Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe AD (Atopic Dermatitis)

Insmed

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: OpSCF; Biological: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06101823

OpSCF-201

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate to severe Atopic Dermatitis (Eczema). OpSCF will be compared to a placebo. OpSCF or placebo will be administered every 2 weeks for 14 weeks, and the efficacy will be assessed two weeks later. After that, subjects may choose to enter an Open Label Extension phase in which all subjects will receive OpSCF every 4 weeks for 40 additional weeks.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 the study.
• Subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results.
• Subject has used dupilumab within 26 weeks prior to Day 1.
• Subject has used tralokinumab within 12 weeks prior to Day 1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 4 patient groups, including a placebo group

OpSCF 600 mg

Experimental group

Description:

Participants received OpSCF 600 milligrams (mg), once every 2 weeks (Q2W), subcutaneously (SC), up to 14 weeks in the placebo-controlled period.

Treatment:

Biological: OpSCF

OpSCF Matching-Placebo

Placebo Comparator group

Description:

Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.

Treatment:

Biological: Placebo

OpSCF 600 mg/OpSCF 600mg

Experimental group

Description:

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.

Treatment:

Biological: OpSCF

Biological: Placebo

OpSCF Matching-Placebo/OpSCF 600 mg

Placebo Comparator group

Description:

Participants who received OpSCF matching-placebo and completed placebo-controlled treatment received OpSCF 600mg, Q4W, SC, up to 36 weeks in the OLE period.

Treatment:

Biological: OpSCF

Biological: Placebo