A Clinical Study to Evaluate SM17 for Atopic Dermatitis

Sponsor
SinoMab BioScience Ltd
Study ID
NCT07445919
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 3, 2026
Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Apr 25, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SM17 Group1
    participants will receive Dose 1 of SM17 with fixed interval 1 from week 0 to week 15, with a loading dose at Week 0
  • Experimental: SM17 Group2
    participants will receive Dose 2 of SM17 with fixed interval 1 from week 0 to week 15，without loading
  • Experimental: SM17 Group3
    participants will receive Dose 3 of SM17 with fixed interval 1 from week 0 to week 15 , with a loading dose at week0
  • Experimental: SM17 Group4
    participants will receive Dose 3 of SM17 with fixed interval 2 from week 0 to week 15, with a loading dose at Week 0
  • Experimental: Open labelled Period
    Start from Week 16 , an open-label treatment period will be applied for all participants upon their discretion. Participants with IGA score 0/1 at week16 will receive Dose 3 of SM17 with Interval 3 until week 20; participants who doesn't reach IGA score 0/1 at week16 will receive Dose 4 of SM17 with Interval 4 until week 20;
  • Placebo Comparator: Placebo group
    Matching placebos for experimental arms 1\~4, participants will receive Dose of SM17 placebo with fixed interval 1 or interval 2 (ratio 3:1) from week 0 to week 15 , with a loading dose at Week 0

Primary Outcome Measure

Efficacy for treating AD - Eczema Area and Severity Index (EASI) [ Time Frame: Week 16 ]

Central Contacts

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