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 |