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

NCT06101823 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OpSCF-201
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 22

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Eczema; Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) at 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.

  Baseline, Week 16

Secondary Outcomes (18)

• 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

• Percentage of Participants Achieving At-Least 50% Improvement From Baseline in EASI (EASI50)

  At Weeks 2, 4, 6, 8, 10, 12, 14, and 16

• Percentage of Participants Achieving At-Least 75% Improvement From Baseline in EASI (EASI75)

  At Weeks 2, 4, 6, 8, 10, 12, 14, and 16

Study Arms (4)

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.

Biological: OpSCF

OpSCF Matching-Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

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.

Biological: OpSCF; Biological: Placebo

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.

Biological: OpSCF; Biological: Placebo

Interventions

OpSCF BIOLOGICAL

Administered SC.

Also known as: Humanized IgG4k, SCF248

OpSCF 600 mg; OpSCF 600 mg/OpSCF 600mg; OpSCF Matching-Placebo/OpSCF 600 mg

Placebo BIOLOGICAL

Administered SC.

OpSCF 600 mg/OpSCF 600mg; OpSCF Matching-Placebo; OpSCF Matching-Placebo/OpSCF 600 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (22)

Cahaba Dermatology & Skin Health Center

Birmingham, Alabama, 33607, United States

Location

First OC Dermatology Research

Fountain Valley, California, 92708, United States

Location

Axon Clinical Research

Inglewood, California, 90301, United States

Location

University Clinical Trials

San Diego, California, 92123, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Skin Care Research

Boca Raton, Florida, 33456, United States

Location

Skin Research of South Florida

Miami, Florida, 33173, United States

Location

RM Medical Research

Miami Lakes, Florida, 33014, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Options Research Group

West Lafayette, Indiana, 47906, United States

Location

DS Research of Kentucky

Louisville, Kentucky, 40241, United States

Location

Oakland Hills Dermatology P.C

Auburn Hills, Michigan, 48326, United States

Location

Saginaw Bay Dermatology

Bay City, Michigan, 48706, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

Rodgers Dermatology

Frisco, Texas, 75034, United States

Location

Dermatology Of Seattle

Bellevue, Washington, 98004, United States

Location

Oshawa Clinic Dermatology Trials

Oshawa, Ontario, L1H 1B9, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N2, Canada

Location

Innovaderm Research Inc

Montreal, Quebec, H2X 2V1, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Insmed Medical Information
• Organization: Insmed Incorporated

medicalinformation@insmed.com

18444467633

Study Officials

• Study Director

  Insmed Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 26, 2023
• Study Start: November 21, 2023
• Primary Completion: September 3, 2024
• Study Completion: August 18, 2025
• Last Updated: September 11, 2026
• Results First Posted: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); CA (4)