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 ...
Top 20 of 26 competitors
OpSCF is an investigational monoclonal antibody being developed for atopic dermatitis, also known as eczema. It is specifically being studied in adults with moderate to severe forms of the condition. Insmed Incorporated is evaluating the drug in a Phase 2 clinical program.
OpSCF is being developed by Insmed Incorporated, a biopharmaceutical company that trades on the Nasdaq under the ticker symbol INSM. Insmed is the sponsor of the clinical program evaluating the drug in atopic dermatitis.
OpSCF is in Phase 2 clinical development. A Phase 2a study in moderate to severe atopic dermatitis has been completed. The drug is investigational and has not been approved by the FDA for any indication.
OpSCF has been studied in one clinical trial, NCT06101823, a Phase 2a study of efficacy and safety in moderate to severe atopic dermatitis. The trial enrolled 50 adults, was randomized, double-blind, and placebo-controlled, and was conducted in the United States and Canada. It is now completed.
Yes. OpSCF is a monoclonal antibody. It is being developed as an investigational therapy for atopic dermatitis, a chronic inflammatory skin condition, and was evaluated in a Phase 2a randomized, double-blind, placebo-controlled trial in adults with moderate to severe disease.