Nemolizumab (CD14152; CIM331; humanized IgG2κ Nemolizumab (CD14152; CIM331; humanized IgG2κ Nemolizumab (CD14152; CIM331; humanized IgG2κ Nemolizumab (CD14152; CIM331; humanized IgG2κ Nemolizumab (CD14152; CIM331; humanized IgG2κ
Mechanism of biologic Anti-IL31RA monoclonal antibody blocking IL-31-dependent receptor activation and downstream signaling Anti-IL31RA monoclonal antibody blocking IL-31-dependent receptor activation and downstream signaling Anti-IL31RA monoclonal antibody blocking IL-31-dependent receptor activation and downstream signaling Anti-IL31RA monoclonal antibody blocking IL-31-dependent receptor activation and downstream signaling Anti-IL31RA monoclonal antibody blocking IL-31-dependent receptor activation and downstream signaling
Study design Randomized, placebo-controlled, double-blind, multi-center Randomized, placebo-controlled, double-blind, multi-center Randomized, placebo-controlled, double-blind, multi-center Randomized, placebo-controlled, double-blind, multi-center Randomized, placebo-controlled, double-blind, multi-center
dose ranging XCIMA study group
Identifier number JapicCTI-173740 NCT03181503 NCT03100344 NCT01986933 NA
Publication
Kabashima et al., 2020,74
Stander et al., 2020,96
Siverberg et al, 2020,80
Part A: Ruzicka et al 2017,73 Part B: Kabashima et al., 2018,71
Nemoto et al 2016,72
Phase 3 2 2B 2 1/1b
Recruitment status Completed Completed Completed Completed Completed
Duration 16 wk 16 wk 32 wk Part A:12 wk; Part B: 52 wk 127 days
Participant ethnicity Japanese NA NA NA Japanese, white
Dosing
60 mg Q4W, subcutaneous
0.5mg/kg Q4W up to wk 8, subcutaneous
10, 30, 90 mg Q4W up to wk 20, subcutaneous
Pt A: 0.1, 0.5, or 2.0 mg/kg Q4W, or 2.0 mg/kg Q8W,wk 12 Pt B: above, wk 52
0.003, 0.01, 0.03, 0.1, 0.3, 1.0, 3.0 mg/kg, single dose, subcutaneous
Sample size
N = 143 (72 PbO), (204 target size)
N = 70 (34 PbO)
N = 226 (57 PbO)
Pt A: n = 216 (264 target size); Pt B: n = 131 (191 target size) N = 145 Pt A: n = 56 (14 PbO); Pt B: n = 24 (6 PbO); Pt C: n = 36 (9 PbO)
Key inclusion/exclusion criteria AD with moderate or severe pruritus Clinical diagnosis of PN ≥ 6 months, pruritus Chronic AD ≥ 2 years Pruritic AD AD of moderate or greater severity
Primary endpoint Mean %Δ VAS (range 0-100), wk 16 %Δ pruritus NRS score using LOCF, MI and observed data, wk 4; %Δ EASI, wk 24 %Δ VAS, wk 12 Assessment of AE