NCT07445919

A Clinical Study to Evaluate SM17 for Atopic Dermatitis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Clinical Study to Evaluate the Efficacy and Safety of SM17 Monoclonal Antibody Injection (Subcutaneous Injection) in Participants With Moderate to Severe Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: SinoMab BioScience Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is a phase 2, randomized, double-Blind, placebo-Controlled, dose-finding clinical study conducted in participants with moderate-to-severe atopic dermatitis. The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics , and pharmacodynamics of SM17 (subcutaneous injection) in participants with moderate to severe atopic dermatitis.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase 2 clinical study of participants with moderate to severe AD to evaluate the efficacy, safety, PK, PD, and immunogenicity of SM17 after multiple SC doses with different dosage regimens. This study will also explore the optimal dosage regimen to provide the basis for dose selection in subsequent clinical studies. Patients with moderate to severe AD who have an inadequate response to or are intolerant to topical corticosteroids and/or topical calcineurin inhibitors will be enrolled if eligible. The study includes a 4-week screening period, a 16-week double-blind treatment period, a 4-week open-label treatment period, and a safety follow-up period (4 weeks after the last dose). During the 16-week double-blind treatment period, 200 participants with moderate to severe AD are planned to be enrolled and randomized into 1 of 4 cohorts receiving either SM17 SC or placebo SC. Participants in each cohort will continue dosing according to the prescribed dosage regimen until Week 14 (until Week 15 for Cohort 4 \[QW dosage group\]) and will undergo a visit at the end of the double-blind treatment period at Week 16 (Day 113). From Week 16 (Day 113), enrollment to the 4-week open-label treatment period will be at the participant's discretion. Participants who opt to enter the open-label treatment period will be assigned to 1 of 2 cohorts depending on their IGA Score at Week 16. A safety follow-up will be conducted 4 weeks after the last dose (Week 24). If a participant does not enter the open-label treatment period, safety follow-up will be conducted at 4 weeks after the last dose, and the participant's participation will conclude. During the study, participants will undergo AD-related clinical efficacy assessments (including investigator assessment and patient-reported scales), safety and tolerability assessments (including laboratory tests), PK, and immunogenicity (ADA) sample collection, and sample collection related to biomarker detection within defined visit windows.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	SM17 for subcutaneous injection	SM17 monoclonal antibody for subcutaneous infusion use
DRUG	SM17 placebo for subcutaneous injection	placebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-04-25
• Completion: 2027-06-30
• First posted: 2026-03-03
• Last updated: 2026-04-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study