaldesleukin;
• wherein said administering is carried out once every 2 weeks, once every 4 weeks, once every 6 weeks, once every 8 weeks, once every 12 weeks, once every 24 weeks, once every 36 weeks, once every 48 weeks, or once every 52 weeks;
• wherein said rezpegaldesleukin is administered for a total of 4 weeks to 52 weeks of administration, or a total of 1 to 5 years of administration;
• wherein said autoimmune disease is selected from:
• systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's disease, rheumatoid arthritis, atopic dermatitis, systemic sclerosis, ankylosing spondylitis, graft versus host disease, and polymyositis;
• type 1 diabetes, Addison's disease, Hashimoto thyroiditis, Graves' disease, Sjogren's syndrome, vitiligo, pernicious anemia, glomerulonephritis, lupus nephritis, myasthenia gravis, Goodpasture's syndrome, autoimmune hemolytic anemia, idiopathic thrombocytopenia purpura, peanut allergy, pulmonary fibrosis, celiac disease, alopecia areata, psoriasis, Hidradenitis suppurativa or asthma.

A method of treating moderate to severe atopic dermatitis in a patient in need thereof, comprising administering to the human subject in an induction phase a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose, of rezpegaldesleukin;

• wherein said administering is carried out once weekly, once every 2 weeks, once every 3 weeks, once every 4 weeks, once every 6 weeks, or once every 8 weeks;
• wherein said rezpegaldesleukin is administered for a total of 12 weeks, a total of 16 weeks, a total of 20 weeks, or a total of 24 weeks of administration in said induction phase;
• determining if the patient is a responder to the rezpegaldesleukin after the induction period;
• and if the patient is a responder, proceed to a maintenance phase comprising administering to the human subject a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose, of rezpegaldesleukin;
• wherein said administering is carried out once every 2 weeks, once every 4 weeks, once every 6 weeks, once every 8 weeks, once every 12 weeks, once every 24 weeks, once every 36 weeks, once every 48 weeks, or once every 52 weeks;
• wherein said rezpegaldesleukin is administered for a total of 4 weeks to 52 weeks of administration, or a total of 1 to 5 years of administration.

A method of reducing sleep loss in a patient with moderate to severe atopic dermatitis in a patient in need thereof, comprising administering to the human subject in an induction phase a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose, of rezpegaldesleukin;

• wherein said administering is carried out once weekly, once every 2 weeks, once every 3 weeks, once every 4 weeks, once every 6 weeks, or once every 8 weeks;
• wherein said rezpegaldesleukin is administered for a total of 12 weeks, a total of 16 weeks, a total of 20 weeks, or a total of 24 weeks of administration in said induction phase;
• determining if the patient is a responder to the rezpegaldesleukin after the induction period;
• and if the patient is a responder, proceed to a maintenance phase comprising administering to the human subject a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose, of rezpegaldesleukin;
• wherein said administering is carried out once every 2 weeks, once every 4 weeks, once every 6 weeks, once every 8 weeks, once every 12 weeks, once every 24 weeks, once every 36 weeks, once every 48 weeks, or once every 52 weeks;
• wherein said rezpegaldesleukin is administered for a total of 4 weeks to 52 weeks of administration, or a total of 1 to 5 years of administration.

A selective Treg stimulator RUR20kD-IL-2 and related composition comprising a composition of Formulae A-F for use in the treatment of an autoimmune disease in a patient, wherein the patient is administered in an induction phase a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose;

• wherein said administering is carried out once weekly, once every 2 weeks, once every 3 weeks, once every 4 weeks, once every 6 weeks, or once every 8 weeks;
• wherein said composition is administered for a total of 12 weeks, a total of 16 weeks, a total of 20 weeks, or a total of 24 weeks of administration in said induction phase;
• followed by a maintenance phase comprising administering to the human subject a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose;
• wherein said administering is carried out once every 2 weeks, once every 4 weeks, once every 6 weeks, once every 8 weeks, once every 12 weeks, once every 24 weeks, once every 36 weeks, once every 48 weeks, or once every 52 weeks;
• wherein said rezpegaldesleukin is administered for a total of 4 weeks to 52 weeks of administration, or a total of 1 to 5 years of administration;
• wherein said autoimmune disease is selected from:
• systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's disease, rheumatoid arthritis, atopic dermatitis, systemic sclerosis, ankylosing spondylitis, graft versus host disease, and polymyositis;
• type 1 diabetes, Addison's disease, Hashimoto thyroiditis, Graves' disease, Sjogren's syndrome, vitiligo, pernicious anemia, glomerulonephritis, lupus nephritis, myasthenia gravis, Goodpasture's syndrome, autoimmune hemolytic anemia, idiopathic thrombocytopenia purpura, peanut allergy, pulmonary fibrosis, celiac disease, alopecia areata, psoriasis, Hidradenitis suppurativa or asthma.

A selective Treg stimulator RUR20kD-IL-2 and related composition comprising a composition of Formulae A-F for use in the treatment of severe atopic dermatitis in a patient in need thereof, comprising administering to the human subject in an induction phase a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose;

• wherein said administering is carried out once weekly, once every 2 weeks, once every 3 weeks, once every 4 weeks, once every 6 weeks, or once every 8 weeks;
• wherein said composition is administered for a total of 12 weeks, a total of 16 weeks, a total of 20 weeks, or a total of 24 weeks of administration in said induction phase;
• determining if the patient is a responder to the composition after the induction period;
• and if the patient is a responder, proceed to a maintenance phase comprising administering to the human subject a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose;
• wherein said administering is carried out once every 2 weeks, once every 4 weeks, once every 6 weeks, once every 8 weeks, once every 12 weeks, once every 24 weeks, once every 36 weeks, once every 48 weeks, or once every 52 weeks;
• wherein said composition is administered for a total of 4 weeks to 52 weeks of administration, or a total of 1 to 5 years of administration.

A selective Treg stimulator RUR20kD-IL-2 and related composition comprising a composition of Formulae A-F for use in reducing sleep loss in a patient with moderate to severe atopic dermatitis in a patient in need thereof, comprising administering to the human subject in an induction phase a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose, of rezpegaldesleukin;

• wherein said administering is carried out once weekly, once every 2 weeks, once every 3 weeks, once every 4 weeks, once every 6 weeks, or once every 8 weeks;
• wherein said rezpegaldesleukin is administered for a total of 12 weeks, a total of 16 weeks, a total of 20 weeks, or a total of 24 weeks of administration in said induction phase;
• determining if the patient is a responder to the rezpegaldesleukin after the induction period;
• and if the patient is a responder, proceed to a maintenance phase comprising administering to the human subject a dose of about 300 μg, about 450 μg, about 600 μg, about 900 μg, about 1200 μg, about 1500 μg, about 1800 μg, about 2100 μg, about 2400 μg, about 2700 μg, about 3000 μg, about 3300 μg, or about 3600 μg per dose, of rezpegaldesleukin;
• wherein said administering is carried out once every 2 weeks, once every 4 weeks, once every 6 weeks, once every 8 weeks, once every 12 weeks, once every 24 weeks, once every 36 weeks, once every 48 weeks, or once every 52 weeks;
• wherein said rezpegaldesleukin is administered for a total of 4 weeks to 52 weeks of administration, or a total of 1 to 5 years of administration.