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OpSCF

Phase 2

Atopic Dermatitis | Monoclonal antibody | Dermatology |Insmed Incorporated|Last Updated: Sep 11, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

OpSCF · 1 trial · 1 indication

Phase 2 1
NCT06101823Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe AD (Atopic Dermatitis)Atopic Dermatitis
COMPLETED50 Analytics
PHASE2COMPLETED
Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe AD (Atopic Dermatitis)
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Baseline, Week 16

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.

Secondary Endpoints

Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
From first dose of study drug up to end of follow-up (up to Week 67)
Percent Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, and 14
Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OpSCF 600 mgEXPERIMENTALParticipants received OpSCF 600 milligrams (mg), once every 2 weeks (Q2W), subcutaneously (SC), up to 14 weeks in the placebo-controlled period.
OpSCF Matching-PlaceboPLACEBO_COMPARATORParticipants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
OpSCF 600 mg/OpSCF 600mgEXPERIMENTALParticipants 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 mgPLACEBO_COMPARATORParticipants who received OpSCF matching-placebo and completed placebo-controlled treatment received OpSCF 600mg, Q4W, SC, up to 36 weeks in the OLE period.

Interventions

NameTypeDescription
OpSCFBIOLOGICALAdministered SC.
PlaceboBIOLOGICALAdministered SC.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites22

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 ...

Countries:United StatesCanada
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