Dosing and treatment of immune-mediated diseases and biomarkers associated with immune-mediated diseases

A method of treating an immune mediated disease or atopic dermatitis in an adolescent subject in need thereof, comprising administering to the adolescent subject an anti-OX40 ligand (OX40L) antibody or antigen binding fragment thereof, wherein the antibody or antigen binding fragment thereof comprises a heavy chain complementarity determining region (HCDR) 1 of SEQ ID NO:

• 42, an HCDR2 of SEQ ID NO:
• 44, and an HCDR3 of SEQ ID NO:
• 46, and a light chain complementarity determining region (LCDR) 1 of SEQ ID NO:
• 56, an LCDR2 of SEQ ID NO:
• 58, and an LCDR3 of SEQ ID NO:
• 60.

A method of treating an immune mediated disease or atopic dermatitis in a subject in need thereof, comprising administering to the subject an anti-OX40 ligand (OX40L) antibody or antigen binding fragment thereof, wherein the antibody or antigen binding fragment thereof comprises a heavy chain complementarity determining region (HCDR) 1 of SEQ ID NO:

• 42, an HCDR2 of SEQ ID NO:
• 44, and an HCDR3 of SEQ ID NO:
• 46, and a light chain complementarity determining region (LCDR) 1 of SEQ ID NO:
• 56, an LCDR2 of SEQ ID NO:
• 58, and an LCDR3 of SEQ ID NO:
• 60, wherein the subject has a body weight ranging from about 25 kg to about 40 kg.

A method of treating atopic dermatitis in a subject in need thereof, comprising:

• administering to the subject an anti-OX40 ligand (OX40L) antibody or antigen binding fragment thereof, wherein the antibody or antigen binding fragment thereof comprises a heavy chain complementarity determining region (HCDR) 1 of SEQ ID NO:
• 42, an HCDR2 of SEQ ID NO:
• 44, and an HCDR3 of SEQ ID NO:
• 46, and a light chain complementarity determining region (LCDR) 1 of SEQ ID NO:
• 56, an LCDR2 of SEQ ID NO:
• 58, and an LCDR3 of SEQ ID NO:
• 60, wherein efficacy is maintained at week 28 off of treatment or at week 32 after final administration of the antibody or antigen binding fragment thereof to the subject;
• administering to the subject amlitelimab, wherein the subject receives directly doses every 12 weeks (Q12W), without prior dose administration every 4 weeks (Q4W), and wherein the subject receives an initial dose of about 500 mg of amlitelimab followed by one or more secondary doses of about 250 mg of amlitelimab;
• administering to the subject amlitelimab, wherein the adolescent subject receives an initial dose of about 250 mg of amlitelimab followed by one or more secondary doses of about 125 mg of amlitelimab, and wherein the subject receives doses Q12W from the start of treatment, wherein the subject is an adolescent;
• administering to the subject amlitelimab, wherein the subject has a body weight ranging from about 25 kg to about 40 kg, wherein the subject receives an initial dose of about 250 mg of amlitelimab followed by one or more secondary doses of about 125 mg of amlitelimab, and wherein the subject receives doses Q12W from the start of treatment;
• administering to the subject amlitelimab, wherein the subject receives directly doses every 12 weeks (Q12W), without prior dose administration every 4 weeks (Q4W), wherein the subject receives an initial dose of about 500 mg of amlitelimab followed by one or more secondary doses of about 250 mg of amlitelimab, and wherein the method results in a decrease of the level of at least one biomarker in the subject relative to a control;
• administering to the subject amlitelimab, wherein the subject receives directly doses every 12 weeks (Q12W), without prior dose administration every 4 weeks (Q4W), and wherein the subject receives an initial dose of about 500 mg of amlitelimab followed by one or more secondary doses of about 250 mg amlitelimab;
• administering to the subject amlitelimab, wherein the subject receives directly doses every 12 weeks (Q12W), without prior dose administration every 4 weeks (Q4W), and wherein the subject receives an initial dose of about 500 mg of amlitelimab followed by one or more secondary doses of about 250 mg of amlitelimab;
• or
• administering to the subject amlitelimab, wherein the subject receives directly doses every 12 weeks (Q12W), without prior dose administration every 4 weeks (Q4W), and wherein the subject receives an initial dose of about 500 mg of amlitelimab followed by one or more secondary doses of about 250 mg of amlitelimab, and wherein efficacy is maintained at week 28 off of treatment or at week 32 after final administration of amlitelimab.