Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OpSCF · 1 trial · 1 indication
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation\[I\], excoriation\[Ex\] \& lichenification\[L\]) was scored separately for each of 4 body regions\[head(h), upper extremities(u), trunk(t), lower extremities(l)\] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(\< 10%),2 (10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1\*(Eh+Ih+Exh+Lh)\*Ah + 0.2\*(Eu+Iu+Exu+Lu)\*Au + 0.3\*(Et +It+Ext+Lt)\*At + 0.4\*(El+Il+Exl+Ll)\*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.
| Arm | Type | Description |
|---|---|---|
| OpSCF 600 mg | EXPERIMENTAL | Participants received OpSCF 600 milligrams (mg), once every 2 weeks (Q2W), subcutaneously (SC), up to 14 weeks in the placebo-controlled period. |
| OpSCF Matching-Placebo | PLACEBO_COMPARATOR | Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period. |
| OpSCF 600 mg/OpSCF 600mg | EXPERIMENTAL | Participants who received OpSCF 600 mg and completed placebo-controlled treatment received OpSCF 600mg, once every 4 weeks (Q4W), SC, up to 36 weeks in the open-label extension (OLE) period. |
| OpSCF Matching-Placebo/OpSCF 600 mg | PLACEBO_COMPARATOR | Participants who received OpSCF matching-placebo and completed placebo-controlled treatment received OpSCF 600mg, Q4W, SC, up to 36 weeks in the OLE period. |
| Name | Type | Description |
|---|---|---|
| OpSCF | BIOLOGICAL | Administered SC. |
| Placebo | BIOLOGICAL | Administered SC. |
Inclusion Criteria: * Subject has clinically confirmed diagnosis of active AD. * Subject has at least a 6-month history of AD * Subject is willing to use effective birth control Exclusion Criteria: * Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during ...
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